YOUR HEALTH

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com June 1^st, 2009

* When to Get Treatment

* Avoid Pollen

* Medications

* Allergy Shots

Pollen grains from trees, grasses and weeds can float through the air in spring, summer or fall. But on their way to fertilize plants and tree flowers, pollen particles often end up in our noses, eyes, ears and mouths. The result can be sneezing spells, watery eyes, congestion and an itchy throat.

The collection of symptoms that affect the nose when you breathe in something you are allergic to is called allergic rhinitis; when the symptoms affect the eyes, it's called allergic conjunctivitis. Allergic rhinitis caused by plant pollen is commonly called hay fever—although it's not a reaction to hay and it doesn't cause fever.

Pollen allergy affects about 1 out of 10 Americans, according to the National Institute of Allergy and Infectious Diseases (NIAID). For some, symptoms can be controlled by using over-the-counter (OTC) medicine occasionally. Others have reactions that may more seriously disrupt the quality of their lives. Allergies can trigger or worsen asthma and lead to other health problems such as sinus infection (sinusitis) and ear infections in children.

"You can distinguish allergy symptoms from a cold because a cold tends to be short-lived, results in thicker nasal secretions, and is usually associated with sore throat, hoarseness, malaise, and fever," says Badrul Chowdhury, M.D., Ph.D., an allergist and immunologist in the Food and Drug Administration (FDA).

Many people with allergic rhinitis notice a seasonal pattern with their symptoms, but others may need a health care professional's help to find out for sure if pollen is the source of their misery. If symptoms crop up year-round, dust mites, pet dander or another indoor allergy trigger (allergen) could be the culprit. This year-round condition is known as perennial allergic rhinitis.

When to Get Treatment

Chowdhury suggests seeing a health care professional if you experience allergies for the first time, your symptoms interfere with your ability to function, you don't find relief from OTC drugs, or you experience allergy symptoms over a long period.

You may need an allergy test, the most common of which is a skin test that shows how you react to different allergens, including specific pollen allergens like ragweed and grass pollen.

Avoid Pollen

Once you know you have seasonal allergies, try to avoid pollen as much as possible, says Chowdhury. Pay attention to pollen counts and try to stay indoors when pollen levels are highest. Pollen counts measure how much pollen is in the air (pollen level) and are expressed in grains of pollen per square meter of air collected during a 24-hour period.

In the late summer and early fall, during ragweed pollen season, pollen levels are highest in the morning.

In the spring and summer, during the grass pollen season, pollen levels are highest in the evening.

Some molds, another allergy trigger, may also be seasonal. For example, leaf mold is more common in the fall.

Sunny, windy days can be especially troublesome for pollen allergy sufferers.

It may also help to

-keep windows closed in your house and car and run the air conditioner

-avoid mowing grass and doing other yard work, if possible

-wear a face mask designed to filter pollen out of the air and keep it from reaching nasal passages, if you must work outdoors

Medications

FDA regulates medications that offer allergy relief. Here's a rundown of drug options that can help you survive the sneezing season:

Nasal corticosteroids: These are typically sprayed into the nose once or twice a day to treat inflammation. Drugs in this category include Nasonex (mometasone furoate) and Flonase (fluticasone propionate). Side effects may include stinging in the nose.

Oral and nasal antihistamines: These drugs, whether OTC or prescription, counteract the action of histamine, a substance released in the body during an allergic reaction. Benadryl (diphenhydramine) and Chlor-Trimeton (chlorpheniramine) are examples of OTC antihistamines. Drowsiness is a common side effect, so don't take these types of drugs when you have to drive, operate machinery, or do other activities that require you to be alert.

Non-sedating OTC antihistamines include Claritin and Alavert (both loratadine) and Zyrtec (cetirizine). Zyrtec may cause mild drowsiness. Some non-sedating antihistamines, such as Clarinex (desloratadine) and Allegra (fexofenadine), are available by prescription. Many oral antihistamines are available OTC and in generic form.

The prescription drugs Astelin (azelastine) and Patanase (olopatadine) are antihistamine nasal sprays approved to treat allergy symptoms. They can be used several times a day. Side effects include drowsiness, a bitter taste in the mouth, headache, and stinging in the nose.

Decongestants: These drugs, available both by prescription and OTC, come in oral and nasal spray forms. They are sometimes recommended in combination with antihistamines, which used alone do not have an effect on nasal congestion. Allegra D is an example of a drug that contains both an antihistamine (fexofenadine) and a decongestant (pseudoephedrine).

Drugs that contain pseudoephedrine are available without a prescription but are kept behind the pharmacy counter as a safeguard because of their use in making methamphetamine—a powerful, highly addictive stimulant often produced illegally in home laboratories. You will need to ask your pharmacist and show identification to purchase drugs that contain pseudoephedrine.

Using nose sprays and drops more than a few days may give you a "rebound" effect—your nasal congestion will get worse. These drugs are more useful for short-term use to relieve nasal congestion.

Non-steroidal nasal sprays: NasalCrom (cromolyn sodium), an OTC nasal spray, can help prevent symptoms of allergic rhinitis if used before symptoms start. This non-steroidal anti-inflammatory drug (NSAID) needs to be used three to four times a day to be effective.

Leukotriene receptor antagonist: The prescription drug Singulair (montelukast sodium) is approved to treat asthma and to help relieve symptoms of allergic rhinitis. It works by blocking substances in the body called leukotrienes. Side effects may include headache, ear infection, sore throat, and upper respiratory infection.

If you have any other health conditions, check with your health care professional first to determine which OTC medicine to take. For example, people with uncontrolled high blood pressure or serious heart disease shouldn't take decongestants unless directed by a health care professional.

And always read the label before buying an OTC product for you or your children, says Chowdhury. "Some products can be used in children as young as 2 years, but others are not appropriate for children of any age."

Allergy Shots

People who don't respond to either OTC or prescription medications, or who suffer from frequent complications of allergic rhinitis, may be candidates for immunotherapy, commonly known as allergy shots.

According to NIAID, about 80 percent of people with hay fever will experience a significant reduction in their symptoms and their need for medication within a year of starting allergy shots.

"Discuss the option of immunotherapy with your doctor thoroughly because immunotherapy is not for everybody, and there is a significant time commitment involved," Chowdhury says.

The process involves receiving injections of small amounts of allergens that are considered to be responsible for your symptoms. The doses are gradually increased so that the body builds up immunity to the allergens. The injections are given over at least three to five years. Discontinuation is based on having minimal symptoms over two consecutive seasons of exposure to allergens.

This article appears on FDA's Consumer page http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm153549.htm , which features the latest on all FDA-regulated products.

e-published on MedicineandBiotech.com April, 2009

--Diagnosing the Disease

--Types of Antidepressants

--Selecting Antidepressants

--Effectiveness of Antidepressants

--Managing Side Effects

--Serious Risks

Depression affects about 121 million people worldwide and is a leading cause of disability, according to the World Health Organization (WHO).

"In my experience as a practicing psychiatrist, I've seen that many people with depression don't realize that they have the condition or that it's treatable," says Mitchell Mathis, M.D., deputy director of the Division of Psychiatry Products at the Food and Drug Administration (FDA).

Some who suffer from depression don't recognize the symptoms, or they attribute them to lack of sleep or a poor diet. Others realize they are depressed, but they feel too fatigued or ashamed to seek help.

Not all depression requires treatment with medication.

"Studies have shown that the best way to treat a patient with the more severe form of major depressive disorder is through both therapy and prescribed antidepressant medication," Mathis says. "They work best in combination with one another."

Diagnosing the Disease

Medical professionals generally base a diagnosis of major depressive disorder on the presence of certain symptoms listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Diagnosis depends on the number, severity, and duration of these symptoms:

--depressed mood

--loss of interest or pleasure in almost all activities

--changes in appetite or weight

--disturbed sleep

--slowed or restless movements

--fatigue, loss of energy

--feelings of worthlessness or excessive guilt

--trouble in thinking, concentrating, or making decisions

--recurring thoughts of death or suicide

Types of Antidepressants

Antidepressants work to normalize naturally occurring brain chemicals called neurotransmitters—primarily serotonin, norepinephrine, and dopamine. Scientists have found that these particular chemicals are involved in regulating a person's mood.

There are several different classifications of antidepressants:

Selective Serotonin Reuptake Inhibitors (SSRIs): Examples are Prozac (fluoxetine), Celexa (citalopram), and Paxil (paroxetine).

Serotonin and Norepinephrine Reuptake Inhibitors (SSNIs): Examples are Effexor (venlafaxine) and Cymbalta (duloxetine).

Tricyclic antidepressants (TCAs): Examples are Elavil (amitriptyline), Tofranil (imipramine), and Pamelor (nortriptyline).

Monoamine Oxidase Inhibitors (MAOIs): Examples are Nardil (phenelzine) and Parnate (tranylcypromine).

There are other antidepressants that don't fall into any of these classifications and are considered unique, such as:

Remeron (mirtazapine)

Wellbutrin (bupropion)

The antidepressant medications in each classification affect different neurotransmitters in particular ways. For example, SSRIs increase the production of serotonin in the brain. MAOIs block monoamine oxidase, an enzyme that breaks down neurotransmitters. Blocking their breakdown means that neurotransmitters remain active in the brain. Research is ongoing to determine antidepressants' exact mechanism of action on a person's brain.

Selecting Antidepressants

So how does a physician determine which antidepressant to prescribe? Doctors typically use a patient history and a mental status exam. With this information, the doctor can evaluate symptoms, rule out medical causes of depression, and decide if the criteria are met for major depressive disorder.

"In my opinion, it's best when antidepressant medications are personalized," says Mathis. "For example, some depressed people have difficulty sleeping. So they would benefit from a more sedating antidepressant at night. Other people with depression sleep too much and would benefit from a more activating antidepressant in the morning."

It's important to communicate how you are feeling so that your physician can evaluate the medication's effectiveness.

Effectiveness of Antidepressants

Approximately 60 to 70 percent of patients respond to the first antidepressant that is prescribed or to an increased dosage of that drug, according to Mathis.

But patients must take regular doses of a prescribed antidepressant for at least 3 to 4 weeks before they are likely to experience the full therapeutic effect. And if patients start to feel better, they should not stop taking the antidepressant.

"Even if you start to feel better, you may be in between episodes," says Mathis. "Depression tends to be chronic and requires everyday treatment just like high blood pressure."

If you get used to an antidepressant and just quit it, you may experience some withdrawal symptoms such as anxiety and irritability. Worst of all, depression may recur.

Patients should continue taking an antidepressant for 6 to 12 months, or in some cases longer, according to the National Institute of Mental Health (NIMH). This gives medication time to be effective and can help prevent a relapse of the depression. Patients should carefully follow their doctor's instructions.

Mathis estimates that about 10 percent of depressions are treatment resistant and won't respond to prescribed antidepressants.

That means that 20 to 30 percent of patients may not respond to the first antidepressant that is prescribed for them. NIMH-funded research has shown that patients who did not get well after taking a first medication increased their chances of becoming symptom-free after they switched to a different medication or added another medication to their existing one.

With appropriate treatment, many people with depression experience improvement of their symptoms and return to living normal and productive lives.

Managing Side Effects

All antidepressants come with Medication Guides. These guides provide FDA-approved information for patients, families, and caregivers that could help improve monitoring of a drug's effects. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Many people who take antidepressants have at least one side effect. Side effects can include:

Headache

Night sweats

Nausea

Agitation

Sexual problems

Dry mouth

Constipation

Side effects are the most common reason people stop taking antidepressants. It's recommended that you don't stop taking your antidepressants or reduce the dosage without talking to your doctor or mental health professional first.

And there are coping strategies for the most common side effects of antidepressants. For a more complete list of side effects and suggested coping strategies, visit www.nimh.nih.gov/health/publications/medications/antidepressant-medications.shtml

Serious Risks

Suicidal Thinking: In October 2004, FDA directed manufacturers to add a boxed warning to the labeling of all antidepressant medications to alert the public about the increased risk of suicidal thinking or suicide attempts by children and adolescents taking antidepressants.

A boxed warning is the most serious type of warning used on prescription drug labeling. In May 2007, FDA directed that the warning should be extended to include young adults up through age 24.

More detailed analysis by FDA of antidepressant clinical trials showed an increased risk of suicidality—suicidal thoughts or behavior. "There weren't more actual suicides, but more people under 24 were thinking or talking about it," explains Mathis. "This occurs most often within the first 30 days of an adolescent or young adult starting on an antidepressant."

Mania: When people are in a manic "high," they may be overactive, overly talkative, have a great deal of energy, and need less sleep than normal.

There are two different types of mood disorders, both of which are cyclical. One is unipolar disorder, in which the cycle is that a person feels normal and then feels depressed. The other type is bipolar disorder, in which the person's mood cycles from depressed to normal to manic.

"The doctor needs to screen patients for a bipolar history," said Mathis. If an antidepressant is prescribed to a person with bipolar disorder, it can cause mania. And the person can even become psychotic if the mania is severe.

Birth Defects: In December 2005, FDA changed Paxil (paroxetine) from a pregnancy risk category of C to D. With a Category C drug, fetal risk can't be ruled out. With a Category D drug, positive evidence of fetal risk exists. FDA chooses a medicine's letter category based on what is known about the medicine when used in pregnant women and animals.

High Blood Pressure: It can be much more difficult for patients to take one of the MAOIs for depression because of the many dietary and medicinal restrictions that must be followed. People taking MAOIs must avoid certain foods that contain high levels of the chemical tyramine, which is found in many cheeses, wines and pickles, and some medications including decongestants. MAOIs interact with tyramine in such a way that may cause a sharp increase in blood pressure, which could lead to a stroke or other complications.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html .

