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Devices That Keep the Heart Beating   Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com July 1st, 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

Controlling Cholesterol with Statins

Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com June 1st, 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 7th   -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   Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

FDA Public Health Update   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 1st, 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.   Share your Favorite articles on the following Social Networks: Share on Facebook

Animal Cloning and Food Safety-FDA’s Perspective   Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com Feb 1st, 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 Share your Favorite articles on the following Social Networks: Share on Facebook

2007: A Review Of Notable Public Health Issues By WHO   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. Share your Favorite articles on the following Social Networks: Share on Facebook

Liposuction – FDA Advisory   Credit: FDA Consumer Health Information e-published on  MedicineandBiotech.com  December 1st, 2007     Liposuction involves inserting a needle through the skin and drawing out some of the underlying fat. Liposuction is the most popular form of cosmetic surgery in the United States, according to the American Society for Aesthetic Plastic Surgery (ASAPS). The 403,684 liposuction procedures performed on Americans in 2006 represent a 128% increase over the number performed in 1997. Interestingly, this same procedure—during the same year—was the top cosmetic surgery performed on men in the United States. In addition, the 383,885 liposuction procedures performed on U.S. women ranked second only to breast augmentation.   This article covers the following topics:   * Regulation * Who Can Perform Liposuction Surgery? * What are the Risks? * More Factors to Consider   If you are considering joining the millions of people worldwide who have had liposuction, FDA's Center for Devices and Radiological Health, which regulates the medical products used in liposuction, suggests you consider the following before having the surgery:   * Liposuction is intended only for body contouring. It is not intended as a means of weight loss.   * During liposuction, body fat is removed from under the skin with the use of vacuum suction—either with a hollow pen-like instrument called a "canula," or an ultrasonic probe that breaks fat up into small pieces and then removes it.   * While physicians may perform liposuction on the abdomen, hips, thighs, calves, arms, buttocks, back, neck, or face, it has never been cleared for use on the neck or face.   * Liposuction is also used in medical procedures such as reduction of mens' breast size and removing fat tumors (lipomas).   Regulation In the United States, FDA regulates the sale of medical devices and drugs that physicians use to perform liposuction. This includes equipment such as canulas, pumps, collecting containers, and ultrasound probes, as well as anesthetics used during the procedure.   FDA does not have authority to:   * regulate a doctor's practice. * tell a doctor how to run his or her business. * tell a doctor what he or she can or cannot tell patients. * set the amount a doctor can charge for liposuction surgery. *  insist that patient information be provided to potential patients.   FDA also cannot recommend individual doctors, clinics, or liposuction centers. (The agency does not maintain or have access to lists of doctors performing liposuction.) conduct or provide a rating system on medical devices it regulates.     Who Can Perform Liposuction Surgery? Plastic surgeons and dermatologists often perform liposuction, but any licensed physician may perform the procedure.   While some physicians' professional societies recommend it, no standardized training is required for conducting liposuction. You may want to base your decision to have liposuction on whether or not a doctor has had specialized training in the procedure, and has successfully performed it before.   Liposuction may be performed in a doctor's office, surgical center or hospital. Because it is a surgical procedure, it is important that   * it be performed in a clean environment * there be access to emergency medical equipment or a nearby hospital emergency room.   Remember, even the best-screened patients under the care of the best-trained and experienced physicians may experience complications as a result of liposuction.     What are the Risks? Infections can become serious issues. Keep the wounds clean.   Embolisms may occur when loosened fat enters the blood through blood vessels ruptured during liposuction. Pieces of fat can wind up in the lungs, or even the brain. Fat emboli may cause permanent disability or, in some cases, be fatal.   Puncture wounds in the organs (visceral perforations) may require surgery for repair. They can also prove fatal.   Seroma is a pooling of serum, the straw-colored liquid from your blood, in areas where tissue has been removed.   Paresthesias (changes in sensation that my be caused by nerve compression) is an altered sensation at the site of the liposuction. This may either be in the form of an increased sensitivity (pain), or numbness in the area. In some cases, these changes in sensation may be permanent.   Swelling, in some cases, may persist for weeks or months after liposuction.   Skin necrosis occurs when the skin above the liposuction site changes color and falls off. Large areas of skin necrosis may become infected with bacteria or microorganisms. Burns can occur during ultrasound-assisted liposuction if the ultrasound probe becomes hot.   Fluid imbalance may impact you after you go home. The condition can result in serious ailments such as heart problems, excess fluid collecting in the lungs, or kidney problems.   Toxicity from anesthesia due to the use of lidocaine, a skin-numbing drug, can cause lightheadedness, restlessness, drowsiness, a ringing in the ears, slurred speech, a metallic taste in the mouth, numbness of the lips and tongue, shivering, muscle twitching and convulsions. Lidocaine toxicity may cause the heart to stop.   Scars at the site of the incision are usually small and fade with time, although some may be larger or more prominent.   Bumpy or wavy appearances can occur at the liposuction site after the procedure.     Report Problems to FDA Health professionals or consumers should report serious adverse reactions or other problems related to equipment or medications used for liposuction through FDA’s MedWatch Program (www.fda.gov/medwatch/).   The Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illness and injuries associated with the use of medical devices. Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Branch, by phone on 240-276-3000, or write to, Reporting Systems Monitoring Branch, 1350 Piccard Drive HFZ-533, Rockville, MD 20850   For more information, visit www.fda.gov/cdrh/liposuction/   More Factors to Consider Will you like your looks after liposuction? The cosmetic effect after liposuction may be very good and many patients report being satisfied. However, your appearance afterward may not be what you expected or wanted. Some physicians counsel their patients that reasonable expectations are important.   The results may not be permanent. If you gain weight after liposuction surgery, the fat may return to sites where you had liposuction or to other sites.   Liposuction is not for everyone. You are probably not a good candidate for liposuction surgery if cost is an issue. Most medical insurance will not pay for cosmetic liposuction, and the cost may be significant. You are also probably not a good candidate if you are overweight or obese and trying to lose weight, if you have a disease or are on medication that affects wound healing, or if your skin elasticity is inadequate. Lack of skin elasticity can cause the area the fat was removed from to be baggy after liposuction.   There are alternatives. These include changing your diet to lose excess body fat, exercising, accepting your body and appearance as it is, or using clothing or makeup to downplay or emphasize body or facial features.   Make sure you understand the procedure and what you can expect. It is important for you to read the patient information that your doctor provides so that you understand the risks involved. Ask about potential problems that could occur, and ask about the physician's experience in performing liposuction.   How accurate is the advertising? Be wary of advertisements that say or imply you will have a perfect appearance after liposuction. Remember that advertisements are meant to sell you a product or service. Also, don't base your decision simply on cost.   Don't be pressured. Take your time to decide whether liposuction is right for you and whether you are willing to take the risks of the surgery for its benefits.   ***

FDA Announces Initiative to Bolster Generic Drug Program

Credit: FDA Consumer Health Information e-published on MedicineandBiotech.com November 1st, 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/ Share your Favorite articles on the following Social Networks: Share on Facebook

The Benefits and Risks of Pain Relievers: Q & A on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)   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 1st, 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.