FDA Alert News April 2007

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Food and drug administration press release for april 2007

FDA Alert News April 2007
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FDA Press Release April 2007

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today notified Hill's Pet Nutrition, Inc., of Topeka, Kansas, that FDA testing has detected melamine and melamine byproducts in wheat gluten received by the company to make dry cat food. FDA is conducting an investigation into pet food products made with wheat gluten that contains melamine and their association with reports of injury and deathsin cats and dogs.

Because the cat food is sold exclusively through veterinarians, Hill's has notified veterinarians, and is voluntarily recalling the pet food containing the wheat gluten and will conduct its own testing.

Consumers who have any bags of Prescription Diet m/d Feline should discontinue use. They should speak with their veterinarian if their pet shows any signs of kidney/renal illness. Such signs include loss of appetite, lethargy and vomiting.

"FDA recognizes that pets are very important to the American people and our sympathies go out to those who have lost their beloved pets," said Stephen Sundlof, D.V.M., director of the Center for Veterinary Medicine, Food and Drug Administration.

During two months in early 2007, Hill's Pet Nutrition manufactured Prescription Diet m/d Feline using wheat gluten from the same company that has supplied wheat gluten to Menu Foods, Inc. Menu Foods, Inc. (menufoods.com/recall) has also voluntarily recalled products potentially contaminated with melamine. See http://www.fda.gov/oc/opacom/hottopics/petfood.html for more information on the pet food recall.

The Hill’s cat food now being recalled is labeled Prescription Diet m/d Feline dry food. The products are:

The agency is continuing to work with Menu Foods, Inc., and Hill's Pet Nutrition, Inc., to ensure the effectiveness of their recalls.

For more information, consumers may contact Hills Pet Nutrition at 1-800-445-5777 or visit www.HillsPet.com.

FDA Approves First Biologic to Treat Rare Clotting Disorder

The U.S. Food and Drug Administration (FDA) today licensed Ceprotin, the first biologic treatment for patients with a rare genetic defect that can cause apotentially life-threatening clotting disorder.

Ceprotin is made from the plasma of healthy human blood donors. It is a concentrated form of Protein C, a substance normally manufactured in the liver that circulates in the plasma in very small amounts. Protein C plays an important role in controlling blood coagulation by preventing the formation and growth of blood clots.

Severe congenital Protein C deficiency is a rare genetic defect found in one to two newborns for every million births. Patients with insufficient levels of Protein C experience abnormally high numbers of blood clots. Complete absence of the protein is fatal. Symptoms typically appear soon after birth. Clotting may occur in the blood vessels of the skin, eyes, brain, kidneys and throughout the body.

"This product offers much-needed treatment for the small number of patients with severe inherited Protein C deficiency," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. "If left untreated, clotting may result in blindness, severe brain damage, multi-organ failure and death for these patients."

Patients with severe inherited Protein C deficiency must take oral or injected anticoagulant drugs on a regular basis to avoid blood clots. Ceprotin is intended to treat these patients when they are faced with a life-threatening situation from blood clots in the veins, or a severe skin and systemic blood clotting disorder known as Purpura fulminans.

The company enrolled all available patients for the pivotal trial. In 94 percent of the patients studied for Purpura fulminans, Ceprotin was found "effective." In another 6 percent of patients, the treatment was found "effective with complications" because they required a dosage adjustment. Eighty percent of the treatments for blood clots in the veins were determined as "excellent" while the other 20 percent were determined as "good."

The seven patients who took Ceprotin as a preventive measure before surgery or anticoagulation therapy experienced no blood clotting complications. Eight patients who were given Ceprotin as a long term preventive measure did not experience the severe skin and blood clotting events associated with Purpura fulminans.

The most common adverse reactions were rash, itching and lightheadedness.

FDA granted Ceprotin orphan drug status, which provides the manufacturer with financial incentives to develop a drug or biologic to treat a rare disease (affecting fewer than 200,000 people in the United States). Since 1983, more than 200 drugs and biological products have been brought to market in this way.

FDA reviewed the drug’s Biologics License Application under a priority review schedule.

Ceprotin is manufactured by Baxter Healthcare Corp. of Deerfield, Ill. 

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketingof the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

"This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.

For more information, visit http://www.fda.gov/cder/drug/advisory/tegaserod.htm

FDA Announces Voluntary Withdrawal of Pergolide Products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments.

FDA Launches Web page Warning Against Buying Accutane And Its Generic Versions Online

The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online.  Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The Web page, http://www.fda.gov/buyonline/accutane, will be positioned as a search result on Google and other search engines when a consumer initiates an online search for the drug under any one of its four names (Isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem, Claravis, and Sotret.)  The web page warns that the drug "should only be taken under the close supervision" of a physician or a pharmacist, and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies.