For More Information

Antidepressant Use in Children, Adolescents, and Adults

www.fda.gov/cder/drug/antidepressants/default.htm

National Institute of Mental Health (NIMH)

www.nimh.nih.gov/

Arthritis may create an additional barrier to using physical activity to help people manage their heart disease, according to a study by the Centers for Disease Control and Prevention. Adults with both heart disease and arthritis are significantly more likely to be physically inactive than those with heart disease alone, the study said.

The study in the Morbidity and Mortality Weekly Report (MMWR), found that arthritis is common among those having heart disease. Approximately 57 percent of adults with heart disease have arthritis.

In the study, about 29 percent of adults with arthritis and heart disease were inactive, compared to 21 percent of people with heart disease alone, 18 percent of those with arthritis, and 11 percent of adults with neither condition.

“Engaging in regular physical activity can help reduce arthritis pain and improve joint function, which in turn can help people with heart disease get more active and better manage both conditions,” said Chad Helmick, M.D., a CDC medical epidemiologist and coauthor of the study.

The study, based on combined 2005 and 2007 Behavioral Risk Factor Surveillance System data, show that the prevalence of physical inactivity for adults with both heart disease and arthritis varied substantially from state to state — ranging from 20.5 percent in Colorado to 50.3 percent in Kentucky.

“Unfortunately, many people living with both arthritis and heart disease seldom or never exercise because they may be unsure about which activities are safe and worry about aggravating their joint or heart problems,” said Janet Collins, Ph.D., director of CDC′s National Center for Chronic Disease Prevention and Health Promotion. “These fears are readily addressed by good information, consultation with their doctor, evidence-based programs, and strong social support.”

Nationwide, 14.1 million adults have heart disease. Inactive persons with heart disease who increase activity benefit from improved physical function and lowered blood pressure and blood cholesterol levels. Joint-friendly activities, such as walking, swimming, and biking, and specially tailored self-management education and exercise programs are safe and can improve health for adults with both conditions.

Disease self-management classes, including exercise programs that address arthritis-specific barriers, may help adults with arthritis and heart disease. Programs proven to be effective in managing arthritis, such as the Chronic Disease Self-Management Program, the Arthritis Foundation′s Exercise Program, and Enhance Fitness, are available in many communities.

For more information on joint-friendly exercise programs, visit CDC′s arthritis Web site at http://www.cdc.gov/arthritis/intervention. For general information about heart disease, visit CDC′s heart disease Web site at http://www.cdc.gov/heartdisease.

####

Update on FDA's Investigation: February 1, 2009

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com February 1, 2009

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have enabled FDA to confirm that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant.

Peanut butter is sold by PCA in bulk containers ranging in size from five (5) to 1,700 pounds.  The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container.  Neither of these products is sold directly to consumers.  However, through its investigation, FDA has determined that PCA distributed potentially contaminated product to more than 100 consignee firms, for use as an ingredient in hundreds of different products, such as cookies, crackers, cereal, candy and ice cream.

FDA initiated an inspection of PCA’s Blakely plant on January 9 shortly after learning that this firm might be linked to the ongoing Salmonella outbreak.  FDA finished its inspection on January 27.  A list of problems observed by FDA investigators during their inspection is available at this link: http://www.fda.gov/ora/frequent/default.htm.  This list is not a final agency determination regarding compliance.  The deficiencies observed indicate that the plant was not compliant with Current Good Manufacturing Practices required by the FDA.  These deficiencies are related to cleaning programs and procedures as well as failure to implement steps to mitigate Salmonella contamination in the facility.

On January 29, PCA issued an expanded voluntary recall of all peanuts and peanut products processed in its Blakely, Georgia facility since January 1, 2007.  The expanded recall includes all peanuts (dry and oil roasted), granulated peanuts, peanut meal, peanut butter and peanut paste.  All of the recalled peanuts and peanut products were made only at the company’s Blakely, Georgia facility. 

On January 30, FDA confirmed that FDA’s Office of Criminal Investigations is involved in a Justice Department investigation of PCA.

FDA has been working with the company and purchasers of PCA's peanut butter and peanut paste to identify affected products and facilitate their removal from the market.  FDA and state officials have visited in excess of 1,000 firms who purchased PCA products.  Now, the same type of work is continuing and includes the additional products in the expanded recall.

Companies nationwide that received product made by PCA have issued voluntary recalls of their products.  As FDA gathers additional information about these products, the list of recalled products is expected to expand.  FDA has created a searchable database for these products, which can be found at http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm. The list is updated frequently.

Product recalls include some pet food products that contain peanut paste that was made by PCA. While the risk of animals contracting salmonellosis is minimal, there is risk to humans from handling these products. It is important for people to wash their hands--and make sure children wash their hands--before and, especially, after feeding treats to pets. Further information for consumers is located in the Frequently Asked Questions section located on this web site. The pet food products are also included in the searchable data base of recalled products.

Major national brands of jarred peanut butter found in grocery stores are not affected by the PCA recall. 

FDA and CDC recommendations for consumers include:

• Consumers are urged to check FDA’s web site to determine which products have been recalled and will be recalled in the coming days.
  Any product that is on the recall list should be disposed of in a safe manner.  Consumers are also urged to wash their hands after handling potentially contaminated products.
• If consumers are unsure whether a peanut-containing product is potentially contaminated, they should avoid consuming it or feeding it to their pet until they obtain more information regarding the product.
• Persons who think they may have become ill from eating peanut products are advised to consult their health care providers.

For Retailers

• Stop selling recalled products.

For Directors of Institutions and Food Service Establishments

• Ensure that they are not serving recalled products.

For Manufacturers

• Inform consumers about whether their products could contain peanuts or peanut products  from the Peanut Corporation of America (PCA).  If a manufacturer knows its products do not contain peanuts or peanut products from PCA, it may wish to provide this information to consumers. For specific guidance: Guidance for Industry: Product Recalls, Including Removals and Corrections

The FDA will closely monitor these events by continuing to work with the firms on the details of their actions, conducting follow-up audits and inspections, monitoring the progress of the firms’ actions, working with state and local regulatory authorities, and notifying our foreign regulatory counterparts of products that have now been confirmed as having been distributed internationally.

Ongoing Investigation

FDA has collaborated with the Centers for Disease Control and Prevention (CDC) and public health officials in various states to investigate the multi-state outbreak of human infections due to Salmonella Typhimurium.  An epidemiological investigation by the Minnesota Department of Health isolated and tested subsamples from an open five-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened by the outbreak strain of Salmonella Typhimurium. The Minnesota Health officials found the peanut butter contained the same strain of Salmonella Typhimurium associated with the illnesses linked to the outbreak. 

Because it is always possible that the open container was contaminated by someone or something else in the environment, the FDA and the states began testing unopened containers of the same brand of peanut butter.  King Nut distributes peanut butter manufactured by the PCA to institutional facilities, food service industries, and private label food companies in several states. 

On January 19, 2009, testing by the Connecticut Department of Health of an unopened container of King Nut peanut butter showed that it too contained the same strain of Salmonella Typhimurium associated with illnesses linked to the outbreak. The fact that the Salmonella Typhimurium was confirmed in an unopened container of peanut butter indicates that peanut butter originating from the processing plant was contaminated.
FDA has initiated inspections at the direct consignees of PCA and King Nut and continues to follow the distribution points for products.

The FDA has no evidence to suggest that the Salmonella Typhimurium contamination originated with any manufacturing facility other than PCA. The PCA facility in Blakely, Georgia is not operating at this time and the company has recalled all peanuts and peanut products produced there from January 1, 2007, to the present. 

The FDA and food manufacturers are working to identify products that may be affected, and to track the ingredient supply chain of those products to facilitate their removal from the marketplace.

For the latest information on the outbreak and the epidemiological investigation, including number of illnesses and a list of states reporting illnesses, go to the CDC web page at http://www.cdc.gov/salmonella/typhimurium/ .

Search Combined List of Recalled Products

• Search Combined List of Recalled Products (Browse by food brand or do a search)

News Updates

• FDA/CDC Joint Media Teleconference (January 28) Audio [6.44 MB MP3]
• FDA/CDC Joint Media Teleconference (January 27) Audio [5 MB MP3]
• Update on FDA's Investigation (January 19)
• FDA/CDC Joint Media Teleconference (January 21)
• Update on FDA's Investigation (January 18)
• FDA/CDC Joint Media Teleconference (January 17)
• FDA/CDC Joint Media Teleconference (January 16)
• Update on FDA's Investigation (January 17)
• Update on FDA's Investigation (January 16)
• Update on FDA's Investigation (January 12)

