FDA Alert News May 2007

FDA Alert News May 2007 - Food and drug administration press release for may 2007

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FDA Alert News May 2007
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Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeitprescription drugs.

On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical.html.

Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online. Consumers are urged to review the FDA Web page at www.fda.gov/buyonline/ for additional information prior to making purchases of prescription drugs over the Internet.

The 24 Web sites appear on pharmacycall365.com.

AllPills.net
Pharmacy-4U.net
DirectMedsMall.com
Brandpills.com
Emediline.com
RX-ed.com
RXePharm.com
Pharmacea.org
PillsPharm.com
MensHealthDrugs.net
BigXplus.net
MediClub.md
InterTab.de
Pillenpharm.com
Bigger-X.com
PillsLand.com
EZMEDZ.com
UnitedMedicals.com
Best-Medz.com
USAPillsrx.net
USAMedz.com
BluePills-Rx.com
Genericpharmacy.us
I-Kusuri.jp

FDA Commissioner Announces New Food Protection Position

Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach today announced the creation of the position of Assistant Commissioner for Food Protection to provide advice and counsel to the Commissioner on strategic and substantivefood safety and food defense matters.

David Acheson, M.D., F.R.C.P. will be assigned to this new senior leadership role.

Currently, Dr. Acheson serves as chief medical officer and director of the Office of Food Defense, Communication and Emergency Response at the Food and Drug Administration's(FDA) Center for Food Safety and Applied Nutrition (CFSAN).

In his new role, Dr. Acheson will work with individual FDA product centers, as well as the Office of Regulatory Affairs to coordinate FDA's food safety and defense assignments and commitments.

In addition, Dr. Acheson will serve as the commissioner's direct liaison to the Department of Health and Human Services, of which FDA is a part, and to other U.S. departments and agencies on food safety and food defense related inter-agency initiatives.

"The protection of America's food supply and therefore the safety of Americans eating food of domestic or international origin is of utmost importance to me as a physician, and to the mission of this agency," Dr. von Eschenbach said. "We've seen a rapid transformation of the food safety system due to advances in production technology, rapid methods of distribution, and the globalization of food sources. Dr. Acheson's wealth of experience, and knowledge of the science behind food protection, will help the agency keep pace with this transformation in order to ensure that the safety and nutritional value of our food supply is second to none."

One of Dr. Acheson's first projects will be the development of an agency-wide, visionary strategy for food safety and defense. The strategy will identify and characterize changes in the global food safety and defense system, and identify current and future challenges and opportunities. It will also name potential barriers, gaps, and most critical needs in a food safety and defense system. The strategy will serve as the framework in helping the agency prioritize and address food safety and defense challenges.

As a CFSAN office director, Dr. Acheson currently has had the lead for emergency response, as well as outreach and communications to industry, state and consumers on issues pertaining to the center. He manages a staff of epidemiologists, biostatisticians and others in providing risk assessments, aid in epidemiological investigations of foodborne outbreaks, and other important center-wide functions.

Before joining the agency, Dr. Acheson held several research and academic positions. He has served as an associate professor at the University of Maryland Medical School in Baltimore, where he focused on research of foodborne pathogens and, prior to that, as an associate professor at Tufts University in Boston, where he undertook basic molecular pathogenesis research on foodborne pathogens.

Dr. Acheson is a graduate of the University of London Medical School in the United Kingdom, with training in internal medicine and infectious diseases. He has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. Additionally, Dr. Acheson is a fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America.

Dr. Acheson will begin this new assignment immediately. He will report to Dr. Murray Lumpkin, Deputy Commissioner for International and Special Programs.

Joint Update: FDA/USDA Trace Adulterated Animal Feed to Poultry

WASHINGTON, April 30, 2007 – The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) have learned that byproducts from pet food manufactured with contaminated wheat gluten imported from China have been used in chicken feed on some farms in the state of Indiana. This information came to light as part of the continuing investigation into imported rice protein concentrate and wheat gluten that have been found to contain melamine and melamine-related compounds.

At this time, the investigation indicates that approximately 30 broiler poultry farms and eight breeder poultry farms in Indiana received contaminated feed in early February and fed it to poultry within days of receiving it. All of the broilers believed to have been fed contaminated product have since been processed. The breeders that were fed the contaminated product are under voluntary hold by the flock owners.

As with exposure from hogs fed contaminated pet food and for similar reasons related to the dilution of the contamination, FDA and USDA believe the likelihood of illness after eating chicken fed the contaminated product is very low. Because there is no evidence of harm to humans associated with consumption of chicken fed the contaminated product, no recall of poultry products processed from these animals is being issued. Testing and the joint investigation continue. If any evidence surfaces to indicate there is harm to humans, the appropriate action will be taken.

Because the poultry being held have been fed adulterated products, USDA cannot knowingly approve products derived from these poultry for human consumption. USDA is offering to compensate producers who euthanize this poultry. USDA is also offering the expertise and assistance of Animal and Plant Health Inspection Service (APHIS) personnel in carrying out depopulation activities, to ensure adherence to Federal and State laws.

FDA and USDA anticipate that as the investigation continues additional farms will likely be identified that received contaminated feed. As indicated in previous updates, FDA and USDA have also traced contaminated feed to swine farms in several states. The same procedures are being followed in relation to both swine and poultry; animals are being quarantined by state order or voluntarily held by the owners and USDA is offering compensation for depopulation and disposal of both swine and poultry that have been fed contaminated products.

USDA and FDA continue to conduct a full, comprehensive examination to protect the nation’s food supply and will provide updates as new information is confirmed.