"This Web page is yet another step we're taking to ensure the safe use of a drug that can provide significant health benefits when used properly, but that can also cause very serious side effects if used without supervision of a health professional," said Steven Galson, M.D.,M.P.H., Director, FDA's Center for Drug Evaluation and Research.

FDA and the manufacturers of isotretinoin have put in place special safeguards to reduce the risks of isotretinoin, including a strict distribution program, called iPLEDGE. The aim of the distribution program is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Isotretinoin is available only at a pharmacy that is registered for this distribution program. Additionally, the distribution program is designed to prevent the sale of isotretinoin over the internet. Dispensing must comply with the agency's risk management requirements.

FDA Warns Again About Arsenic in Mineral Water

The Food and Drug Administration (FDA) is re-issuing its warning to consumers not to drink "Jermuk" brand mineral water due to the risk of exposure to arsenic, a toxic substance and a known cause of cancer in humans. The agency is providing this information again to consumers due to an expansion of the recall initiated by the products' importers and distributors. "Jermuk" water is imported from Armenia and distributed under different labels in California.Five brands of these products have been recalled since March 7.

The latest recall, which was initiated on March 16 by the product's distributor, Andreas Andreasyan DBA Arnaz & Nelli Co., North Hollywood, CA., is for "Jermuk Natural Mineral Water Fortified with Gas from the Spring". This product is additionally labeled as "Produced by Sam-Har Co. Republic of Armenia" and "Exclusive Distributor in USA: Arnaz & Nelli Inc., CA 91605".

Although arsenic is a well known human poison, there is little chance that someone would become seriously ill after consuming the recalled products over a brief period of time (days to weeks). However, it is likely that the person would experience nausea, abdominal pain and possibly vomiting, which are indicators of arsenic toxicity.

FDA has sampled the contents of 500 milliliter (mL) green glass and/or plastic bottles of all of these brands and found they contained 454-674 micrograms of arsenic per liter of water. FDA's standard of quality for bottled water allows no more than 10 micrograms per liter.

The agency is investigating whether other bottle sizes or types of packaging contain similarly tainted products, and will continue working to remove all such bottled water from the market.

There have been no illnesses reported at this time. Consumers who drank this water and have concerns are encouraged to contact their health care provider.

FDA may provide additional updates as more information becomes available.

The following products were recalled on March 7:

FDA Finalizes Report on 2006 Spinach Outbreak

The Food and Drug Administration (FDA) and California's Department of Health Services (CDHS) today released a joint report on an extensive investigation into the causes of an E.coli O157:H7 outbreak last fall that was associated with contaminated Dole brand Baby Spinach and resulted in 205 confirmed illnesses and three deaths. The inquiry was conducted by the California Food Emergency Response Team (CalFERT), a team of experts from FDA's district office in San Francisco and CDHS. They were assisted by experts from the Centers for Disease Control and Prevention (CDC) and Animal and Plant Health InspectionService of the U.S. Department of Agriculture.

The investigators successfully identified the environmental risk factors and the areas that were most likely involved in the outbreak, but they were unable to definitely determine how the contamination originated.

"The probe was a notable effort by federal, state and local officials," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Applied Nutrition. "It yielded valuable information we can use to determine how best to reduce the likelihood of similar outbreaks."

The report describes the painstaking detective work of the investigators following the first reports from CDC in September 2006 of an apparent outbreak of E.coli O157:H7 linked to the consumption of bagged spinach. The probe initially focused on the processing and packaging plant of Natural Selection Foods, LLC in San Juan Bautista, CA, where the contaminated products had been processed.

The next focus of the inquiry was the source of the spinach in 13 bags containing E.coli O157:H7 isolates that had been collected nationwide from sick customers. Using the product codes on the bags, and employing DNA fingerprinting on the bacteria from the bags, the investigators were able to match environmental samples of E.coli O157:H7 from one field to the strain that had caused the outbreak. Potential environmental risk factors for E.coli O157:H7 contamination at or near the field included the presence of wild pigs, the proximity of irrigation wells used to grow produce for ready-to-eat packaging, and surface waterways exposed to feces from cattle and wildlife.

Because the contamination occurred before the start of the investigation, and because of the many ways that E.coli O157:H7 can be transferred -- including animals, humans, and water -- the precise means by which the bacteria spread to the spinach remain unknown.

FDA continues to work closely with its federal, state and local partners to keep produce safe from bacterial contamination. In August 2006, the agency announced an initiative called "Leafy Greens" that focuses attention on the produce, contamination agents, and other areas of potential public health concern associated with such products. Recently, FDA recently issued a draft final guidance, "Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables", which recommends measures to prevent microbial contamination during the processing of fresh-cut produce.