List of Company Recalls

• Pecan Deluxe Candy Company Announces Nationwide Voluntary Recall of Certain Peanut Containing Products (February 1) New!
• Velvet Ice Cream Pulling Cone Products (January 30) New!
• Kroger Recalls Peanut Butter Bakery Cookies and Select Cakes Due to Possible Health Risk (January 31) New!
• Rucker's Candy Announces Voluntary Recall for Customer Private Labeled Products Including The Family Choice Labeled Brand (January 31) New!
• Mountain Man Nut & Fruit Co.® Announces Nationwide Voluntary Recall of Select Products Due to Possible Health Risk (January 30)
• Best Brands Corp. Expands Voluntary Recall of Peanut Butter Frozen Cookie Dough (January 30)
• East Side Entrees Voluntarily Recalls Peanut Butter & Jelly Meal Breaks Because of Possible Health Risk (January 31)
• Zachary Confections, Inc. Announces a Nationwide Voluntary Recall of Market Pantry Chocolate Covered Peanuts (January 31)
• Zachary Confections, Inc. Announces Nationwide Recall of Double Dipped Peanuts, Chocolate Peanuts, Bridge Mix, Caramel Nut Clusters, and Peanut Clusters due to Possible Peanut Corporation of America (PCA) Contamination and Possible Health Risk (January 31)
• Schwan Voluntarily Recalls Ice Cream Citing Possible Health Risk (January 31)
• Standard Candy announces Voluntary Recall of Goo Goo Cluster and Goo Goo Peanut Butter because of possible Health Risk (January 31)
• Hain Celestial Voluntarily Issues Nationwide Recall of Certain Ethnic Gourmet® Pad Thai And Kung Pao Frozen Food Products, And Certain Gluten Free™ Café Asian Curry Products, Because of Possible Health Risk (January 31)
• Bass Pro Shops® Announces Voluntary Nationwide Recall of Uncle Bucks® Burnt Peanut Candy, No Sugar Added Chocolate Peanuts And No Sugar Added Peanut Clusters Due to Possible Health Risk (January 31)
• Publix Issues Voluntary Recall on Round Top Sundae Cones (January 29)
• Publix Issues Voluntary Recall on Produce Snacks (January 30)
• Kemps LLC Recalls Ice Cream Products (January 30)
• Pierre's Ice Cream Company Issues Voluntary Recall on its Pierre’s Brand Sundae-Cone Style Products Due to Expanded Peanut Recall by Peanut Corporation of America (PCA) (January 30)
• Nature’s Path Announces an Expanded Recall of Peanut Butter Optimum Energy Bars Nationwide Due to Possible Health Risk (January 31)
• HP Hood LLC Recalls Ice Cream Products (January 30)
• Bear Naked Announces Recall of Appalachian Trail Mixes Due to Possible Peanut Corporation of America Contamination and Potential Health Risk (January 31)
• Ice Cream Specialties Announces Nationwide Recall of Ice Cream Novelties Because of Possible Health Risk (January 31)
• Salix, LLC Recalls 6" Peanut Butter Filled Shank Bone Because Of Possible Salmonella Health Risk (January 30)
• Weis Markets Announces Voluntary Recall of Seven Ice Cream Products Due to Possible Health Risk (January 30)
• Harry and David Recalls Olympia Delight Trail Mix Because of Possible Health Risk (January 29)
• Perry's Ice Cream Company Adds Products to Voluntary Recall of Select Peanut Butter Ice Cream Products as a result of PCA Expanded Recall (January 30)
• Kroger Recalls Nut Topping Due to Possible Health Risk (January 30)
• Clif Bar & Company Expands Its Voluntary Nationwide Recall Of CLIF® and LUNA® Branded Bars Containing Peanut Butter (January 30)
• Lesserevil Brand Snack Co. Issues a Nationwide Voluntary Recall of Lesserevil Brand Peanut Butter and Choco Kettle Corn (January 30)
• Wells’ Dairy Expands Voluntary Recall of Select Blue Bunny® Products (January 30)
• House of Flavors Issues Voluntary Recall in Eastern United States Due to Possible Health Risk (January 30)
• NutriSystem Expands Voluntary United States Recall of Peanut Butter Granola Breakfast Bar to Include Canada Due to Possible Peanut Corporation Of America (PCA) Contamination and Potential Health Risk (January 30)
• Turkey Hill Dairy Announces Voluntary Recall of Select Ice Cream Flavors Following Expanded FDA Investigation of Peanut Corporation of America (January 30)
• Voluntary Recall Alert: Chef Pierre Chocolate Peanut Butter Silk Pie (January 30)
• Simbree Energy Foods RECALLS Simbree® Oat Almond Pistash, Simbree® Almond Pistachio Energy Bites and Simbree® Oat Bites with Peanuts, Almonds and Pistachios/ Bouchées d’avoine aux arachides, amandes et pistaches Because of Possible Health Risk (January 30)
• Arico Natural Foods Company Announces US and Canadian Recall of Arico Peanut Butter Cookies and Cookie Bars Because of Possible Health Risk (January 29)
• Galliker Dairy Announces Voluntary Recall of Rocky Road Ice Cream and Sundae Nut Cones Because of Possible Health Risk (January 30)
• Rain Creek Baking Corporation Announces An Expanded Voluntary Withdrawal of Peanut Butter Turtles, Peanut Butter Baskets and Peanut Butter Princesses Due to Possible Health Risk (January 30)
• Orchard Valley Harvest Announces Urgent Nationwide Voluntary Recall for Peanuts Because of Possible Health Risk (January 29)
• Country Maid Expands Upon Previous Voluntary Nationwide Recall of Classic Breaks Peanut Butter Cookie Dough Due to Possible Health Risk (January 29)
• Hy-Vee Inc. Recalls Two Bakery Products with Peanuts Distributed in Seven States Due to Possible Health Risk (January 29)
• Meijer Announces Voluntary Recall for Some Meijer Brand Peanuts and Ice Cream Novelties Citing Possible Health Risk (January 30)
• Fieldbrook Foods Corp. Announces Nationwide Voluntary Recall of Select Ice Cream Novelty Products Due to Possible Health Risk (January 29)
• Wells' Dairy Announces Voluntary Recall of Select Blue Bunny Products Because of Possible Health Risk (January 29)
• Wegmans Food Markets, Inc. Recalls Three Bakery Products with Peanuts (January 29)
• Uncle Eddies Vegan Cookies Announces Recall of Uncle Eddies Vegan Peanut Butter Chocolate-Chip Cookies Because of Possible Health Risk (January 28)
• Peanut Corporation of America Expands Nationwide Recall of Peanut Products (January 28)
• H-E-B Recalls H-E-Buddy Snack Packs With a Peanut Butter Dip (January 17)
• Isagenix Announces Voluntary Recall of Chocolate Dipped Honey Peanut IsaLean® Bar Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk (January 27)
• Jenny Craig Announces Nationwide Voluntary Recall of Jenny’s Cuisine® Anytime Peanut Butter Flavor Nutritional Bars Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk (January 27)
• Salix Voluntarily Recalls Dog Treat Due to Possible Health Risk (January 23)
• Carolina Prime Pet Announces Nationwide Recall of Dog Treats (January 27)
• ALDI Statement Regarding Peanut Butter Products Recall (January 23)
• Creative Energy Foods, Inc. Recalls Nutrition Bars Due To Possible Health Risk (January 21)
• SOPAKCO, Inc. Announces a Nationwide Recall of Certain SURE-PAK 12 Meals Containing Peanut Butter Products (January 27)
• Falcon Trading Company/SunRidge Farms Withdraws Naturally Preferred Honey Nut Nuggets (January 23)
• Falcon Trading Company/SunRidge Farms Withdraws Certain Lots of SunRidge Tropical Golden Nugget, SunRidge Chocolate Energy Bar and SunRidge Energy Nuggets (January 23)
• Trader Joe’s Expands Its Voluntary Recall To Include Trader Joe’s Sliced Green Apples With All Natural Peanut Butter (January 23)
• Supreme Protein Voluntarily Recalls Supreme Protein® brand Peanut Butter Crunch Bars and Caramel Nut Bars (January 23)
• Voluntary Recall Issued for ShopRite Peanut Butter on Toasty Crackers and ShopRite Peanut Butter and Cheese Cracker Snacks Because of Possible Health Risk (January 24)
• General Mills Issues Voluntary Recall of LÄRABAR and JamFrakas Peanut Butter Snack Bars (January 19)
• Whole Foods Market Recalls "Whole Foods Carob Energee Nuggets” (January 23)
• Amway Global Initiates Nationwide Recall of NUTRILITE Energy Bars Because of Possible Health Risk (January 23)
• Brent and Sam’s Announces Nation Wide Recall of Two Varieties of Archer Farms Brand Cookies (January 23)
• Brent and Sam’s Announces a Nationwide Recall of One Variety of Sam’s Choice Brand Cookies (January 23)
• Trader Joe’s Announces Voluntary Recall of Trader Joe’s Peanut Butter Chewy Coated & Drizzled Granola Bars, Nutty Chocolate Chewy Coated & Drizzled Granola Bars and Sutter’s Formula Cookies Due to Possible Health Risk (January 22)
• Parker Products, Inc. Announces Nationwide Voluntary Recall of Certain Peanut Butter Products (January 22)
• Arbonne International Voluntarily Recalls Figure 8 Peanut Butter Chews Due To Possible Health Risk (January 22)
• Jimmy's Cookies Issues Nationwide Recall of Various Peanut Butter Cookies Due to Possible Health Risk (January 22)
• Perry's Ice Cream Company Adds Two Products to Voluntary Recall of Select Peanut Butter Ice Cream Products (January 22)
• Kroger Recalls Additional Select Ice Cream Product Due to Possible Health Risk (January 20)
• General Nutrition Centers, Inc. Announces Nationwide Voluntary Recall of Certain Lots of GNC Triflex Peanut Butter Soft Chews (January 22)
• Chef Jay’s Food Products Announces Voluntary Nationwide Recall of Products Containing Peanut Butter Due to Possible Health Risk (January 21)
• Rain Creek Baking Corporation Announces Voluntary Withdrawal of Peanut Butter Turtles, Peanut Butter Baskets and Peanut Butter Princesses Due to Possible Health Risk (January 22)
• South Bend Chocolate Company Extends Nationwide Recall of Candy Containing Peanut Butter Because of Possible Salmonella Contamination (January 22)
• Nash Finch Recalls Bakery Products With Peanut Butter Distributed in Seven States Due to Possible Health Risk (January 20)
• Aspen Hills, Inc. Announces Voluntary Product Recall of Certain Cookie Dough Products (January 22)
• Best Brands Corp. Announces Voluntary Recall of Peanut Butter Frozen Cookie Dough (January 21)
• Lovin Oven, LLC Announces Voluntary Nationwide Recall of Certain Health Valley Organic Peanut Crunch Chewy Granola Bars (January 21)
• Landies Candies Co. Inc Announces Voluntary Recall of Select Peanut Butter Filled Chocolates Due to Possible Health Risk (January 21)
• Weis Markets Announces Voluntary Recall of Weis Quality (WQ) Cheese Peanut Butter Sandwich Crackers and WQ Toasted Peanut Butter Sandwich Crackers Due to Possible Health Risk (January 20)
• Blanton's Candies Recalls Peanut Butter Sticks Because of Possible Health Risk (January 21)
• Dinners Ready Meridian Recalls November & December Asian Marinated Flank Steak, Indonesian Chicken and Chicken Satay Prepared Meals Because of Possible Health Risk (January 20)
• Boca Grande Foods Announces a Nationwide Recall of POCO PAC®, and GRANDE GOURMET™ Peanut Butter Products Because of Possible Health Risk (January 20)
• Premier Nutrition Announces Voluntary Nationwide Recall of selected TWISTED and TITAN Branded Bars Containing Peanut Butter Due to Possible Health Risk (January 20)
• NutriSystem Announces Nationwide Voluntary Recall of Peanut Butter Granola Bar Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk (January 21)
• Ready Pac Foods, Inc Announces Voluntary Product Recall (January 20)
• PetSmart Voluntarily Recalls Grreat Choice® Dog Biscuits (January 20)
• Nature's Path Recalls Peanut Butter Optimum Energy Bars Nationwide Because of Possible Health Risk (January 20)
• Country Maid Announces Voluntary Nationwide Recall of Classic Breaks® Peanut Butter Cookie Dough Due to Possible Health Risk (January 20)
• Evening Rise Bread Co. Recalls Peanut Butter Cookies and Bars Because of Possible Health Risk (January 19)
• Clif Bar & Company Announces Voluntary Nationwide Recall of CLIF® and LUNA® Branded Bars Containing Peanut Butter Due to Possible Health Risk (January 19)
• Kroger Recalls Select Ice Cream Products Due to Possible Health Risk (January 19)
• Abbott Nutrition Announces Voluntary Recall of ZonePerfect® Chocolate Peanut Butter Bars, ZonePerfect® Peanut Toffee Bars and NutriPals™ Peanut Butter Chocolate Bars in U.S., Mexico, New Zealand and Singapore (January 19)
• Meijer Announces Voluntary Recall for Some Meijer Brand Peanut Butter Crackers and Ice Cream Because of Possible Health Risk (January 19)
• Peanut Corporation of America Expands Nationwide Recall of Peanut Butter (January 18)
• Ralcorp Frozen Bakery Products Recalls Wal-Mart Bakery Brand Peanut Butter Cookies Because Of Possible Health Risk (January 18)
• Ralcorp Frozen Bakery Products Recalls Lofthouse Peanut Butter Cookies, Chuck's Chunky Peanut Butter Cookies And Pastries Plus Gourmet Cookies Nationwide Because Of Possible Health Risk (January 18)
• Ralcorp Frozen Bakery Products Recalls Food Lion Bake Shop Peanut Butter Cookies Nationwide Because Of Possible Health Risk (January 18)
• South Bend Chocolate Company Recalls Various Candys Containing Peanut Butter Because of Possible Salmonella Contamination (January 18)
• McKee Foods Corporation Announces Voluntary Nationwide Recall of Little Debbie® Peanut Butter Toasty and Peanut Butter Cheese Sandwich Crackers Because of Possible Health Risk (January 18)
• Perry's Ice Cream Company Announces Voluntary Recall of Select Peanut Butter Ice Cream Products Due to Possible Health Risk (January 17)
• Hy-Vee Inc. Recalls Bakery Products With Peanut Butter Distributed in Seven States Due to Possible Health Risk (January 17)
• Peanut Corporation of America Expands Nationwide Recall of Peanut Butter (January 16)
• Kellogg Company Announces Voluntary Nationwide Recall of Austin® and Keebler® Branded Peanut Butter Sandwich Crackers and Select Snack-Size Packs of Famous Amos® And Keebler® Soft Batch Peanut Butter Cookies Because of Possible Health Risk (January 16) [En Español]
• Peanut Corporation of America Announces Voluntary Nationwide Recall of Peanut Butter (January 13)
• King Nut Issues Peanut Butter Recall (January 10)

Company Action

• Kellogg Company Announces Precautionary Hold on Austin and Keebler Branded Peanut Butter Sandwich Crackers (January 14)

State Reports

• Salmonella-Tainted Peanut Butter Found in Connecticut (January 16)
• Salmonella recovered from King Nut peanut butter by MDA lab found to be a genetic match to cases in national Salmonella outbreak (January 12)

Information for Industry

• Guidance for Industry: Product Recalls, Including Removals and Corrections

Information for Consumers

• Frequently Asked Questions and Answers about the Recent Salmonella OutbreakUpdated!

Information About Salmonella

• For More Information About CDC's Outbreak Investigation (CDC)
• General Information: Salmonella (CDC)
• Questions & Answers: Salmonella (CDC)

How Do I Report a Complaint?

• Please contact your Consumer Complaint Coordinator

Agency seeks recall of products that pose serious health risks

Credit: FDA Consumer Health Information

The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

The tainted weight loss products are:

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers. 

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products. 

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.
 
Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

Information for consumers can be found at:
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here: http://www.fda.gov/cder/Guidance/6911fnl.htm.

Vaccines Stand Ready for Flu Season

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.cm November 1^st, 2008

Commonly called "the flu," influenza is a virus-induced, contagious respiratory illness. The Food and Drug Administration (FDA) plays a key role in protecting Americans against seasonal strains of flu. Assuring the safety of influenza vaccine is one of the agency's top priorities. So is ensuring that there's enough vaccine for everyone who wants it—especially for people who are at risk of complications of influenza.

There are two kinds of influenza vaccines:

-The flu shot contains inactivated, or killed, influenza viruses.

-The nasal vaccine is known by the trade name of FluMist. It contains weakened, live viruses, and is sprayed into both nostrils.

Autumn is the best time to get vaccinated, although getting the vaccine in the winter months when flu season often peaks is also recommended.

Six Vaccines for This 2008-2009 Season

FDA has approved six vaccines for the 2008-2009 flu season. All are for use against influenza disease caused by influenza virus types A and B. They are

Afluria, for adults 18 years of age and older

Fluarix, for adults 18 years of age and older

FluLaval, for adults 18 years of age and older

Fluvirin, for people 4 years of age and older

Fluzone, for people 6 months of age and older

FluMist, for people ages 2 to 49

Manufacturers of the six vaccines project about 146 million doses will be available for this influenza season, according to the U.S. Centers for Disease Control and Prevention (CDC).

A Challenging Process

"One of the biggest challenges in the fight against influenza is producing new vaccines every year," says Jesse L. Goodman, M.D., M.P.H., Director of FDA's Center for Biologics Evaluation and Research. "There is no other instance where new vaccines must be made every year. The approval of flu vaccines is a part of FDA's mission to promote the health of Americans throughout the year."

Experts from FDA, CDC, the World Health Organization, and other institutions annually study virus samples and disease patterns collected worldwide in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of its Advisory Committee, FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. Each season's vaccines are modified to reflect the virus strains most likely to be circulating and cause the flu.

In an unusual occurrence, FDA changed all three strains for this year's influenza vaccine. Usually, only one or two strains are updated from year to year.

This year's vaccines include the following strains:

an A/Brisbane/59/2007 (H1N1)-like virus

an A/Brisbane/10/2007 (H3N2)-like virus

a B/Florida/4/2006-like virus

Health Professionals Need It Too

The approach of flu season also serves to remind health care workers to get vaccinated against influenza. The U.S. Department of Health and Human Services (HHS) recently launched an initiative to help improve vaccination rates among health care personnel.

Influenza vaccination should be considered a part of patient safety. Studies have shown that only about 4 in 10 health care professionals are vaccinated every year. Those that don't get vaccinated can cause influenza outbreaks in health care settings.

Flu Facts

What are the symptoms? Seasonal influenza—or flu—is a contagious respiratory illness caused by viruses. Symptoms include fever, headache, body aches, chills, extreme exhaustion, and weakness.

How is it spread? Flu is spread through coughing or sneezing. You can also get it by touching objects that are carrying the virus, such as telephones and door knobs, and then touching your mouth or nose. Wash your hands often and teach children to do the same. Most healthy adults may be able to infect others one day before their own symptoms develop and up to five days after becoming sick.