Joint Update: FDA/USDA Update on Tainted Animal Feed

The U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) continue their investigation of imported rice protein concentrate which has been found to contain melamine and melamine-related compounds. Based on information currently available, FDA and USDA believe the likelihood of illness after eating pork from swine fed the contaminated product would be very low. The agencies are taking certain actions out of an abundance of caution. As announced on April 26, swine known to have been fed adulterated (contaminated) product will not be approved to enter the food supply. (Because the animal feed in question was adulterated, USDA cannot rule out the possibility that food produced from animals fed this product could also be adulterated. USDA cannot approve potentially adulterated meat.) This update provides additional information regarding the ongoing investigation.

As reported on April 22 by FDA, the Agency determined that rice protein concentrate imported from China was contaminated with melamine and melamine-related compounds. The product was imported by Wilbur-Ellis, an importer and distributor of agricultural products. Although the company began importing product from China in August 2006, the company did not become aware of the contamination until April 2007. As part of the ongoing investigation, FDA has determined the rice protein was used in the production of pet food and a portion of the pet food was used to produce animal feed. The ongoing investigation is tracing products distributed since August 2006 by Wilbur-Ellis throughout the distribution chain.

At this time, we have no evidence of harm to humans associated with the processed pork product, and therefore no recall of meat products processed from these animals is being issued. Testing and the joint investigation continue. If any evidence surfaces to indicate there is harm to humans, the appropriate action will be taken.

The assessment that, if there were to be harm to human health, it would be very low, is based on a number of factors, including the dilution of the contaminating melamine and melamine-related compounds from the original rice protein concentrate as it moves through the food system. First it is a partial ingredient in the pet food; second, it is only part of the total feed given to the hogs; third, it is not known to accumulate in the hogs and the hogs excrete melamine in their urine; fourth, even if present in pork, pork is only a small part of the average American diet. Neither FDA nor USDA has uncovered any evidence of harm to the swine from the contaminated feed. In addition to the dilutional factor and the lack of evidence of illnesses in the swine fed the waste pet food, we are not aware of any human illness that has occurred from exposure to melamine or its by-products. While the Centers for Disease Control and Prevention systems would have limited ability to detect subtle problems due to melamine and melamine-related compounds, no problems have been detected to date. To further evaluate any potential harm to humans, the FDA is developing and implementing further tests and risk assessments based on the toxicity of the compounds and how much of the compounds consumers could be expected to actually consume.

The ongoing investigation and product reconciliation and testing have led to certain farms. We expect the investigation will continue to find more places where product may have been distributed. As of April 26, sites in the following states are believed to have received and used contaminated product: California, Kansas, New York, North Carolina, South Carolina and Utah. As we confirm additional sites that have received and used contaminated product, we will provide additional updates.

USDA and FDA continue to conduct a full, comprehensive examination to protect the nation’s food supply and will provide updates as new information is confirmed.

FDA Approves Product to Treat Common Bleeding Disorder

The U.S. Food and Drug Administration (FDA) today approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (vWD). The disease is the most common inherited bleeding disorder, affecting about1 percent of the U.S. population.

Humate-P is the second biological product to be approved for the management of surgery and invasive procedures in patients with vWD in whom the medication desmopressin may not work. The first biological product, Alphanate, was approved by FDA in February. However, Humate-P is the first product specifically for patients with severe vWD who are undergoing major surgery.

"This is an important advance for patients with vWD, including those who are severely affected by the disorder," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. “Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."

The product was originally approved for use in adult patients to treat and prevent bleeding from hemophilia A. It was later approved to treat spontaneous and traumatic bleeding for severe vWD and for mild and moderate vWD when desmopressin use is known or suspected to be inadequate.

Humate-P is made by purification of the needed clotting protein from human plasma from carefully screened and tested U.S. donors. It undergoes steps to further reduce the risk for transfusion-transmitted diseases. While the risk for the transmission of bloodborne diseases is very low, it can not be eliminated.

FDA based its approval on a clinical study of Humate-P in 35 patients suffering from vWD who underwent a total of 28 major and seven minor surgical procedures. The product was judged excellent or good in 91 percent of the patients who avoided severe hemorrhage. The most common adverse reaction following surgery was hemorrhage, in 30 percent of the patients; however, only 9 percent of the hemorrhages were classified as severe. Other adverse reactions in patients following surgery included nausea (24 percent) and pain (17 percent).

Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most cases, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the United States each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated and possibly cause delayed wound healing.

Humate-P is manufactured by CSL Behring GmbH, Marburg, Germany.

Joint News Release: FDA and USDA Determine Swine Fed Adulterated Product

The USDA Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) today notified State authorities that swine fed adulterated product will not be approved to enter the food supply. Based on information currently available, FDA and USDA believe the likelihood of illness after eating pork from swine fed the adulterated product would be very low; however, the agencies believe it is prudent to takethis measure.

FDA determined that a shipment of rice protein imported from China was contaminated with melamine and melamine-related compounds. The product was imported during the week of April 2, 2007 by Wilbur-Ellis, an importer and distributor of agricultural products. The rice protein was used in the production of pet food and a byproduct was used to produce animal feed.

The contaminants in question include melamine and melamine-related compounds, including cyanuric acid, the combination of which is a potential source of concern in relation to human and animal health. Scientific research indicates that melamine alone, at detected levels, is not a human health concern. However, no scientific data exist to ascertain the effects of combining melamine and melamine-related compounds. Therefore, a determination has not yet been made regarding the safety of the product.