Earlier this week the agency explored issues involved in the safety of fresh produce in a public hearing held in California, and it plans to hold a similar hearing on April 13, 2007 in Maryland. The goal of both events is to solicit and share information about the recent outbreaks, the involved and associated risk factors, and measures the agency could adopt to advance the safety of fresh produce.

Although washing produce would not have prevented the recent E-coli outbreak involving spinach, washing can reduce the risk of contamination from some other causes. FDA advises consumers that all produce should be thoroughly washed before eating.

The report on the probe of the Dole spinach contamination, titled: Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach, is posted at http://www.DHS.ca.gov.

Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety

The U.S. Food and Drug Administration (FDA) recently submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act (PDUFAIV) after reviewing public comments.

PDUFA provides user fee funds, paid by brand drug and biotechnology companies that are added to appropriated funds to support the review of new human drugs. Since 1992, when PDUFA was first enacted, FDA has provided the public with 1,220 new drugs and biologics. The current user fee program is scheduled to expire on September 30, 2007.

"The reauthorization of this law plays a significant role in FDA's continued ability to make drug therapies available to the American public in a timely fashion without sacrificing the quality of approval decisions," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Our proposed recommendations for PDUFA IV aim to strengthen our drug safety system and upgrade resources to enhance FDA's information technology capability."

Key goals for PDUFA IV include placing PDUFA on a sound financial footing, enhancing premarket review, and creating a modern post-market drug safety system that follows products across their full life cycle.

FDA is also proposing $6.25 million in new user fees for a voluntary program to review direct-to-consumer television advertisements for accuracy and balance prior to airing. This new program would support 27 additional staff and would be phased in over five years.

The package delivered to Congress includes FDA's proposed changes to the bill, a letter spelling out the agency's review performance goals for fiscal years 2008 through 2012, and a performance goal letter detailing the agency's performance goals and procedures for direct-to-consumer television advertising over the same five-year period.

These documents were developed after reviewing public comments submitted to FDA following a January Federal Register notice and a public hearing held in February.

Most of the public comment supported PDUFA reauthorization and endorsed expanding the agency's post-market safety initiatives. However, the performance goal letter was modified in response to public comments.

The definition of a Type A meeting -- the most urgent meeting with FDA—was changed to include meetings about important safety issues and to commit to holding 90 percent of those meetings within 30 days of a request.

FDA also proposes revised language clarifying the agency's commitment to combine its current approach to collecting safety data with methods that actively seek information about medications and adverse events.

Under PDUFA IV, annual user fees would be increased to $392.8 million, an $87.4 million increase over PDUFA III.

The initial proposal was $37.9 million in program enhancements, including $29.3 million to hire an additional 82 employees for post-market safety activities, $4.6 million to draft guidance for FDA reviewers and industry and $4 million to move FDA towards an all-electronic drug review system. In addition, $17.7 million would be used to pay for salary and benefit increases; $11.7 million would pay increased rents and the costs of the agency's move to the new White Oak facility in Silver Spring, Md.; and $20 million would cover significant increases in FDA's drug review workload that were incurred but not compensated for under PDUFA III. Under the law these costs can be supported under PDUFA IV and these costs are expected to continue.

For more information, visit: http://www.fda.gov/oc/pdufa/default.htm

FDA Proposes New, Tougher Procedures for Membership on Advisory Committees

The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.

"FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees," said Randall Lutter, Ph.D., FDA's acting deputy commissioner for policy. "Today's draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process."

FDA currently screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, FDA may grant a waiver when certain criteria are met, such as when the need for an individual's expertise outweighs the potential for a conflict of interest.

The draft guidance document would replace guidance issued in 2000 on FDA Waiver Criteria (www.fda.gov/oc/advisory/conflictofinterest/intro.html). The 2000 guidance attempted to address the complex set of variables that can be applied in reaching a decision about an individual advisory committee participant. However, because of its complexity, FDA officials found it difficult to achieve consistent results that the public could readily understand.  

This new guidance (www.fda.gov/oc/advisory/waiver/coiguidedft.html) would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting. In addition to a more streamlined approach for considering who may participate in meetings, FDA would tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.

Financial interest means the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government's action on a particular topic. Financial interests screened include, but are not limited to, stock ownership, related research and consulting arrangements.

A notice will appear in the Federal Register soon. To submit electronic comments on the draft guidance, visit www.regulations.gov or www.fda.gov/dockets/ecomments. Written comments may be sent to: Division of Dockets Management (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number 2007D-0101.