How many people are affected? Each year, according to CDC, an average of 5% to 20% of the U.S. population gets the flu. More than 200,000 people are hospitalized from flu complications. There are about 36,000 flu-related deaths each year.

What are the possible complications? Most people recover from the flu within one to two weeks. But some develop serious complications such as pneumonia, ear infections, sinus infections, dehydration, and worsening of chronic medical conditions such as congestive heart failure, asthma, or diabetes.

Who is at higher risk for complications? Some individuals—particularly elderly people, young children, and people with chronic medical conditions—are at higher risk for flu-related complications. Vaccination of these groups and of health care personnel is critical.

Can you get the flu from a flu shot? Although some people get a mild fever, body aches, and fatigue for a few days, you can't get the flu from a flu shot. Soreness at the injection site is a common side effect of the flu shot

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer ), which features the latest updates on FDA-regulated products.

For More Information

FDA's Flu Information Web Site

www.fda.gov/oc/opacom/hottopics/flu.htm l

Information on Approved Influenza Vaccines

www.fda.gov/cber/efoi/approve.htm#flu   

FDA Approves 2008-2009 Flu Vaccines

www.fda.gov/bbs/topics/NEWS/2008/NEW01872.html

Health Care Personnel Initiative to Improve Influenza Vaccination Toolkit

www.hhs.gov/ophs/programs/initiatives/vacctoolkit/index.html

More than 54,000 infants and young children have sought medical treatment in relation to the melamine-contaminated dairy products in China, causing kidney stone. Three deaths among infants have been confirmed, more than 13,000 infants are in hospital. Kidney stones in infants are normally very rare.

The World Health Organization has published “Melamine and Cyanuric acid: Toxicity, Preliminary Risk Assessment and Guidance on Levels in Food”. http://www.who.int/foodsafety/fs_management/Melamine.pdf

This preliminary guidance was developed to assist national authorities in the decision-making process on deciding possible health concern of melamine levels in food. This preliminary guidance is proposed as a first pragmatic approach until more data become available which would allow a more detailed assessment.

Questions and Answers on Melamine

Source: WHO

What is melamine?

Melamine is an organic base chemical most commonly found in the form of white crystals rich in nitrogen

What is melamine generally used for?

Melamine is widely used in plastics, adhesives, countertops, dishware, whiteboards.

Why was melamine added into milk and powdered infant formula

In China, where adulteration has occurred, water has been added to raw milk to increase its volume. As a result of this dilution the milk has a lower protein concentration. Companies using the milk for further production (e.g. of powdered infant formula) normally check the protein level through a test measuring nitrogen content. The addition of melamine increases the nitrogen content of the milk and therefore its apparent protein content.

Addition of melamine into food is not approved by the FAO/WHO Codex Alimentarius (food standard commission), or by any national authorities.

Has melamine been found in other food products?

In 2007, melamine was found in wheat gluten and rice protein concentrate exported from China and used in the manufacture of pet food in the United States. This caused the death of a large number of dogs and cats due to kidney failure.

In the present event, melamine contamination has been found in a number of different brands of powdered infant formula, in one brand of a frozen yogurt dessert and in one brand of canned coffee drink. All these products were most probably manufactured using ingredients made from melamine-contaminated milk.

What are the health effects of melamine consumptions in humans?

While there are no direct human studies on the effect of melamine data from animal studies can be used to predict adverse health effects. Melamine alone causes bladder stones in animal tests. When combined with cyanuric acid, which may also be present in melamine powder, melamine can form crystals that can give rise to kidney stones.

These small crystals can also block the small tubes in the kidney potentially stopping the production of urine, causing kidney failure and, in some cases, death. Melamine has also been shown to have carcinogenic effects in animals in certain circumstances, but there is insufficient evidence to make a judgment on carcinogenic risk in humans.

What are the symptoms and signs of melamine poisoning?

Irritability, blood in urine, little or no urine, signs of kidney infection, high blood pressure

What is the treatment for kidney stones and kidney failure?

Patients may receive various types of treatment, depending on the severity of the kidney effects. Treatment may include infusion of fluids and urine alkalinisation, correction of electrolyte and acid-base disturbance, haemodialysis or peritoneal dialysis, or surgical removal of kidney stones.

Radiology & Children: Extra Care Required

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com August 1^st, 2008

* Kids May Be More Sensitive

* First Focus: Computed Tomography (CT)

* CT: Tips for Parents

Most everyone knows of the need for safety when having radiological imaging, such as X-rays, done. Steps to protect against the low-level radiation involved with these procedures include the wearing of lead aprons and the extra precautions required for imaging pregnant women.

Additional vigilance and safety are also needed when it comes to the radiological imaging of children.

Kids May Be More Sensitive

The individual risk from radiological imaging is quite small when compared to the benefits that it can provide through helping with accurate diagnosis. Still, unnecessary radiation exposure during medical procedures should be avoided. This is particularly important when the patient is a child.

Children may be more sensitive to radiation received from medical imaging scans than adults. One factor to consider is that children have more rapidly dividing cells that can be exposed to the low-level radiation. Also, they have a longer expected lifetime for the effects of radiation exposure to manifest as cancer.

That is why it is important that with children, the lowest radiation dose necessary is used for providing an image from which an accurate diagnosis can be made.

FDA's Center for Devices and Radiological Health (CDRH) regulates medical imaging devices. Among its many responsibilities is helping consumers keep informed about minimizing unnecessary radiation exposure in medical procedures.

This emphasis on information is why the agency is assisting Image Gently, a national initiative of the Alliance for Radiation Safety in Pediatric Imaging. Image Gently aims to educate parents and health care professionals about the special precautions required for children undergoing radiological imaging.

Participants in the Image Gently campaign include the Society for Pediatric Radiology, the American College of Radiology, the American Society of Radiologic Technologists, and the American Association of Physicists in Medicine. FDA has included links to Image Gently on CDRH Web pages, helping the initiative get its message out.

First Focus: Computed Tomography (CT)

The campaign's introductory focus is on child-safety awareness in regard to computed tomography (CT) scans.

CT scans are taken in large machines containing a round hole and tunnel chamber. Patients lie on a table that slides into the chamber, where an X-ray camera rotates around them and snaps pictures offering health care professionals three-dimensional views of internal organs, bone, soft tissue, and blood vessels.

CT has helped improve the diagnosis and care for conditions such as cancer, heart disease, brain disorders, and cardiovascular illnesses. But the technology does expose patients to higher doses of radiation than most other radiological exams.

FDA has long been involved in notifying the public and health care professionals about reducing radiation risk from CT for pediatric and small adult patients.

The agency has advised radiology professionals to optimize CT settings based on patient weight or diameter and the part of the body of interest, reduce dose while maintaining diagnostic image quality, reduce the number of multiple scans with contrast material, and eliminate inappropriate patient referrals for CT.

CT: Tips for Parents

Meanwhile, the Image Gently campaign advises parents to:

--Talk with your child's physician. He or she will know or can find out if the imaging center to which they refer uses appropriate pediatric CT scanning techniques, and if a non-radiation imaging test might be as useful for your child's situation.

--Be your child's advocate. Learn about ways health care professionals can lower and limit radiation dose in the CT imaging of children without compromising diagnostic quality. Ask questions.

--Be sure that the imaging facility is using appropriate reduced radiation techniques. You may not know unless you ask, and it is reasonable and within your rights to do so.

Check credentials. Ask whether the facility has American College of Radiology accreditation, whether the CT technologists have the proper credentials, and if the person interpreting the studies is a board-certified radiologist or pediatric radiologist.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

Image Gently Web page

www.pedrad.org/associations/5364/ig/index.cfm?page=392

FDA: What are the Radiation Risks from CT?

www.fda.gov/cdrh/ct/risks.html

FDA Fact Sheet: Whole-Body Computer Tomography (CT) Imaging

www.fda.gov/womens/getthefacts/ct.html

Devices That Keep the Heart Beating

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com July 1^st, 2008

The article covers the following topics:

* Recent Actions and Approvals

* Types of Heart Devices

* Reporting Problems

Heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. FDA approvals and oversight have made scientific and technological breakthroughs accessible, greatly expanding the number of people who can benefit from these devices. FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of all medical devices, including heart devices, sold in the United States.

 Recent Actions and Approvals

Recent FDA actions and approvals related to heart devices include:

-Approval of the first compact heart assist device. In April 2008, FDA approved the first device to support the weakened heart of a small-sized adult man or woman who is at risk of dying while awaiting a heart transplant. Previous models of these surgically implanted mechanical pumps were too large to be placed in the upper abdomen of some people.

Comprehensive review of drug coated stents to address concerns about their safety. FDA has concluded that these stents are safe and effective when used within their labeled indication.

-Approval of the first totally implanted permanent artificial heart for humanitarian uses. The device is for patients with advanced heart failure involving both of the organ's pumping chambers, who are not eligible for a heart transplant, and who are unlikely to live more than a month without intervention.

-Approval of pacemakers that reduce severe heart failure symptoms by resynchronizing the pumping action of both heart chambers.

-Approval of new monitoring devices that allow implantable cardioverter defibrillators (ICDs) to transmit basic information about the patient and the device to physicians between office visits.

Types of Heart Devices

Through its "Heart Health Online" Web page at www.fda.gov/hearthealth/index.html , FDA offers consumers extensive information about a variety of heart devices.

These devices include:

Automated External Defibrillators (AEDs): Portable and automatic, these devices help restore normal heart rhythm to patients in cardiac arrest. They analyze heart rhythm and can help rescuers determine whether a shock is needed to restore a normal heartbeat.

Cardiac Ablation Catheters: Long, thin flexible tubes that are threaded into or onto the heart, cardiac ablation catheters treat abnormally rapid heartbeats that cannot be controlled with lifestyle changes or medications. They work by modifying small areas of heart tissue that are causing abnormal heart rhythms.

Cardiac Angioplasty Devices: These are long, thin, flexible tubes that are threaded into a heart blood vessel to open narrowed or blocked areas. They improve blood flow to the heart, reduce chest pain, and treat heart attacks.

Cardiac Pacemakers: Small and battery-powered, pacemakers are implanted permanently into the body. Used when the heart beats too slowly or has other abnormal rhythms, they monitor the organ's electrical impulses and, when needed, deliver electrical stimuli to make it contract in a more normal tempo.

Implantable Cardioverter Defibrillators (ICDs): These monitor heart rhythms and deliver shocks if dangerous rhythms are detected. Many record the heart's electrical patterns whenever an abnormal heartbeat occurs, allowing doctors to review the patterns. New monitoring devices allow ICDs to transmit basic information to physicians.

Prosthetic (Artificial) Heart Valves: Used for replacing diseased or dysfunctional heart valves, these are available in two forms. Mechanical valves are made of man-made materials and can usually last a lifetime. Biological valves are made from tissue taken from animals or human cadavers.

Stents: Small, lattice-shaped, metal tubes that are inserted permanently into an artery, stents help improve blood flow. Some contain drugs that reduce the chance that arteries will become blocked again.

Ventricular Assist Devices (VADs): Mechanical pumps that help weak hearts pump blood adequately, VADs were originally intended for short-term use until donor hearts became available. Some are now used for long-term therapy in patients with severe heart failure who are not candidates for heart transplants.

Reporting Problems

If you're having problems with your heart device, or any other medical device, contact MedWatch, FDA's program for reporting serious reactions, product quality problems and product use errors regarding medical products. MedWatch can be found at www.fda.gov/medwatch/report/consumer/consumer.htm

Consumers can also call FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) for information about medical products.

For More Information

FDA Approves First Compact Heart Assist Device

www.fda.gov/bbs/topics/NEWS/2008/NEW01820.html   

Heart Health Online (FDA)

www.fda.gov/hearthealth/index.html

Recently Approved Devices

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1

Home Healthcare Medical Devices—A Checklist

www.fda.gov/cdrh/CDRHHHC/brochure-checklist.html

e-published on MedicineandBiotech.com June 1^st, 2008

* Understanding Cholesterol

*Cholesterol Numbers That Matter

* What Affects Cholesterol?

* State of the Statins

* Tips for Consumers

When it comes to keeping your heart healthy, what foods you eat and the genes you inherit matter. Good heart health also may depend on the drugs you take. Several medicines are effective at lowering blood cholesterol levels—a key factor in good heart health. Chief among them are the statins.

Statins (HMG-CoA reductase inhibitors) are one class of many drugs used to lower the level of cholesterol in the blood by reducing the production of cholesterol by the liver. Statins block the enzyme in the liver that is responsible for making cholesterol. Too much cholesterol can increase a person's chance of getting heart disease. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both women and men in the United States.

Understanding Cholesterol

Cholesterol is a waxy substance found in all parts of the body. It is critical to the normal function of all cells. The body needs cholesterol for making hormones, digesting dietary fats, building cell walls, and other important processes. Your body makes all the cholesterol it needs, but cholesterol is also in some of the foods you eat.

When there is too much cholesterol in your blood, it can build up on the walls of the arteries (blood vessels that carry blood from the heart to other parts of the body). This buildup is called plaque. Over time, plaques can cause narrowing or hardening of the arteries—a condition called atherosclerosis. In short, too much cholesterol can clog your arteries and keep your heart from getting the blood it needs.

Cholesterol Numbers That Matter

There are no warning symptoms of high cholesterol. But a simple blood test by your doctor will measure the different kinds of cholesterol.

Low-density lipoprotein (LDL) or "bad" cholesterol can clog the arteries. Lower numbers of LDL are best. The higher the LDL level, the greater the risk for heart disease.

High-density lipoprotein (HDL) or "good" cholesterol carries bad cholesterol out of your blood, back to the liver, where it can be eliminated, to keep it from building up in the arteries. The higher the HDL level, the lower the risk for heart disease.