Because the animal feed in question was adulterated, USDA cannot rule out the possibility that food produced from animals fed this product could also be adulterated. Therefore, USDA cannot place the mark of inspection on food produced from these animals.

USDA is offering to compensate producers who euthanize swine that were fed the adulterated product. USDA is authorized to use Section 32 funds to restore farmers’ purchasing power. USDA is also offering the expertise and assistance of Animal and Plant Health Inspection Service (APHIS) personnel in carrying out depopulation activities, to ensure animals are euthanized and disposed of in accordance with Federal and State laws.

FDA and FSIS are coordinating with State authorities in eight states where the adulterated feed is known to have been purchased. Eight pork producers in the states of California, Kansas, North Carolina, New York, Oklahoma, South Carolina and Utah are known to have purchased the feed. These combined operations involve approximately 6,000 hogs. All of the animals are currently being held under state quarantines in CA, NC, NY and SC. In KS, OK and UT producers agreed to hold the animals until further notice. Authorities are also in contact with a feed mill in Missouri that might have received adulterated feed.

Pork and pork products derived from animals that were fed the adulterated product will also be destroyed. In CA and UT, pork from federally inspected plants is being held under FSIS direction. In SC, a state inspected plant is voluntarily holding swine that were fed the adulterated product. FSIS, FDA and state authorities are in the process of determining whether any meat from animals that were fed the adulterated product has entered commerce. If that has occurred, FSIS will work with states and industry to take the appropriate action.

FDA and FSIS are continuing the effort to trace the adulterated feed. If additional producers are identified who fed the adulterated product to animals, they will also be offered compensation by USDA for depopulation and disposal.

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices

The U.S. Food and Drug Administration (FDA) announced the entry of a Consent Decree of Permanent Injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products. The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

“Drug approval and CGMP compliance are part of the foundation of drug safety,” said Steven K. Galson, M.D., M.P.H, director of FDA’s Center for Drug Evaluation and Research (CDER). “When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively.”

PharmaFab is a major contract manufacturer and distributor of more than 100 different prescription and over-the-counter drug products, including cough and cold products, ulcer treatments, and postpartum hemorrhage products. Consumers who have products manufactured by PharmaFab should consult with their physician.

The unapproved drugs manufactured by PharmaFab include, but are not limited to:

Because these drugs have not undergone FDA approval, their safety and effectiveness have not
been established, and FDA has not reviewed the adequacy and accuracy of the directions and
warnings in their labeling.

According to the complaint filed with the court, PharmaFab did not comply with CGMP by not investigating manufacturing failures and not recording and justifying why it deviated from written manufacturing procedures. Further, the company lacked an effective quality control unit and failed to establish reliable expiration dates for products. Compliance with CGMP is necessary to ensure that drugs have the requisite safety, identity, strength, quality, and purity.

The consent decree requires the defendants to destroy certain illegal drugs, and bars them from distributing all drugs until they obtain required FDA approval and fully comply with CGMP. If they resume distributing drugs, the defendants are required to retain an auditor to conduct inspections of their facilities for a period of five years and to provide reports to FDA analyzing compliance with CGMP and labeling requirements. The decree also allows FDA to require recall or shutdown in the event of future violations and provides for damages of $5,000 per day and $1,000 per violation, up to a maximum of $5 million per year, if the defendants fail to comply with its terms.

“FDA will not hesitate to pursue enforcement action when necessary,” said Margaret O’K. Glavin, FDA's associate commissioner for regulatory affairs. “We will continue to protect public health by carefully monitoring the provisions of this injunction. FDA will also continue to investigate and take action against other marketers of unapproved drugs.”

In June 2006, FDA issued a guidance document entitled, “Marketed Unapproved Drugs—Compliance Policy Guide” (CPG). The CPG makes clear that firms may not market drugs that require approval without first establishing in applications that the products are safe and effective. One of the priorities in this CPG is enforcement actions against manufacturers that violate other provisions of the Federal Food, Drug, and Cosmetic Act.

For more information:

FDA’s ongoing efforts on marketing unapproved drugs
www.fda.gov/cder/drug/unapproved_drugs

CDER’s Web page on Compliance with Current Good Manufacturing Practices www.fda.gov/cder/dmpq/.

FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia

The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated for the short-termtreatment of insomnia.

"The FDA’s Office of Generic Drugs ensures that generic drugs are safe and effective for the American public through a rigorous scientific and regulatory process," said Gary J. Buehler, director, Office of Generic Drugs. "Thisapproval offers Americans more alternatives when choosing their prescriptiondrugs."

Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.

In March, FDA requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. For more information see www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html. Generic versions of these drugs will also include this labeling.

According to the online magazine Drug Topics, in 2006, Ambien was the 13th highest selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, 2007.

The FDA’s Office of Generic Drugs (OGD) reviews and decides on approval of generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/.

For more information about generic drugs, please see the FDA Consumer article, Generic Drugs: What You Need to Know at www.fda.gov/fdac/features/2002/502_generic.html. For additional information related to FDA's Office of Generic Drugs, please see: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

FDA Announces Audio Broadcasts on Emerging Drug Safety Information

The U.S. Food and Drug Administration (FDA) is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information. The broadcasts, commonly known as podcasts,can be transmitted to personal computers and personal audio players.

The service is part of the agency's ongoing effort to broaden and speed its communications  concerning the safety of marketed medications when unexpected adverse events are reported to FDA. The broadcasts are an addition to FDA's traditional print- and Web-based public health advisories (PHAs) and anyone can subscribe to them for free at http://www.fda.gov/cder/drug/podcast/default.htm.

"FDA's highest priority is to protect and enhance the health of the American public," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "The service contributes to this goal by providing a new venue for busy health care professionals and patients to find drug safety information, so that they don't have to look for it on FDA's Web site or read about it in print. Timely and widely available broadcasts about previously unknown potential drug risks should help ensure that these productsare used safely and effectively."

Since the service was launched in February 2007, it has alerted listeners to the potential hazards of skin-numbing products used in hair removal; the voluntary market withdrawals of drugs to treat the symptoms of Parkinson's disease and irritable bowel syndrome, and to serious adverse events associated with agents that reduce the need for blood transfusions in cancer patients.

The American Medical Association (AMA) welcomed the FDA audio broadcast. "This innovative development can help physicians provide the best treatments to their patients and improve patient safety," said Edward Langston, M.D., an AMA Board member.

In the broadcasts, FDA asks healthcare providers and patients to report adverse side effects from medical products to MedWatch. MedWatch reports can be made by phone: at 1-800-FDA-1088; fax: 1-800-FDA-0178; or via the Internet at http://www.fda.gov/medwatch/index.html.

Worldwide Fish and Seafood, Inc. Enters Consent Decree with FDA

The U.S. Food and Drug Administration (FDA) today announced that Worldwide Fish & Seafood, Inc., Minneapolis, MN, (doing business as Coastal Seafood) a seafood processor and three of its officers have entered into a consent decree of permanent injunction due to violations of the Federal Food, Drug and CosmeticAct.

The consent decree requires the company to come into compliance with the act by developing and implementing adequate Hazard Analysis and Critical Control Point (HACCP) plans.

The seafood HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards.

Over six years, seven FDA inspections revealed that the defendants' HACCP plans were not adequate to prevent conditions that could pose a potential public health risk. In particular, the defendants' HACCP violations related to their failure to ensure that their seafood products were transported and continuously stored at adequate refrigeration temperatures to prevent bacteria growth and pathogen development.

The defendants agreed to come into compliance with the act and its implementing regulations by, among other requirements: obtaining an expert consultant to evaluate the HACCP plans for all of the defendants' products and the defendants' implementation of the plans; and submitting to FDA inspection to ensure that the HACCP plans are being adequately implemented.

The defendants have already received FDA approval of the HACCP plans prepared by their expert and currently in use.

The decree allows FDA to order a shutdown, recall, or other corrective action in the event of future violations, and requires the defendants to pay the costs of inspections performed pursuant to the decree.

The decree was entered by Judge Joan Erickson of the U.S. District Court for the District of Minnesota on April 18, 2007.

FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations

U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products,particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. FDA will issue a Preliminary Public Health Notification to physicians and other health care professionals and a Preliminary Advice for Patients shortly with more information; those documents will be posted to FDA's Web site.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters.

Medical devices manufactured by Shelhigh include:

FDA Approves Antibiotic Ointment for Children and Adults

The Food and Drug Administration (FDA) approved Altabax (retapamulin ointment) for topical treatment of impetigo (http://www.nlm.nih.gov/medlineplus/impetigo.html), a skin infection caused by bacteria. Altabax is indicated for use in patients aged nine months or older. Retapamulin is a new molecular entity (NME) not previously approved in the United States.

Altabax was approved on the basis of effectiveness data from a placebo-controlled study supported by a study comparing Altabax to another antibiotic. The safety database contained approximately 2,000 Altabax-treated adults and children aged nine months and older, and about 1,000 similar patients who received different antibiotics or placebo. The most common Altabax-related adverse event was irritation at the site of the application, which occurred in less than two percent of the patients.

To reduce the development of drug-resistant bacteria, and maintain the effectiveness of Altabax and other antibacterial drugs, this product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. This product will be available by prescription.
 
Altabax is manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of genericversions of commonly used drugs.

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.

"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."

Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.

While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.

For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.

To learn more about the Critical Path Initiative consult:
www.fda.gov/oc/initiatives/criticalpath/

Information on FDA's Generic Drug Office is available at:
www.fda.gov/cder/ogd/index.htm.

FDA Requests Recall of All Shelhigh Medical Devices

The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining inthe marketplace, including hospital inventories, because of sterility concerns.

On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.

FDA recommends that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html and www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html for more information, including a list of the company's products.

"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

The company's deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices. Shelhigh's own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.

Adverse reactions or quality problems experienced with the use of these products may be reported to FDA's MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), fax (800-332-0178), or regular mail (use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787).

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initialtreatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)

For more information:

Antidepressant use in children, adolescents, and adults, including the draft labeling and draft Medication Guides www.fda.gov/cder/drug/antidepressants/default.htm

FDA's Psychopharmacologic Drugs Advisory Committee, including transcripts from the December 2006 meeting www.fda.gov/ohrms/dockets/ac/cder06.html#Psychopharmacologic

Food and Drug Administration Press Releases

Keeping up with the latest consumer health information from the U.S. Food and Drug Administration (FDA) just got easier. FDA today announced two new initiatives to enhance online communications. A Web page, "Consumer Health Information for You and Your Family" (www.fda.gov/consumer),provides comprehensive and timely consumer information. A free monthly e-newsletter, "FDAConsumer Health Information" (www.fda.gov/consumer/consumerenews.html),will alert consumers to content contained on the page.

"The Web page and e-newsletter are important new consumer resources that will feature timely stories on pressing FDA topics, provide links to our most requested information, and include interactive content," says Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs.