For information on what your cholesterol numbers mean, visit www.nhlbi.nih.gov/health/public/heart/chol/wyntk.htm#numbers

What Affects Cholesterol?

 The following factors affect blood cholesterol levels:

-Certain foods - eating too much saturated fat, found mostly in animal products, and too much cholesterol, found only in animal products

-Heredity - genes play a role in influencing the levels

-Weight - excess weight tends to increase the levels

-Exercise - regular physical activity may not only lower LDL cholesterol, but it may increase the level of desirable HDL cholesterol

-Smoking - cigarette smoking lowers HDL cholesterol

-Age and gender - cholesterol levels naturally rise as men and women age. Menopause is often associated with increased LDL cholesterol in women.

State of the Statins

The main goal of cholesterol treatment is to lower LDL to levels that will not lead to or worsen heart disease. When a patient without heart disease is first diagnosed with elevated blood cholesterol, the National Cholesterol Education Program guidelines advise a six-month program of reduced dietary saturated fat and cholesterol, together with physical activity and weight control, as the primary treatment to bring levels down.

When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe medication—the most prominent being the statins. By interfering with the production of cholesterol, statin medications can slow the formation of plaques in the arteries.

Statins are relatively safe for most people, but some can respond differently to the drugs. Certain people may have fewer side effects with one statin drug than another. Some statins, in particular Lovastatin and Simvastatin, also are known to interact adversely with other drugs. This information, coupled with the degree of cholesterol-lowering desired, will help guide the decision about which statin to use, or whether another type of drug should be used.

Statin medications (HMG-CoA reductase inhibitors)

-work in the liver to prevent formation of cholesterol

-are effective in lowering bad cholesterol levels and raising good cholesterol

-are not recommended for pregnant patients or those with active or chronic liver disease

-can cause serious muscle problems

Currently available statins

Lovastatin (Mevacor, Altoprev)

Pravastatin (Pravachol)

Simvastatin (Zocor)

Fluvastatin (Lescol)

Atorvastatin (Lipitor)

Rosuvastatin (Crestor)

Tips for Consumers

-Have your blood cholesterol levels checked at least once every 5 years if you are an adult 20 years or older.

-Check with your doctor. You may be able to lower your cholesterol levels by eating better and exercising more.

-Maintain a healthy weight. Being overweight increases your risk for heart disease.

-Stay active every day.

-Use the food label to choose foods lower in saturated fat, including trans fats, and calories.

-Eat more fruits and vegetables.

-Don't stop taking any cholesterol-lowering medications you may be on without first talking to your doctor.

For More Information

National Heart, Lung, and Blood Institute Health Information Center

www.nhlbi.nih.gov/health/infoctr/index.htm

FDA's Center for Drug Evaluation and Research

www.fda.gov/cder/index.html

WHO World Health Day-April 7^th

-2008 Theme "Protecting Health from Climate Change"-

Climate Change: An Issue For The Health Sector

http://www.who.int/world-health-day/theme/en/index.html

World Health Day marks the founding of WHO. It is the Organization's most visible effort to raise awareness of a key global health issue selected each year. The First World Health Assembly created the event in 1948 and it has been celebrated on 7 April annually since 1950. WHO organizes international, regional and local events on the Day and throughout the year to highlight the selected priority health area.

In 2008, World Health Day is dedicated to the theme "Protecting health from climate change." The theme was selected in recognition that climate change is posing ever growing threats to global public health security.

A range of activities in every country will aim to stimulate active, long-term involvement. World Health Day 2008 offers an opportunity to revitalize political commitment to address climate change.

Aims and objectives of World Health Day 2008

 The objective of World Health Day 2008 is to catalyze public participation in the global campaign to protect health from the adverse effects of climate change. WHO aims to put public health at the centre of the UN agenda on climate change. This is an opportunity for the international agencies, nongovernmental organizations, and governments as well as WHO to:

* Establish links between climate change and health and other development areas such as environment, food, energy, transport;

* Hold events/activities in countries to publicize issues related to the impact of climate change on health;

* Involve as wide a spectrum of the world population as possible in efforts to stabilize climate change;

* Create advocacy campaigns for generating momentum that compels governments, the international community, civil society and individuals

to take action;

* Protect poor and vulnerable populations from the effects of climate change, especially in Africa.

Goals for World Health Day 2008

http://www.who.int/world-health-day/goals/en/index.html

Key messages for World Health Day 2008

http://www.who.int/world-health-day/key_messages/en/index.html

Source: WHO

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Extended Recall of Baxter’s Heparin Products and FDA’s Notice Issued to Chinese Company Changzhou SPL Implicated in Tainted Heparin

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com March 1^st, 2008

FDA Inspects the Chinese company, Changzhou SPL Company, Ltd. implicated in tainted Heparin and finds objectionable and unsatisfactory conditions and procedures and issues an FDA-483. This FDA-483 is an accurate representation of the original FDA-483 issued to the firm, it is not an exact copy.

View at http://www.fda.gov/ora/frequent/483s/Changzhouspl_heparin_20080226_483.html

Feb 28, 2008. The Food and Drug Administration is issuing this update to inform the public that  Baxter Healthcare Corporation has extended its recall of multi-dose vials of heparin sodium for injection to also include single-dose vials of heparin sodium for injection.

As a precautionary measure Baxter is also recalling its heparin lock flush products.  The heparin source manufacturer for lock flush solutions is the same as that for Baxter’s heparin sodium for injection. 

Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market.

Since FDA learned of the adverse events associated with the Baxter multi-dose heparin vials, the Drug Shortages Team at FDA has been working closely with APP, the other supplier in the US for heparin multi-dose and single-dose vials, to determine their manufacturing capacity.  With the verification that APP can now adequately supply the US market Baxter is voluntarily recalling all of its multi-dose and single-dose vials.  FDA has also confirmed that there are multiple U.S. suppliers of heparin lock flush products with substantial inventory, making a shortage of these products unlikely.

The recall notice issued by Baxter provides instructions to healthcare providers and institutions regarding the identification and disposition of their product they may have in their inventories. The only Baxter heparin-containing products that will remain on the market are large volume parenteral solutions containing 200 Units of heparin per 100 cc in 500 and 1000 cc total volume bags.  No adverse events have been reported in relation to the large volume solution.  The heparin source manufacturer for the large volume solution is different from that of the products being recalled.

On February 11, 2008, the FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation.  A description of the clinical settings and characteristics of the cases of serious adverse events that resulted in the public health advisory can be found at http://www.fda.gov/cder/drug/advisory/heparin.htm.

The underlying cause of adverse events reported for Baxter’s heparin sodium is still unknown and remains under investigation.   FDA investigators and scientists are working independently and in collaboration with the Centers for Disease Control and Prevention, and Baxter to discover the underlying cause of the adverse events. 

FDA continues to monitor its post-marketing safety database for additional cases in the US and abroad related to heparin usage.  Health care providers are encouraged to report all allergic-type reactions to any heparin infusion to FDA’s MedWatch on line at http://www.fda.gov/medwatch/report/hcp.htm,  by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088.

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com Feb 1^st, 2008

Read Report: Animal Cloning: A Risk Assessment http://www.fda.gov/cvm/CloneRiskAssessment_Final.htm

Read Report: Animal Cloning-Risk Management Plan for Clones and Their Progeny http://www.fda.gov/cvm/CloningRA_RiskMngt.htm

Read: Guidance for Industry Use of Animal Clones and Clone Progeny for Human Food and Animal Feed http://www.fda.gov/cvm/Guidance/Finalguideline179.htm

FDA's Response to Public Comment on the Animal Cloning Risk Assessment, Risk Management Plan, and Guidance for Industry http://www.fda.gov/cvm/CloningRA_FDAResponse.htm

After years of detailed study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine (pigs), and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. This conclusion stems from an extensive study of animal cloning and related food safety, culminating in the release of three FDA documents in January 2008: a risk assessment, a risk management plan, and guidance for industry.

Researchers have been cloning livestock species since 1996, starting with the famous sheep named Dolly. When it became apparent in 2001 that cloning could become a commercial venture to help improve the quality of herds, FDA's Center for Veterinary Medicine (CVM) asked livestock producers to voluntarily keep food from clones and their offspring out of the food chain until CVM could further evaluate the issue.

FDA Studies Cloning

For more than five years, CVM scientists studied hundreds of published reports and other detailed information on clones of livestock animals to evaluate the safety of food from these animals. The resulting report, called a risk assessment, presents FDA's conclusions thatcloning poses no unique risks to animal health, compared to the risks found with other reproduction methods, including natural mating  the composition of food products from cattle, swine, and goat clones, or the offspring of any animal clones, is no different from that of conventionally bred animals  because of the preceding two conclusions, there are no additional risks to people eating food from cattle, swine, and goat clones or the offspring of any animal clones traditionally consumed as food  FDA issued the risk assessment, the risk management plan, and guidance for industry in draft form for public comment in December 2006. Since that time, FDA has updated the risk assessment to reflect new scientific information that reinforces the food safety conclusions of the draft.

"Our additional review only serves to strengthen our conclusions on food safety," says Stephen F. Sundlof, D.V.M., Ph.D., Director of FDA's Center for Food Safety and Applied Nutrition. "Meat and milk from cow, pig, and goat clones, and the offspring of any animal clones, are as safe as food we eat every day."

FDA's concern about animal health prompted the agency to develop a risk management plan to decrease any risks to animals involved in cloning. FDA also issued guidance to clone producers and the livestock industry on using clones and their offspring for human food and animal feed.

What Is a Clone?

"Clones are genetic copies of an animal," says Larisa Rudenko, Ph.D., a Molecular Biologist and Senior Adviser for biotechnology in CVM. "They're similar to identical twins, but born at different times." Cloning can be thought of as an extension of the assisted reproductive technologies that livestock breeders have been using for centuries, such as artificial insemination, and more recently, embryo transfer and in vitro fertilization.

Animal cloning has been around for more than 20 years. Most cloning today uses a process called somatic cell nuclear transfer:

-Scientists take an egg from a female animal (often from ovaries at the slaughterhouse) and remove the gene-containing nucleus.

-The nucleus of a cell from an animal the breeder wishes to copy is added to the egg.

-After other steps in the laboratory take place, the egg cell begins to form into an embryo.

-The embryo is implanted in the uterus of a surrogate dam (female parent), which carries it to term and delivers it like her own offspring.

-Clones may allow farmers to upgrade the quality of their herds by providing more copies of their best animals—those with naturally occurring desirable traits, such as resistance to disease, high milk production, or quality meat production. These animal clones are then used for conventional breeding, and their sexually reproduced offspring become the food-producing animals.

What Cloning Means to Consumers

FDA has concluded that cattle, swine, and goat clones, and the offspring of any animal clones traditionally consumed as food, are safe for human and animal consumption.

Food labels do not have to state that food is from animal clones or their offspring. FDA has found no science-based reason to require labels to distinguish between products from clones and products from conventionally produced animals.

The main use of clones is to produce breeding stock, not food. These animal clones—copies of the best animals in the herd—are then used for conventional breeding, and the sexually reproduced offspring of the animal clones become the food-producing animals.

Due to the lack of information on clone species other than cow, goat, and pig (for example, sheep), FDA recommends that other clone species do not enter the human food supply.

For More Information

www.FDA.gov/cvm/cloning.htm

In this photo essay, WHO presents a selection of notable health issues in 2007 and years to come.

http://www.who.int/features/2007/year_review/photo_story/en/index9.html 

The continued looming threat of an influenza pandemic, outbreaks of Ebola, Marburg and other infectious diseases, natural disasters, and high rates of women who die in pregnancy and childbirth in developing countries, are topics that mark 2007.

Positively - public and private partners came together to improve global health with notable results. Progress was made to halt resurging yellow fever in Africa; the International Health Regulations came into effect that give the world clear guidance on reporting and responding to cross-border health dangers; and efforts to wipe out the last bastions of polio and to stop tuberculosis advanced.

Landmarks, such as major success in the fight to cut measles deaths in Africa, and the release of a more accurate profile of the HIV epidemic, captured news headlines as well.

 Avian influenza and pandemic preparedness

Avian influenza continued as a threat in several countries this year. Cumulative figures show a human toll of more than 200 deaths in Asia, Africa, the eastern Mediterranean and Europe since December 2003. The world needs to be prepared for a potential influenza pandemic, say experts, with special attention to influenza viruses that come from the animal world such as H5N1. The good news is that countries are now more prepared than ever for such an emergency. For example, projected supplies for an influenza vaccine in the wake of a pandemic rose sharply this year, to 4.5 billion courses by 2010.

Outbreaks: Ebola and Marburg fevers

Ebola, and Marburg - two lethal, and rare hemorrhagic fevers - caused illness and death in central Africa this year. The Democratic Republic of the Congo detected and stopped an Ebola outbreak. And both Marburg and Ebola outbreaks occurred in Uganda. WHO and its network of experts supported intensive surveillance and control measures for both illnesses. Investigative work to pinpoint the suspected source of Marburg fever - sick bats in a mine shaft where people worked - helped to increase understanding of the emerging disease.

Health action in crises

An earthquake in Peru, flooding in west Africa, a massive cyclone in Bangladesh, and the displacement of Iraqi people moving away from conflict at home created public health challenges around the world this year. WHO and its international Health Action in Crises teams responded with on-site assistance, technical help and supplies to minimize health risks and protect the well-being of affected people.

Maternal death rates falling too slowly

A serious public health challenge was reconfirmed this year: estimates released by WHO and partners in October showed that maternal death rates are falling too slowly in developing countries. The global maternal mortality ratio - which compares maternal deaths to live births - fell less than 1% annually from 1990 to 2005. This compares to a required 5.5% annual decline to meet the United Nations target to reduce maternal deaths by three quarters before 2015. Eastern Asia came closest to the target with a more than 4% annual decline. On the positive side, partners rallied in London, United Kingdom at the "Women Deliver" conference, where more than 1800 participants from 109 countries came together to pledge renewed efforts to reduce maternal deaths.