The new consumer Web page will present important public health developments clearly and accurately in easy-to-read language. A current article describes FDA's ongoing investigation of the recent recall of more than 100 brands of pet food due to potential contamination. Other current articles discuss the benefits and risks of pain relievers, facts about generic drugs, and what FDA is doing to keep produce safe.

The page also provides links to useful information about the various products that FDA regulates, including food, human and animal drugs, medical devices, and vaccines and other biologics. The page also links to health information available from other U.S. government sources, and provides essential health information in Spanish.

The e-newsletter replaces the agency's print magazine and is expected to reach far more people. Subscribers will receive notice of product approvals, safety warnings, and other health news.

FDA invites feedback on the new Web page and the e-newsletter. Comments and questions may be sent via email to fdaconsumerlist@oc.fda.gov or mailed to FDA Consumer Health Information, Food and Drug Administration, HFI-40, Room 15-A29, Fishers Lane, Rockville, MD 20857.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG). DEG is a known poison used in antifreeze and as a solvent. Today, the agency is issuing guidance to industry recommending methods of testing glycerin and other controls to identify any contamination with DEG before use in the manufacture or preparation of pharmaceutical products.

At the present time, FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.

DEG poisoning is an important public safety issue and FDA is exploring how supplies of glycerin become contaminated. In addition, FDA is working with a variety of manufacturing and pharmacist organizations to raise awareness of this risk and to put into place controls to ensure that this problem does not happen in the U.S. or elsewhere.

The most recent incident occurred in Panama in September 2006 and involved DEG-contaminated glycerin used in cough syrup, which resulted in dozens of hospitalizations for serious injury and more than 40 deaths. In late 1995 and early 1996, at least 80 children died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup. Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths. In 1937, more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections. This incident led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation's primary statute on the regulation of drugs.

FDA reminds pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP). The guidance provides recommendations for complying with CGMP and is intended to help manufacturers, compounders, repackers, and suppliers avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.

For a copy of the guidance, go to http://www.fda.gov/cder/guidance/7654fnl.htm

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today cleared for marketing the first respirators that can help reduce the user's exposure to airbornegerms during a public health medical emergency, such as an influenza pandemic.

These two filtering facepiece respirators, manufactured by St. Paul, Minn.-based 3M Company (and called the 3M Respirator 8612F and 8670F), will be available to the general public without a prescription.

The devices are also certified as N95 filtering facepiece respirators by the National Institute for Occupational Safety and Health (NIOSH). NIOSH certifies respirators for use in occupational settings in accordance with an appropriate respiratory protection program.

An N95 filtering facepiece respirator is a type of face mask that fits tightly over the nose and mouth. It is made of fibrous material that is designed to filter out at least 95 percent of very small airborne particles. The filter and a proper fit determine the effectiveness of the product.

"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events."

Many companies make N95 respirators for workplaces, including health care settings. However, the 3M respirators are the first devices to receive FDA clearance for use by the public during public health medical emergencies to reduce exposure to airborne germs.

Under Occupational Safety and Health Administration and other occupational health regulations, respirators used in the workplace must be individually selected for each worker and tested to ensure a proper fit. This kind of fit testing is not generally employed outside the workplace now and would probably not be feasible during a public health medical emergency.

FDA is requiring those who want to market respirators for use during public health medical emergencies to assure that they are certified by NIOSH to provide adequate filtration without hampering people's ability to breathe. In addition, companies must conduct fit assessment testing, conduct biocompatibility testing to reduce the chance for allergic skin reaction, and provide instructions that will enable wearers to achieve a protective fit and use the devices properly.

3M evaluated fit characteristics in healthy adults to determine that a user could achieve a protective fit following the instructions on the label. They measured how many airborne test particles were able to get inside the respirator through small leaks between the edges of the respirator and the wearer's face. While individual results varied, all participants tested achieved some reduction in exposure to airborne test particles.

The 3M respirators are sized for adults and may not form a proper fit on children. Anything that comes between the respirator and the face, such as facial hair, may interfere with its fit. Persons with pre-existing heart or lung disease or other health conditions may have difficulty breathing through a respirator. The devices are for single use. Wearers should not wash, disinfect, reuse or share their respirator with others. The respirators should be discarded after use.

FDA will soon issue a guidance document outlining its regulatory approach to this new type of device.

Inhaling particles is just one route of exposure to disease-causing organisms. Others include touching contaminated surfaces and coming into close contact with those who have infectious diseases. A total approach to personal protection includes hand hygiene, cough etiquette and other protection practices such as avoiding crowded settings.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptomsof early Parkinson's disease.

Rotigotine is a drug not previously approved in the United States. Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson's disease.

Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptorsin the body, mimicking the effect of the neurotransmitter dopamine.

The effectiveness of Neupro was demonstrated in one fixed-dose response study and two flexible-dose studies. The parallel group studies were randomized, double-blinded, and placebo-controlled, and involved 1,154 patients with earlyParkinson's disease who were not taking other Parkinson's medications.

The most common side effects for Neupro included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness and insomnia, most of which are typical of this class of drugs. Other potential safety concerns include sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressureon standing up (postural hypotension).

Neupro Patch is manufactured by Schwarz Bioscience of Research Triangle Park,N.C.

According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. The four primary symptoms of Parkinson's are trembling in hands, arms, legs, jaw, and face (tremor); stiffness of the limbs and trunk (rigidity); slowness of movement (bradykinesia,); and impaired balance and coordination (postural instability). As these symptoms become more pronounced, patientsmay have difficulty walking, talking, or completing other simple tasks.

For more information
National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States. Both products -- touted as sexual enhancement products and as treatments for erectile dysfunction (ED) -- are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED.FDA encourages men who experience ED to seek guidance from a health care professional.

FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as "all natural" alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.

"These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products," said Steven Galson, M.D., MPH, director of the FDA's Center for Drug Evaluation and Research."The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure."

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.

True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.

True Man is sold in boxes containing a 10-capsule blister pack. Energy Max is sold in boxes containing two 10-capsule blister packs.Both products are distributed and packed by America True Man Health, Inc., West Covina, Calif.A review of the ingredient statements for both products revealed that neither piperadino vardenafil nor thione analog of sildenafil are listed as an ingredient, even though one or more of those ingredients is present in the products.

Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:
www.fda.gov/medwatch/report.htm
(800) 332-1080
Fax: (800) 332-0178
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787

For more information, visit: www.fda.gov/bbs/topics/NEWS/2006/NEW01409.html
www.fda.gov/foi/warning_letters/g5911d.htm

Food and Drug Administration Press Releases

Testing confirms that meat from swine fed rations supplemented with pet food scraps containing melamine and related compounds is safe for human consumption, prompting the U.S. Department of Agriculture (USDA) to allow swine held on farms to be released and approved for processing.

Testing of meat from swine exposed to the feed in question confirms that melamine and melamine compounds do not accumulate in pork and are filtered out of the body by the action of the kidneys.  The testing also bolsters the conclusions reached by a human health risk assessment that there is a very low risk of human illness from the consumption of meat from animals exposed to the feed in question. Swine known to have eaten this feed appear healthy, which will be confirmed as these animals undergo the rigorous inspection that FSIS provides for all meat and poultry prior to processing.

There were approximately 56,000 swine that consumed the feed in question and were held on farms in California, North Carolina, South Carolina, New York, Kansas, Utah and Illinois. USDA will provide compensation to producers for certain additional costs incurred as a result of voluntarily holding the animals. Approximately 100 million swine are processed each year in the U.S.

The process for testing meat from swine was validated by USDA’s Food Safety and Inspection Service (FSIS).

Human Health Risk Assessment

The human health risk assessment announced by the Food and Drug Administration (FDA) and USDA last week has been updated. It still concludes that there is very low risk of harm to humans from eating food containing low levels of melamine or related compounds.

The updated risk assessment concludes that in the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day contained melamine and the melamine compound cyanuric acid at levels potentially present in the meat, the potential exposure is about 250 times lower than the dose considered safe. Translated to consumption levels, this means that a person weighing 132 pounds would have to eat more than 800 pounds per day of pork or other food containing melamine and its compounds to approach a level of consumption that would cause a health concern. Previously, the agencies reported that the potential exposure was about 2,500 times lower than the safe level.

The initial human risk assessment assumed that tests of swine meat detected melamine and its compounds. The testing validation process, completed on May 12, revealed that while the swine meat test detects melamine, it cannot detect melamine related compounds. The updated assessment calculates risk based on the new updated  laboratory information that accounts for the presence of melamine and cyanuric acid, a melamine related compound detected in the contaminated feed.

In addition, the original risk assessment assumed that testing could detect levels of melamine and related compounds as low as 10 parts per billion (ppb) in pork. The new assessment assumes that testing can detect levels only as low as 50 ppb in pork, a more conservative assumption, and an even higher level of 100 ppb is assumed in order to account for the potential presence of cyanuric acid, in addition to melamine.

FDA and USDA are in the process of identifying scientific experts who would be charged with reviewing the updated risk assessment. They will be asked to provide their views to FDA as quickly as possible, with the intent of finalizing the risk assessment within several weeks.

Update on Other Affected Products

Approximately 80,000 poultry continue to be held at USDA’s request at farms in Indiana while a validated test for detecting melamine in poultry meat is developed. That test is expected later this week.

FDA is continuing its investigation into the presence of melamine and its compounds in fish feed manufactured by the Canadian company Skretting. The company is recalling all fish feed from all commercial fisheries and fish hatcheries that may have received it, including those in the United States. FDA has confirmed there are two U.S. commercial aquaculture establishments that received the feed. The fish in those two establishments are on hold and samples of the fish and the feed are being tested for melamine levels. Based on the human risk assessment, there is very low risk from eating fish that consumed feed containing melamine.

USDA and FDA continue to conduct a full and comprehensive investigation.  As additional information is confirmed, updates will be provided and decisions will be made using the best available science to protect the public’s health.

FDA Approves Expanded Use for Surgical Sealant

The U.S. Food and Drug Administration (FDA) today approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from smallblood vessels during surgical procedures.

"Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

This product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing, however, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.

In a pivotal study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within four minutes, compared with 39.7 percent in the control group.

Adverse events, such as anemia and graft site infection, were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.

FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Evicel is manufactured by OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated withAvandia.

Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.

FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

"FDA remains committed to assuring that doctors and patients have the latest information available to make treatment and medication use decisions. In this case, FDA is carefully weighing several complex sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We will complete our analyses and make the results available as soon as possible. FDA will take the issue of cardiovascular risk associated with Avandia and other drugs in this class to an Advisory Committee as soon as one can be convened."

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.

Avandia is manufactured by GlaxoSmithKline, which is based in Research Triangle Park, N.C.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging(MRI).

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF ifthey are experiencing kidney insufficiency of any severity.

"FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This latest action demonstrates FDA's continuing vigilance about ensuring the safety ofdrug products once they enter the marketplace."

Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006 . Information on the risks was updated in December.

Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.

NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.

Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.

There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.

Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are madeby Bracco Diagnostics Inc., Princeton, N.J.

For more information see www.fda.gov/cder/drug/infopage/gcca/default.htm.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) is warning consumers not to buy or eat imported fish labeled as monkfish, which actually may be puffer fish, containing a potentially deadly toxin called tetrodotoxin. Eating puffer fish thatcontain this potent toxin can result in serious illness or death.

Tetrodotoxin is not destroyed by common food preparation or storage, such as cooking or freezing. Monkfish do not contain tetrodotoxin.

The product was imported and distributed by Hong Chang Corp., Santa Fe Springs, Calif.

Consumers concerned that they may have purchased this fish should contact their retailer and ask if the product was received from Hong Chang Corp.

The product should not be eaten, it should be thrown away. Care should be exercised in handling the fish, as the tetrodotoxin may be present on the skin and flesh of the fish. Consumers should wash hands thoroughly after handling the fish.

Two people in the Chicago area became ill after consuming homemade soup containing the fish. One was hospitalized due to severe illness.

FDA's analysis of the fish confirmed the presence of potentially life-threatening levels of tetrodotoxin.

Initial symptoms of tetrodotoxin poisoning occur 30 minutes to several hours after food containing the toxin is consumed. Tetrotoxin poisoning is characterized initially by tingling of the lips and tongue. Tingling of the face and extremities and numbness follow. Subsequent symptoms may include headache, balance problems, excessive salivation, nausea, vomiting, diarrhea and abdominal pain. Consumers experiencing these symptoms should seek immediate medical care and are encouraged to report their illness to local health authorities. In severe cases, muscles can become paralyzed, and death may follow from respiratory muscle paralysis.

A total of 282 22-pound boxes labeled as monkfish were distributed to wholesalers in Illinois, California and Hawaii beginning in September 2006. These fish were then sold to restaurants or sold in stores. In one instance, the retailer labeled the fish as "bok," the Korean name for puffer fish.

The white 22-pound boxes were labeled in black ink. One box panel is labeled as: "FROZEN MONKFISH GUTTED AND HEAD-OFF" and "PRODUCT OF CHINA." A second panel bears nutritional facts and the following: "Ingredients: Monk fish; Imported by: Hong Chang Corp, Santa Fe Springs, CA 90670; Product of China (P.R.C.)." A third panel has a checkbox indicating the size as either "0.5-1" or "1-2" and shows the net weight as 22 pounds. There are no manufacturing codes on the box. The fish in the box are individually wrapped in plastic bags with no labeling.

FDA allows puffer fish to be imported into the United States only under strict provisions that minimize the risk of the toxin being present in the fish. The recalled fish were not imported in compliance with those restrictions. FDA is examining all entries from the Chinese supplier and will take additional action, if warranted.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today announced its intention to take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin, a substance commonly used in medicines to relieve cough and cold symptoms by stimulating removal of mucous from thelungs.

Approximately 20 firms make timed-release products containing guaifenesin that have not undergone FDA review and as a result are considered by the agency to be unapproved drugs.

"Today's action is another example of our commitment to ensure all drugs marketed in the United States that require FDA approval have that approval," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "This benefits consumers because drugs that skirt the approval process may be unsafe, may not work, and often have inadequate labeling or are improperly manufactured."

This action does not affect products containing guaifenesin in immediate release form, but rather only affects timed-release forms, often described as extended-release, long-acting or sustained-release. These dosage forms release their active ingredients over an extended period of time, reducing the number of doses needed per day. Many of the products that contain guaifenesin also contain other active ingredients that are intended to relieve nasal congestion, suppress cough, reduce fever or relieve pain.

Timed-release drugs require FDA approval because the FDA must ensure that the product releases its active ingredients safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work.

To date, only Adams Respiratory Therapeutics has obtained FDA approval for timed-release products containing guaifenesin (600 milligrams and 1200 milligrams) under the trade names of Mucinex and Humibid. These include over-the-counter products containing guaifenesin alone (Mucinex and Humibid), with the decongestant pseudoephedrine (Mucinex-D), and with the cough suppressant dextromethorphan (Mucinex-DM).

Companies marketing unapproved products containing guaifenesin in timed-release form are expected to stop manufacturing them within 90 days and must cease shipping them in interstate commerce within 180 days. A small amount of these products is expected to be available after these dates until supplies are exhausted.

After these dates, companies wishing to market products containing guaifenesin in timed-release form that do not have the required FDA approval must obtain approval or face regulatory action. FDA is committed to working with companies to facilitate the process of ensuring that products are safe and effective, and meet appropriate standards for manufacturing and labeling.

Today's action is part of FDA's broader initiative on marketed unapproved drugs that was launched in June 2006. At that time, the agency published a Compliance Policy Guide describing FDA's risk-based enforcement approach to unapproved drugs. The guidance explains that FDA intends to give priority to enforcement actions involving unapproved drugs with potential safety risks, that lack evidence of effectiveness and that constitute health fraud.

Additional Information about Guaifenesin.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced MedicalOptics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).

Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

All contact lens users should closely adhere to the following measures to help prevent eye infections:

FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration,5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma. Torisel was approved based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. The drug is an enzyme inhibitor, a protein that regulates cell production, cell growthand cell survival.

"We have made significant advances in the battle against kidney cancer,” said Steven Galson, M.D., M.P.H., director of the FDA’s Center for Drug Evaluation and Research. "Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients."