Yellow fever initiative

Global health partners mobilized this year to contain resurging cases of yellow fever in Africa through a massive vaccination campaign. This is targeted at people at risk in the world's 12 highest-burden countries, all of which are in west Africa. The Yellow Fever Initiative, backed by the GAVI Alliance and WHO, breaks new ground by swiftly immunizing people of all ages at risk for the deadly disease, quickly reducing the potential for outbreaks that could threaten the region, or spread worldwide.

International Health Regulations

Global health security advanced in June when revised International Health Regulations came into effect. The regulations give countries clear and tested guidelines for reporting disease outbreaks and public health events to WHO, triggering response systems to isolate and contain threats. In the globalized world, viruses and bacteria can spread far and wide via international travel. A health crisis in one country can impact livelihoods and trade in another. Timely and open reporting of health dangers will help make the world more secure.

Polio eradication progress

Following intensive work this year, cases of type 1 polio - the type that is more paralytic and prone to spread - are down by 80% in 2007 compared to the same time in 2006. Each of the four remaining endemic countries - Afghanistan, India, Nigeria and Pakistan - is making progress against the disease. Afghanistan and Pakistan, with WHO and partners, waged repeated, synchronized attacks on the virus: in April alone, 40 million children were vaccinated over five days in both countries. Despite significant new contributions to the campaign, an additional US$ 265 million is needed through 2008.

Stop tuberculosis: bottom-line benefits

Evidence on the economic benefits of tuberculosis (TB) diagnosis and treatment was reported by the World Bank, WHO and the Stop TB Partnership in December. Forecasters said that therapy would more than pay for itself in the worst-hit countries, when the financial impact of TB illnesses is compared to the costs of diagnosis and treatment. The good news follows the WHO Global Tuberculosis Control Report in March that found the percentage of the world's population struck by TB levelling off. A strong link between HIV/AIDS and deaths from TB and drug-resistant strains of TB is a key barrier to further progress.

Measles rates plunge, children gain

Measles deaths in Africa fell by 91% between 2000 and 2006 following mass vaccinations of children during the period, reported WHO and other partners of the Measles Initiative. The spectacular public health gains translated into a 68% decline of measles deaths worldwide. The next focus is on countries in South Asia, which now have the highest rates of measles deaths.

HIV/AIDS estimates revised

More accurate data on global HIV rates - determined through more precise country-level assessments and improved methodology - were released in November. Figures show a leveling off of the percentage of people worldwide living with HIV and a drop in new infection rates. The new data also draws attention to hot spots: eight countries in Africa now account for almost one third of new infections and AIDS deaths globally.

e-published on MedicineandBiotech.com November 1^st, 2007

---Effort will streamline generic drug approval process; provide more options for consumers, health professionals---

VIEW VIDEO

October 2007. The U.S. Food and Drug Administration has outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.

The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.“To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007.”

As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.

FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and Webcasts.

Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.

For more information:

Generic Initiative for Value and Efficiency (GIVE)

www.fda.gov/oc/initiatives/advance/generics.html 

New Initiative to Improve Availability of Generics

http://www.fda.gov/consumer/updates/generics100407.html 

Consumer Q and A: FDA's New Generic Drug Program

www.fda.gov/consumer/updates/genericsqa100407.html

FDA's Office of Generic Drugs

www.fda.gov/cder/ogd/

with Sharon Hertz, M.D., Deputy Director of FDA's Division of Anesthesia, Analgesia, and Rheumatology Products

Credit: FDA Consumer Health Information

e-published on MedicineandBiotech.com October 1^st, 2007

Sharon Hertz is Deputy Director of FDA's Division of Anesthesia, Analgesia, and Rheumatology Products and has been with FDA for 8 years. Dr. Hertz graduated from SUNY Upstate Medical Center in Syracuse, N.Y., and completed her residency in neurology at SUNY Health Sciences Center at Brooklyn.

Q. What are non-steroidal anti-inflammatory drugs (NSAIDs)?
A. NSAIDs are a group of drugs used to temporarily relieve pain and inflammation. They work by blocking the production of prostaglandins, or chemicals believed to be associated with pain and inflammation.

Q. What conditions do NSAIDs treat?
A. Prescription NSAIDs are an important treatment for many debilitating conditions such as osteoarthritis and rheumatoid arthritis. Some prescription NSAIDs also are used to treat pain. Over-the-counter versions of some NSAIDs are used to treat fever and pain associated with dental problems, tendonitis, strains, sprains and other injuries. NSAIDs are also commonly used to relieve pain associated with menstrual cramps.

Q. What are non-selective NSAIDs and COX-2 selective NSAIDs?
A. Non-selective NSAIDs work by inhibiting two enzymes that are involved with inflammation—cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2).

There are several non-selective NSAIDs on the market, including diclofenac, ibuprofen, ketoprofen, meloxicam, naproxen, and oxaprozin. Ibuprofen, ketoprofen, and naproxen are available in both prescription and over-the-counter (OTC) versions. The doses in OTC NSAIDs are lower than the doses of prescription versions and should only be used for up to 10 days without seeing a doctor. So, if you take OTC ibuprofen (Advil and Motrin) or naproxen (Aleve), the doses are about half the doses of prescription versions.

COX-2 selective inhibitors are a newer type of medicine that primarily block the COX-2 enzyme. The only COX-2 selective inhibitor currently on the market in the United States is the prescription drug Celebrex (celecoxib), which is marketed by Pfizer. It was believed that COX-2 inhibitors may be less likely to cause the stomach problems associated with the older NSAIDs, but all NSAIDs carry the risk of stomach problems.

Q. What are the risks of taking NSAIDs?
A. Like all drugs, there is the potential for an allergic reaction to NSAIDs. Symptoms may include hives, facial swelling, wheezing, and skin rash.

There is the potential for gastrointestinal bleeding associated with all NSAIDs. The risk of bleeding is low for people who use NSAIDs intermittently. The risk of stomach problems goes up for people who take them every day or regularly, especially for people who are over 65, people with a history of stomach ulcers, and people who take blood thinners or corticosteroids (prednisone). Alcohol use can also increase the risk of stomach problems.

Long-term continuous use of all NSAIDs, except for aspirin, may increase the risk of heart attack or stroke. Aspirin is a non-selective NSAID, but it has been shown in clinical trials to reduce the risks of cardiovascular events. Aspirin is sold in generic forms and under brand names such as Bayer and St. Joseph's. All NSAIDs also carry the risk of potential skin reactions. Patients should be alert for symptoms such as the skin reddening, rash, or blisters.

Q. Which people are at highest risk for cardiovascular adverse events associated with NSAIDs?
A. People who have coronary artery disease (known angina or who have had a heart attack), people who have high blood pressure, and people who have had a stroke are at the greatest risk. Also, people who have just had cardiovascular bypass surgery are at risk for heart attacks with use of NSAIDs.

Q. Which Cox-2 selective inhibitors have been taken off the market?
A. Merck voluntarily withdrew Vioxx (rofecoxib) in 2004 after finding out the results of a study that showed patients who took Vioxx had a higher risk for heart attacks than patients who took a placebo. FDA asked Pfizer to withdraw Bextra (valdecoxib) from the market in 2005 because the overall risk/benefit profile was unfavorable. The request was based on many factors. Along with the other risks associated with NSAIDs, there were a higher than expected number of reports of serious and potentially life-threatening skin reactions, including death.

An increased risk of cardiovascular adverse events has been shown for all COX-2 inhibitors, including Celebrex, which is still on the market in the United States. Based on available data, FDA determined that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients. FDA asked Pfizer to include a boxed warning on the Celebrex label, and asked manufacturers of all prescription NSAIDs to revise their labeling too. The boxed warning highlights the potential for increased risk of cardiovascular events as well as serious, potentially life-threatening gastrointestinal bleeding. It is important to know that FDA also determined that the risk for cardiovascular events was most likely present for the non-selective NSAIDs as well, and all of the manufacturers of these drugs were asked to add important warnings to their labels.

Q. What can consumers do to lower their risks with NSAIDs?
A. Tell your doctor about your complete medical history, including any history of cardiovascular disease or stomach ulcers. This will help you and your doctor weigh the risks and benefits. You can also ask your doctor what you can do to lesson the chance for stomach irritation such as taking medication with a meal. Also, ask what steps you can take to lower the risk of cardiovascular disease and report medication side effects to your doctor. Whether you're taking a prescription NSAID or an OTC NSAID, following directions is important. Available scientific data don't suggest an increased risk of serious cardiovascular events for short-term, low-dose use of OTC NSAIDs. But be aware that the OTC labeling states that if you take an NSAID for longer than 10 days, you should see your doctor. The lowest effective dose should be used for the shortest time.

e-published on MedicineandBiotech.com September 1^st, 2007

This article covers the following topics:

* Steps to Take When You Vaccinate

* Commonly Used Vaccines - Diphtheria, Tetanus, Pertussis (DTaP), Haemophilus influenzae type b (Hib) vaccine,  Hepatitis A Vaccine, Hepatitis B Vaccine, Human Papillomavirus (HPV) Vaccine, Influenza (Flu) Vaccine—Inactivated Shot, Influenza (Flu) Vaccine—Live Intranasal, Measles, Mumps, Rubella (MMR) Vaccine, Meningococcal Disease Vaccine, Pneumococcal Conjugate Vaccine,  Pneumococcal Vaccine Polyvalent, Polio Vaccine, Rotavirus Vaccine, Varicella (Chicken Pox) Vaccine.

  Vaccines have contributed to a significant reduction in many childhood diseases, such as diphtheria, polio, measles, and whooping cough. It is now rare for American children to experience the devastating effects of these illnesses. Infant deaths due to childhood diseases have nearly disappeared in the United States and other countries with high vaccination coverage. But the germs that cause vaccine-preventable diseases and death still exist, and can be passed on to people who are not protected by vaccines. Ensuring the safety and effectiveness of vaccines is one of the Food and Drug Administration's top priorities. Vaccines are developed in accordance with the highest safety standards; they must be safe to give to as many people as possible.

Like any medicine, vaccination has benefits and risks, and no vaccine is 100% effective in preventing disease. Most side effects of vaccines are usually minor and short-lived. A child may feel soreness at the injection site or experience a low-grade fever. Serious vaccine reactions are extremely rare, but they can happen. For example, signs of severe allergic reaction can include swelling, itching, weakness, dizziness, and difficulty breathing.

"But parents should also know that the risk of being harmed by a vaccine is much smaller than the risk of serious illness that comes with infectious diseases," says Norman Baylor, Ph.D., Director of the Office of Vaccine Research and Review in FDA's Center for Biologics Evaluation and Research (CBER). "Vaccination is an important step to get children off to a healthy start."

Vaccines may contain live, attenuated (but weakened) or killed (inactivated) forms of disease-causing bacteria or viruses, or components of these microorganisms. They trigger a response by the body's immune system when injected or given by mouth. Vaccines stimulate the body to make antibodies—proteins that specifically recognize and target the disease-causing bacteria and viruses, and help eliminate them from the body.

CBER is the part of FDA that regulates vaccines in the United States. CBER works with other agencies to study and monitor vaccine safety and effectiveness.

Steps to Take When You Vaccinate

Review the vaccine information sheets. These sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Health practitioners are required by law to provide them.

Talk to your doctor about the benefits and risks of vaccines. Learn the facts about the benefits and risks, along with the potential consequences of not vaccinating against certain diseases. Some parents are surprised to learn that children can die of measles, chicken pox, and other vaccine-preventable diseases.

Tell your doctor about bad reactions. Before your child receives a vaccine, tell your doctor if you, your child, or a sibling has ever had a bad reaction to a vaccine. If your child or a sibling has had an allergic reaction or other severe reaction to a dose of vaccine, talk with your health care provider about whether that vaccine should be taken again.

Ask about conditions under which your child should not be vaccinated. This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components. For example, eggs are used to grow influenza (flu) vaccines, so a child who is allergic to eggs should not get a flu vaccine.

Report adverse reactions. Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the Centers for Disease Control and Prevention. For a copy of the vaccine reporting form, call 1-800-822-7967, or report online to www.vaers.hhs.gov

Commonly Used Vaccines

Diphtheria, Tetanus, Pertussis (DTaP)

What it's for: Protects against the bacterial infections diphtheria, tetanus (Lockjaw), and pertussis (whooping cough). Tripedia, Infanrix and DAPTACEL are licensed for children 6 weeks to 7 years old. Diphtheria can infect the throat, causing a thick covering that can lead to problems with breathing, paralysis, or heart failure. Tetanus can cause painful tightening of the muscles, seizures, and paralysis. Whooping cough causes severe coughing spells and can lead to pneumonia, seizures, brain damage, and death.

Common side effects: Mild fever, redness, soreness or swelling at the injection site, fussiness or crying more than usual.

Tell your health care provider beforehand if: Your child is moderately or severely ill, or has had a severe reaction to a previous shot or has a known sensitivity to ingredients of the vaccine, including latex, which is used for the stopper vial.

Tetanus, Diphtheria, Pertussis (Tdap) Vaccine

What it's for: Boostrix is licensed for use for people ages 10 to 18 years. Adacel is licensed for people ages 11 years and older, up to age 64. Protects against the bacterial infections diphtheria, tetanus (Lockjaw), and pertussis (whooping cough).

Common side effects: Mild fever, pain and redness at injection site, headache, tiredness.

Tell your health care provider beforehand if: Your child has had any allergic reaction to any vaccine that protects against diphtheria, tetanus, or pertussis diseases, any ingredient contained in the vaccine, or to latex.