The approval of Torisel follows the December 2005 approval of Nexavar (sorafenib), which was based on a delay in progression of disease. In January 2006, Sutent (sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.

The safety and effectiveness of Torisel were shown in a clinical trial of 626 patients divided into three groups. One group received Torisel alone, another received a comparison drug called Interferon alfa, and a third received a combination of Torisel and interferon.

The group of patients who received Torisel alone showed a significant improvement in overall survival. The median overall survival was 10.9 months for patients on Torisel alone versus 7.3 months for those treated with the interferon alone. Progression-free survival (when the disease does not get worse) increased from 3.1 months on the interferon alone arm to 5.5 months on the Torisel alone arm. The combination of Torisel and interferon did not result in a significant increase in overall survival when compared with interferon alone.

The most common adverse reactions, occurring in at least 30 percent of Torisel-treated patients, were rash, fatigue, mouth sores, nausea, edema, and loss of appetite. The most common laboratory abnormalities were high blood sugar, elevated blood lipids and triglycerides, elevated liver and kidney blood tests, and low red cell, white cell, and platelet counts.

Renal cell carcinoma, diagnosed in about 51,000 people annually in the United States, accounts for about 85 percent of all U.S. adult kidney cancer.

Torisel is manufactured by Philadelphia-based Wyeth Pharmaceuticals, Inc.

Tembec and Uniscope Voluntary Recall Feed Ingredients

The U.S. Food and Drug Administration (FDA) is alerting livestock and fish/shrimp feed manufacturers about a voluntary recall of products used in feed production because several have been found to contain melamine and related compounds.

The feed ingredients were made by Tembec BTLSR Inc. of Toledo, Ohio and Uniscope, Inc. of Johnstown, Colo.

Tembec, a contract manufacturer for Uniscope, makes AquaBond and Aqua-Tec II, which it distributes for Uniscope. Uniscope makes Xtra-Bond using ingredients supplied by Tembec. All of the products are binding agents that are used to make pelleted feed for cattle, sheep, and goats, or fish and shrimp.

The companies have confirmed that Tembec added melamine as part of the formulation of the products to improve the binding properties of pelleted feed. Melamineis not approved as an additive for animal or fish/shrimp feed.

The companies have stopped adding melamine to the feed products.

Based on the levels of melamine and related compounds in the initial ingredients, FDA estimated the probable level of melamine and related compounds in livestock feed as less than 50 parts per million (ppm) based on the recommended mix rate of two to four pounds of binding agent per ton of livestock feed. The estimated levels in fish and shrimp feed are less than 233 ppm and 465 ppm, respectively, of melamine and related compounds. The estimated levels of melamine and related compounds vary in the livestock feed and the fish and shrimp feed because of differing levels of melamine in the binding agents used for each type of feed.

FDA advises feed manufacturers and others who mix their own feed not to use these products, and to contact the manufacturers. FDA advises feed manufacturers to recall finished feed that is made from AquaBond or Aqua-Tec II due to the estimated levels of melamine and related compounds in the finished products. FDA believes that no recall is warranted of the finished feed made from Xtra-Bond based on the estimated levels of melamine and related compounds in the finished product and based on currently available data and information.

The estimated melamine levels in feed made with these binding agents are similar to the levels discussed in the interim safety/risk assessment of melamine and related compounds made available by FDA earlier this month. In that assessment, federal scientists determined that, based on currently available data and information, the consumption of pork, chicken, domestic fish, and eggs from animals inadvertently fed animal feed contaminated with melamine and its analogues is very unlikely to pose a human health risk.

The interim safety/risk assessment concludes that in the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day contained melamine and the melamine compound cyanuric acid in equal amounts, the potential exposure is about 250 times lower than the dose considered safe. This is a large safety margin. Translated to consumption levels, this means that a person weighing 132 pounds would have to eat more than 800 pounds per day of food containing melamine and its compounds to approach a level of consumption that would cause a health concern.

FDA is encouraging domestic feed suppliers to be vigilant in quality control in their supply chain and to monitor for any improper additives, including melamine and its analogs.

The Tembec and Uniscope products also reportedly contain a urea formaldehyde resin-type ingredient, a raw ingredient used to make the binding agent in these products. FDA is investigating this use of the urea formaldehyde resin-type ingredient in the Tembec and Uniscope products, and will take appropriate regulatory action if warranted.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) today issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonaland pandemic use.

FDA's goal with the guidances is to outline the regulatory pathways for the rapid development and approval of these products.

"FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities."

In March 2006, FDA issued two draft guidance documents for public comment — one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent. The final guidances reflect publicinput, including vaccine companies and public health officials.

Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants).

The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza. Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator — such as immune response to the vaccine — to predict effectiveness, an approach that may reduce the vaccine's development time. Further clinical studies are then required to verify the vaccine's clinical benefit.

The guidances indicate that manufacturers should submit a new Biologics License Application (BLA) for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each pandemic and seasonal vaccine has its own trade name and labeling.

For companies with U.S. licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine in which the manufacturing process is the same as for the seasonal vaccine. For manufacturers developing vaccines using a new manufacturing process, both guidance documents explain the process for obtaining licensure using the accelerated approval pathway.

The guidance documents represent the FDA's ongoing efforts under its Critical Path Initiative to translate scientific advances, such as cell-culture derived and recombinant vaccine technologies, into new medical products with shorter approval timeframes.

For more information:

"Guidance for Industry, Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines"

"Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines"



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