Haemophilus influenzae type b (Hib) vaccine

What it's for: Protects against Hib disease, which can cause meningitis (an infection of the covering of the brain and spinal cord), pneumonia (lung infection), severe swelling of the throat, and infections of the blood, joints, bones, and covering of the heart. Approved for children who are at least 2 months old.

Common side effects: Redness, warmth or swelling at site of injection, fever.

Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had a life-threatening allergic reaction to a previous dose of Hib vaccine.

Hepatitis A Vaccine

What it's for: Protects against liver disease caused by the hepatitis A virus. Hepatitis A can cause mild "flu-like" illness, jaundice (yellow skin or eyes), severe stomach pains, and diarrhea. A person who has hepatitis A can easily pass the disease to others within the same household. Havrix and VAQTA are licensed for use in children ages 12 months and up.

Common side effects: Soreness at the injection site, headache, loss of appetite, tiredness.

Tell your health care provider beforehand if: Your child has ever had a severe allergic reaction to a previous dose of the vaccine.

Hepatitis B Vaccine

What it's for: Protects against liver disease caused by the Hepatitis B virus. Hepatitis B can lead to liver damage, liver cancer and death. Recombivax HB and Engerix-B are licensed for use in babies at birth.

Common side effects: Soreness at injection site and fever.

Tell your health care provider beforehand if: Your child is moderately or severely ill or has ever had a life-threatening allergic reaction to baker's yeast used for making bread, or to a previous dose of the vaccine.

Human Papillomavirus (HPV) Vaccine

What it's for: Gardasil is licensed for the prevention of cervical cancer, abnormal and precancerous cervical lesions, abnormal and precancerous vaginal and vulvar lesions, and genital warts in females ages 9 to 26.

Common side effects: Pain, redness or swelling, itching at the site of injection, dizziness, fainting. Tell your health care provider beforehand if: Your child has had an allergic reaction to yeast or another component of HPV vaccine, or to a previous dose of the vaccine.

Influenza (Flu) Vaccine—Inactivated Shot

What it's for: Protects children six months and older against the influenza virus strains contained in the vaccine. Influenza is a contagious respiratory illness caused by the influenza virus. It can cause mild to severe illness, and at times can lead to death. The influenza viruses that cause disease in people may change every year, so yearly vaccination is needed to reduce the chances of getting sick.

Common side effects: Soreness at the injection site, low-grade fever, and aches. The influenza vaccine is made from killed or inactivated influenza viruses, so your child can't get the flu from the flu shot.

Tell your health care provider beforehand if: Your child is moderately or severely ill, has ever had an allergic reaction to eggs or to a previous dose of the flu vaccine, or has ever had Gullian-Barre Syndrome (GBS), a serious neurological disorder that can occur either spontaneously or after certain infections. The disorder typically involves weakness in the legs and arms that can be severe.

Influenza (Flu) Vaccine—Live Intranasal

What it's for: FluMist is sprayed into both nostrils and protects against flu in healthy children and adolescents ages 5 to 17.

Common side effects: Runny nose, headache, vomiting, muscle aches, low-grade fever. This vaccine, which contains weakened viruses, usually doesn't cause illness, because the viruses have lost their disease-causing properties.

Tell your health care provider beforehand if: Your child is pregnant, moderately or severely ill, has a weakened immune system, has ever had an allergic reaction to eggs or to a previous dose of the flu vaccine, has a history of asthma or any other history of coughing, wheezing, or shortness of breath, or has a history of Gullian-Barre Syndrome (GBS).

Measles, Mumps, Rubella (MMR) Vaccine

What it's for: Protects against measles, mumps, and rubella in children ages 12 months and up. Measles is a respiratory infection that causes skin rash and flu-like symptoms. It can cause severe disease leading to ear infection, pneumonia, seizures, and brain damage. Mumps causes fever, headache and swollen glands, especially salivary glands. It can also lead to deafness, meningitis (infection of the brain and spinal cord covering), painful swelling of the testicles or ovaries. Rubella, also called German Measles, is an infection of the skin and lymph nodes and can cause arthritis. Rubella infection during pregnancy can lead to birth defects.

Common side effects: Fever and mild rash. In rare cases, swelling of the glands in the cheeks or neck.

Tell your health care provider beforehand if: Your child is ill or has ever had an allergic reaction to gelatin, the antibiotic neomycin, or a previous dose of the MMR vaccine.

Meningococcal Disease Vaccine

What it's for: Menactra is licensed for use in people ages 11 years and older, up to age 55. Menomune is licensed for use in children 2 years and older. These vaccines protect against meningococcal disease, a serious illness caused by a bacteria. It is a leading cause of bacterial meningitis in children 2-18 years old in the United States. Meningitis is an infection of fluid surrounding the brain and the spinal cord.

Common side effects: Sore arm, headache, fatigue.

Tell your health care provider beforehand if: Your child has had a severe allergic reaction to a previous dose of meningococcal vaccine, has a known sensitivity to vaccine components or latex, which is used in the vial stopper, or has bleeding disorders or a history of Gullian-Barre Syndrome (GBS), a serious neurological disorder that can occur either spontaneously or after certain infections. The disorder typically involves weakness in the legs and arms that can be severe.

Pneumococcal Conjugate Vaccine

What it's for: Prevnar (Pneumococcal 7-valent Conjugate Vaccine) protects infants and toddlers against serious pneumococcal disease, such as meningitis and blood infections, and some ear infections.

Common side effects: Redness, tenderness, swelling at injection site, fever, fussiness, drowsiness, loss of appetite.

Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had an allergic reaction to a previous dose.

Pneumococcal Vaccine Polyvalent

What it's for: Pneumovax 23 is licensed for use in children with certain health conditions who are 2 years or older for the prevention of the 23 most prevalent types of pneumococcal bacteria. Pneumococcal disease can lead to serious infections of the blood, the lungs, such as pneumonia, and the covering of the brain (meningitis).

Common side effects: Soreness, warmth, redness, swelling at the site of injection.

Tell your health care provider beforehand if: Your child is allergic to any component of the vaccine, has a respiratory illness or other active infection, or has severely compromised cardiovascular and/or pulmonary function.

Polio Vaccine

What it's for: The inactivated poliovirus vaccine (IPV) protects against the virus that causes polio, an illness that can cause paralysis or death. For children at least 2 months old.

Common side effects: Soreness at injection site, muscle aches, low-grade fever.

Tell your health care provider beforehand if: Your child has ever had a severe allergic reaction to a previous shot or an allergic reaction to the antibiotics neomycin, streptomycin, or polymyxin B.

Rotavirus Vaccine

What it's for: RotaTeq is a live vaccine given by mouth to prevent rotavirus gastroenteritis in infants. This viral infection of the stomach and intestines can cause severe diarrhea, vomiting, and fever, which may lead to serious dehydration. For children who are at least 6 weeks old, but younger than 32 weeks.

Common side effects: Mild, temporary diarrhea or vomiting.

Tell your health care provider beforehand if: Your child has a known or weakened immune system, is allergic to any of the ingredients of the vaccine, or has ever had an allergic reaction after getting a dose of the vaccine.

Varicella (Chicken Pox) Vaccine

What it's for: Varivax (varicella virus vaccine live) protects against chicken pox in people 1 year and older. Chicken pox, which is caused by the varicella-zoster virus, causes itchy blisters and fever. Complications of chicken pox can include skin infection, scarring, brain swelling, and pneumonia.

Common side effects: Soreness or swelling at the injection site, fever, mild rash.

Tell your health care provider beforehand if: Your child is moderately or severely ill, or has ever had a life-threatening allergic reaction to gelatin, the antibiotic neomycin, or a previous dose of chicken pox vaccine.

For More Information:

FDA's Web Page on Vaccines

http://www.fda.gov/cber/vaccines.htm

Immunization Schedules

http://www.cdc.gov/vaccines/recs/schedules/default.htm

Vaccines Licensed for Distribution in the United States

http://www.fda.gov/cber/vaccine/licvacc.htm

The Vaccine Adverse Event Reporting System

http://www.fda.gov/cber/vaers/vaers.htm

CDC's Web Page on Vaccines

http://www.cdc.gov/vaccines/

June 28, 2007. The Food and Drug Administration (FDA) today announced a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. FDA will start to detain these products at the border until the shipments are proven to be free of residues from drugs that are not approved in the United States for use in farm-raised aquatic animals.

This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

"We're taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA's assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards."

During targeted sampling from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States.

The contaminants were the antimicrobials nitrofuran, malachite green, gentian violet, and fluoroquinolone. Nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics.

None of these substances is approved for use in farm-raised seafood in the United States, and the use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities. Chinese officials have acknowledged that fluoroquinolones are used in Chinese aquaculture and are permitted for use in China.

The levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.

The FDA action includes conditions under which an exporter can be exempted from FDA's detention action by providing specified information to the agency. This information must demonstrate the exporter has implemented steps to ensure its products do not contain these substances and that preventive controls are in place. The additional import controls placed on seafood from China will last as long as needed.

FDA may allow the entry into the United States and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of these drugs.

Unregulated disposal of e-waste harms the environment. 

The world's annual volume of "e-waste" is expected to exceed 40m tonnes in the near future, the UN estimates.

Companies that have signed up to the scheme include Microsoft, Ericsson, Hewlett-Packard (HP) and Dell.

"The global materials flow of electronic and electrical equipment requires a global approach," explained Ruediger Kuehr, executive secretary of the UN project, called Solving the E-Waste Problem (StEP).

 HAZARDOUS WASTE

1: Lead in cathode ray tube and solder

2: Arsenic in older cathode ray tubes

5: Antimony trioxide as flame retardant

4: Polybrominated flame retardants in plastic casings, cables and circuit boards

3: Selenium in circuit boards as power supply rectifier

6: Cadmium in circuit boards and semiconductors

7: Chromium in steel as corrosion protection

8: Cobalt in steel for structure and magnetism

9: Mercury in switches and housing 

He said growth in the consumption of goods and devices around the world meant the problem would only get worse if left unchecked.

"Just look at places such as China and India; in all of these transitional countries, the demand for electrical and electronic devices is exploding," Mr Kuehr observed.

The decreasing cost of replacing computers, mobile phones and other gadgets, and the speed with which technology goes out date, has resulted in more and more devices ending up on the scrap-heap.

The European Environment Agency has calculated that the volume of e-waste is rising about three times faster than any other form of municipal waste.

If not disposed of properly, e-waste can result in toxic substances seeping in soil and groundwater, harming the local environment and people's health.

'Informal' recycling

Klaus Hieronymi, business environment manager for HP, said the initiative would address the environmental and health concerns.

Some nations have seen rapid growth in informal recycling networks 

The main problems were in developing nations in Asia, Africa and South America, where "informal" recycling networks operated, he added.

"Basically, people are going round collecting PCs, printers and fridges, and take them home into their backyard.

"They earn money by dismantling the products, salvaging parts, and removing precious metals."

But they lacked proper skills and equipment, leaving themselves and the local environment exposed to harmful substances, he warned.

"For example," Mr Hieronymi explained, "burning salvaged cables to expose copper wires, rather than using machines to cut away the casing, results in toxic fumes being emitted."

Mr Ruediger said that a team of Swiss researchers, who were part of the StEP partnership, were providing training for the recyclers.

"It is in order to make people aware of what they are doing and the impact on their environment and on their health."

Raising awareness

In industrialised nations and established markets, the initiative will focus on making consumers aware of the consequences of throwing away equipment that still works.

A growing number of people earn a living from recycling e-waste

Taskforces will help shape government policies and look at concerns surrounding products' design, life expectancy and recyclability.

And the UN initiative will build on the framework set up under the EU's Waste Electrical and Electronic Equipment (WEEE) Directive.

The directive requires producers to bear the cost of the collection, recovery and disposal of devices no longer wanted by consumers.

"It will challenge companies to improve the design and performance of their goods," Mr Ruediger predicted.

As well as involving leading manufacturers of electronic goods, the taskforces will also include academics, government officials and NGOs.

The long-term goal of the initiative is to develop a global standard for recycling, and improve the collection and recycling of e-waste.

StEP's secretariat will be hosted by the United Nations University in Bonn, Germany.

Researchers studied 66,000 women in and around 36 US cities, finding pollution levels varied between four to nearly 20 micrograms per cubic meter. The University of Washington team said each 10 microgram rise was matched by a 76% rise in the chances of dying from heart disease or stroke.

It was not clear whether women are more susceptible to pollution than men, the New England Journal of Medicine said. However, women's coronary arteries are smaller and this might render them more vulnerable. For women living within, rather than between, cities, the risk more than doubled, increasing by 128%, with each step up in pollution levels.

 Preventing these effects requires reducing the pollution at the source. All the participants were aged 50 to 79 and part of the Women's Health Initiative, a major US investigation into the causes of heart disease in women.

None of the women initially had any sign of heart disease. They were monitored for up to nine years to see which of them went on to suffer a heart attack or stroke, undergo bypass surgery, or die from cardiovascular causes.

A total of 1,816 women suffered one or more cardiovascular event. Data on the women's health were compared with air pollution readings from 36 metropolitan areas.

Scientists focused on tiny airborne particles called particulates, which are less than 2.5 microns across, and can lodge in the lungs. About 30 or 40 of the particles equal the width of a human hair.

Normally invisible, they can be seen as dense clouds as they emerge from an exhaust pipe, smokestack or chimney, and are responsible for urban haze.

It was already known that fine particulates are associated with heart disease, but earlier studies did not look at the effect of local air pollution on previously healthy individuals.

Researchers said the results suggested that for older women fine particulates are far more hazardous than was previously thought. These soot particles, which are typically created by fossil-fuel combustion in vehicles and power plants, can contain a complex mix of chemicals. The tiny particles, and the pollutant gases that travel along with them, cause harmful effects once they are breathed in.

The researchers said it was unclear precisely how fine sooty particles might trigger heart disease, but one thought was that they accelerated the hardening and narrowing of arteries. This adds to the mounting evidence that air pollution should be taken seriously as a risk factor for cardiovascular disease. When localized air pollution is particularly high, people with chronic lung disease or coronary heart disease should avoid staying outside for long periods.

Opponents say a majority of US consumers are against animal cloning.

The FDA study examined meat and milk products from cattle, pigs and goats, but not sheep. It concluded that the cloned animals produced food products virtually indistinguishable from more traditional offerings.

Cloned animals are exact genetic replicas of a donor animal. A sheep, Dolly, was the first animal successfully cloned, in 1996.

The agency suggested that the results meant it would be unlikely to recommend placing special label on food from cloned animals. A final decision on labeling would not be taken until the end of a public consultation period due to begin soon, an FDA official said. No unique risks for human food consumption were identified in cattle, swine or goat clones

A draft risk assessment by the FDA made it clear that the organization believed cloned food was safe. "No unique risks for human food consumption were identified in cattle, swine or goat clones," the reports said.  It recommended no special safeguards on food produced from cloned animals.

But consumer groups were less keen on the ruling, which could see the US become the first country to allow cloned food products into the food supply. Carol Foreman, of the Consumer Federation of America, described the ruling as potentially "a very bad decision". "We are urging people to write to the FDA, to members of Congress, to urge them to tell the FDA to back off," she told the AFP news agency.

Another group, the International Dairy Food Association, appeared cautious. "Animal cloning is a relatively new technology, and it's important that we have a thorough, deliberative dialogue," the group said in a statement.

Send us your opinions on this topic at editor@medicineandbiotech.com

Lucia Pirisi-Creek is Professor of Pathology and Microbiology at the University of South Carolina School of Medicine, Biomedical/Health Sciences Research Facilitator at the Office of Research and Health Sciences, University of South Carolina, and Interim Deputy Director of the South Carolina Cancer Center. Lucia was born in Italy almost 50 years ago, is married and is a mother of two children. She received her M.D. degree in Italy in 1983, and moved to the USA in 1985 with a NIH Fogarty Visiting Scientist Fellowship, to conduct basic cancer research at the National Cancer Institute. In 1988, she became Assistant Professor of Pathology at the USC School of Medicine. She is the author or co-author of 50 scientific publications, has mentored numerous Ph.D., Master, and Undergraduate students in research, and directs an active, extramurally-funded research program focusing on cervical cancer and its major causative agent, human papillomavirus (HPV). She is a founding member of the International Papillomavirus Society (www.ipvsoc.org) , and currently serves as the secretary and treasurer. She also spearheaded the formation of the South Carolina Multicultural Arts Center, Inc. (www.scmcac.org) of which she is President and Founding Member.

Oncogenic human papillomavirus (often referred to as high-risk HPV, or HR HPV) infection is the primary cause of cervical cancer. This cause-effect relationship has been fully established in epidemiological studies, and is supported by a wealth of information on specific activities of viral oncoproteins (E6 and E7) that de-stabilize the cellular genome, and predispose infected cells to a series of genetic and biological changes that can ultimately lead to cancerous growth. However, this cause-effect relationship has important limitations, and a simple diagnosis of HPV infection does not mean that a diagnosis of cancer is around the corner.

• HPV is a sexually transmitted virus that may cause cervical cancer.
• There are two main classes of HPV: high-risk and low-risk.
• Low-risk types of HPV usually cause genital warts, and warts do not turn into cancer.
• High-risk types of HPV are linked to cervical cancer.
• A woman may test positive for high-risk HPV and then have no signs of HPV a few months later.
• Clinicians are most concerned about women who have high-risk types of HPV that do not seem to go away.
• About 5 million people get HPV each year and about 20 million people have HPV at any given time in the U.S.
• About 12,000 women are diagnosed with cervical cancer each year in the U.S.
• It is possible for women and men to have HPV and never know they have it. It is possible to be infected and not find out for many years.
• There are no certain ways to know who infected whom.
• There is no easy way to tell if a male partner has high-risk HPV.
• There are no approved ways of testing men for high-risk HPV.
• Condoms do not always prevent the spread of HPV (however, condoms protect from other sexually-transmitted diseases)
• There is no treatment to cure HPV. Genital warts and lesions due to HPV can be removed but the viral infection is not cured.

The list above is still a daunting series of facts to many patients confronted with a diagnosis of HPV infection, and also to people in a public education setting. STDs have a negative social stigma, and "cancer" is a word that evokes deep fear and anxiety. Imagine a woman being told that she has an STD that may cause cancer! Additionally, women may fear being accused of infidelity or promiscuity if they disclose their HPV positive status to others.

All of the reasons mentioned above are a strong deterrent for doctors to discuss HPV with their patient, and constitute a deterrent to talking about HPV in educational settings as well.

1. HPV is a very common sexually transmitted infection (~20 million people). Most people who have sex will have HPV at some time in their lives, but many will never know it.
2. Some types of HPV have been shown to cause cervical cancer. However, very few women get cervical cancer, and with careful follow-up this disease can be completely avoided.
3. The best way of preventing cervical cancer is to get follow-up care for abnormal Pap test results, particularly when HPV is detected.

Epidemiological and laboratory-based studies have demonstrated quite conclusively that HPV infection, although necessary, is not sufficient to cause cancer. In fact, the development of cancer is not the most likely consequence of HPV infection, it’s a rather infrequent event. While HPV infection is very common (about 5 million people contract HPV infection in a year, and about 20 million people have HPV infection at any given time, in the USA) cervical cancer is actually quite rare, with about 12,000 new cases/year. The use of the Pap smear as a screening tool has dramatically decreased the numbers of lesions that progress to cancer in the USA. Cervical pre-cancerous lesions are detected by Pap smear and removed, before they have a chance to become cancer. In addition, many years may pass between the first infection and the manifestations of malignant disease in HPV infected women. In cell culture, HPV causes very well characterized changes that allow cells to escape senescence and become "immortalized". Immortalization is considered a first, important step in the transformation process, but HPV-immortalized cells do not produce tumors in animals, indicating that HPV by itself is not capable of fully transforming normal cells into cancer cells. The elucidation of the other factors, mechanisms, genetic changes that determine the progression of HPV-mediated lesions to cancer is a very active area of research in the epidemiology/public health arena, as well as in the laboratory and in the clinical setting. This research remains of the utmost importance for the development of more effective strategies to prevent and treat cervical cancer.

The fundamental concepts outlined above have profound consequences for our approach to HPV infection as a determinant of risk for cervical cancer in patient populations. The link between HPV and cervical cancer provides clear indications that a complete solution of the cervical cancer problem worldwide is possible, and practically within reach. In fact, anti-HPV vaccines are being developed and show considerable promise. However, we are still many years away from being able to mount global anti-HPV vaccination campaigns that will solve the cervical cancer problem worldwide. In addition, there is evidence that HPV vaccines prevent new HPV infections, but don’t protect women who are already infected with HPV. Hence, entire generations of women will still depend on more traditional approaches to cervical cancer prevention than anti-HPV vaccination. Thus, a complete understanding of the molecular mechanisms of development of this disease remains vital to effective prevention and treatment measures for cervical cancer and other HPV-mediated diseases.

Together with the concept that HPV is necessary for cervical cancer development came the realization that HPV infection is not as long-lived as previously thought. In fact, the majority of women with cervical HPV will clear the infection within 9 to 24 months, and revert to HPV negative status, under a clinical point of view. Whether that means that the HPV is gone completely, or gone latent, is a matter of debate and probably both possibilities are viable. Only relatively few women have what is referred to as persistent HPV infection. And, as one perhaps would have expected, HPV persistence is associated with a greater risk of progression to cervical cancer, while women in whom the infection resolves spontaneously are not at all likely to develop disease. Thus, a careful use of HPV testing may aid in narrowing down the number of women who undergo colposcopy as a follow-up for an abnormal Pap smear. Large, multi-center clinical trials conducted a few years ago provided ample support to this concept.

Another advancement that improved dramatically cervical cancer screening has been the introduction to practice of liquid cytology methods, which allow for the collection and performance of the Pap smear in an automated fashion, and with methods that virtually guarantee a good quality specimen. A corollary of that technique is that abundant sample remains after all diagnostic procedures are completed to allow for a variety of studies to be performed, including HPV testing, and studies of various biomarkers that may be linked to progression.

• All women should begin cervical cancer screening about 3 years after they begin having vaginal intercourse, but no later than when they are 21 years old. Screening should be done every year with the regular Pap test or every 2 years using the newer liquid-based Pap test.
• Beginning at age 30, women who have had 3 normal Pap test results in a row may get screened every 2 to 3 years with either the conventional (regular) or liquid-based Pap test. Women who have certain risk factors such as diethylstilbestrol (DES) exposure before birth, HIV infection, or a weakened immune system due to organ transplant, chemotherapy, or chronic steroid use should continue to be screened annually.
• Another reasonable option for women over 30 is to get screened every 3 years (but not more frequently) with either the conventional or liquid-based Pap test, plus the HPV DNA test.
• Women 70 years of age or older who have had 3 or more normal Pap tests in a row and no abnormal Pap test results in the last 10 years may choose to stop having cervical cancer screening. Women with a history of cervical cancer, DES exposure before birth, HIV infection or a weakened immune system should continue to have screening as long as they are in good health.
• Women who have had a total hysterectomy (removal of the uterus and cervix) may also choose to stop having cervical cancer screening, unless the surgery was done as a treatment for cervical cancer or precancer. Women who have had a hysterectomy without removal of the cervix should continue to follow the guidelines above.

Cervical cancer screening rates (i.e., Pap test within past three years) are high, yet adherence to recommended follow-up care for abnormal Pap tests is less than ideal. Only about one-third (15-42%) of women follow-up as recommended, while ideally all women who are directed to follow-up should receive follow-up care. Knowledge and understanding of HPV infection, the main etiologic factor in cervical cancer, is very low among the general public. In particular, current methods of communicating cervical cancer risk factors and recommended screening services may contribute to misunderstanding and subsequently lower adherence to recommended follow-up care among African American women, especially those with lower levels of health literacy. Appropriate HPV and cervical cancer communication strategies could result in sustained cervical cancer screening rates, improved understanding of cervical cancer risk factors, including HPV, and greater adherence to diagnostic and follow-up care procedures of abnormal Pap test results. This is a woman's best defense against developing cervical cancer. The optimal content, format, and strategies for cervical cancer communications to achieve understanding and adherence among women of lower health literacy should receive more research attention. How socio/culturally-based beliefs about cervical cancer, literacy-based levels of understanding, and barriers to care interact to affect cancer prevention efforts is largely unknown. Yet this knowledge is critical to developing successful patient, clinician, and general public health communication messages and campaigns.

1. Physicians are unwilling to test for an infection for which there is no cure, particularly if the infection is sexually-transmitted.
2. Information about transmission rates, degree of protection afforded by condoms, and other possible methods of preventing the infection is controversial at best.
3. News of a viral infection that may lead to cancer can be extremely stressful to patients, and again there is nothing the doctors can do to cure the infection.
4. Facts about HPV infection and cancer may be quite difficult to explain in simple, non-technical words.

The same concepts should be at the basis of public education campaigns aimed at educating people about cervical cancer screening, and encouraging responsible sexual behavior and informed choices. In this context, and based on the above considerations, one wonders whether it might not be futile to attempt making recommendations for the prevention of HPV infection. Once the HPV vaccine is fully developed and available, we can expect to see HPV infection rates decrease dramatically, and cervical cancer incidence and mortality rates should follow suit. Until then, however, the focus must remain on cervical cancer prevention. The best tools at our disposal today are the Pap smear performed by liquid cytology methods, coupled with a careful use of HPV testing.

Volume 5, December 2004-January 2005. As of 2004, approximately half of 37.2 million HIV-positive adults are women. The sharp increases in HIV-positive numbers have been in East Asia, Eastern Europe and Central Asia, with rates in women much higher than those for men. The number of people living with HIV globally has also reached its highest. There is an estimated 39.4 million people living with HIV globally, up from an estimated 36.6 million in 2002, fuelled mainly by unprotected sex and intravenous drug use.

Over the past two years the number of women living with HIV has risen in every region of the world. Women at present make up nearly half of the 37.2 million adults aged 15-49 living with HIV worldwide. In sub-Saharan Africa about 60% of those with HIV are women. In the young population aged 15-24, this rises to 75%.Over the past two years alone, the number of women infected in East Asia has increased by 56%. In Eastern Europe and Central Asia the number has increased by 48%.

UNAIDS said there were a number of reasons for the gender trend. Women are more physically susceptible to HIV infection than men, and male-to-female transmission during sex is about twice as likely to occur as female-to-male transmission. Millions of women and girls are becoming sexually active each day with no access to preventive services or education. It seems that women are bearing the brunt of the epidemic globally. Many in monogamous relationships do not believe they have the right to ask their husbands to use a condom, even if he had proven himself to be unfaithful and was HIV-positive. In Asia , the Caribbean and sub-Saharan Africa, using sex as a commodity in exchange for goods, services or other basic necessities is becoming common among women. Others are violently forced to have unprotected sex.

UNAIDS hopes to reverse the trend through its Global Coalition on Women and Aids. Dr Peter Piot, UNAIDS executive director, said: "Strategies to address gender inequalities are urgently needed if we want a realistic chance at turning back the epidemic.

More extensive research into prevention methods such as microbicides, adequate education and treatment options, is vital in order to help inhibit the spread of HIV.

The Department for International Development is focused to reverse the spread of AIDS, especially amongst young women. The Department is proposing to spend £1.5 billion on HIV prevention, treatment and care and medical research over the next three years.