Today's announcement is part of the agency's overall effort to improve its advisory committee process. As announced in January, FDA will be establishing a new advisory committee on how to improve FDA's communication policies and practices consistent with the best available and evolving evidence. In addition, the agency launched a Web page dedicated to improving recruitment of advisory committee members and enhancing public participation in the process. For more information, go to: www.fda.gov/oc/advisory/.

Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food. In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. Although the committees provide advice to the agency, their recommendations are not binding and FDA makes final decisions.

FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder

The U.S. Food and Drug Administration (FDA) today approved Soliris (eculizumab), the first product for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death. Soliris is classified as an Orphan Drug and is a new molecular entitycontaining an ingredient not previously marketed in the United States.

"This product is important in that it offers a treatment other than blood transfusion that may help this small population of patients who are often very ill," said Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research, FDA. "This approval is one of multiple examples of how the orphan products program can benefit the public health with urgently needed products that would otherwise not be commercially available."

PNH, which usually develops in adults, is a disease characterized by red blood cells that develop abnormally. Once the abnormal cells are present in the bloodstream, naturally occurring proteins (called the complement system) designed to destroy bacteria and other infection-causing organisms break these cells down. This leads to abnormally darkened urine and, more importantly, causes anemia. Depending upon the severity of the disorder, patients with PNH may have pain, fatigue and debilitating weakness, the need for frequent blood transfusions, blood clots, and life-threatening or fatal strokes, heart attacks and intestinal disease.

Soliris does not cure PNH, but treats the breakdown of red blood cells, the most common characteristic of PNH. Soliris acts to block the complement system activity, including the destruction of PNH red blood cells.

FDA based its approval on the company's randomized, double-blind, placebo-controlled clinical study of 87 patients with PNH and a series of other clinical studies. The controlled study showed that over a 26-week period half of the participants receiving Soliris had stabilization of blood hemoglobin concentrations compared with no stabilization among placebo-treated patients. Soliris-treated patients also required significantly fewer blood transfusions.

Soliris' blockade of the body's natural immune system increases the patient's susceptibility to certain serious infections, particularly meningococcal infections that can cause bacterial meningitis, an infection of the tissue surrounding the spinal cord and brain. Serious meningococcal infection was the most important adverse reaction experienced by patients who received Soliris in clinical studies. Because of the high risk for serious meningococcal infections, all 196 PNH patients in the clinical studies were vaccinated with a meningococcal vaccine; two of them developed meningococcal sepsis (an infection of the bloodstream caused by meningococcal bacteria) during treatment with Soliris.

A special risk management plan for Soliris has been developed to address the risk of serious meningococcal infection. The labeling of the product contains a boxed warning and requires that patients receive meningococcal vaccination prior to receiving Soliris. The labeling also includes a Medication Guide for patients. In addition, the risk management plan includes an educational program for physicians.

Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product. About one person out of a million people will be diagnosed with PNH.

Soliris is manufactured by Alexion Pharmaceuticals, Inc. (Cheshire, Ct.).

FDA Clears Rapid Test for Meningitis

The U.S. Food and Drug Administration (FDA) today cleared for marketing atest that uses molecular biology to quickly detect the presence of viral meningitis.

The Xpert EV test, when used in combination with other laboratory tests, will help physicians distinguish between viral meningitis and the less-common, but more severe, version of meningitis caused by bacteria.

Meningitis is an infection of the cerebrospinal fluid surrounding a person's spinal cord and brain, causing inflammation of the tissues in these areas. The illness is diagnosed by testing the fluid obtained from a patient during a spinal tap. Typically, diagnostic tests for meningitis can take up to a week to get results. But results from the Xpert EV test are available in two and one-half hours.

"Because this test is significantly faster than existing methods for diagnosing meningitis, it could minimize delays in treating patients. Swift recognition of the cause and appropriate treatment is critical to patient recovery," said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health. "Since bacterial meningitis can be deadly within as little as two days, patients who have viral meningitis are frequently treated with antibiotics as a safeguard against the more dangerous bacterial meningitis. This test should help physicians manage patients appropriately and prevent unnecessary treatment with antibiotics."

Knowing whether the meningitis is viral or bacterial is imperative to early effective treatment. But distinguishing between the two types of infection is difficult because of similar symptoms. Patients with viral meningitis usually recover within two weeks without any medical intervention. Bacterial meningitis, however, can lead to brain damage, hearing loss and even death if not treated properly.

For patients over two years of age, symptoms of meningitis include fever, severe headache, stiff neck, nausea, sleepiness, confusion, and sensitivity to bright lights or seizures. These symptoms may be absent or difficult to detect in newborns and small infants who may only appear slow or inactive, or be irritable, have vomiting or feed poorly.

The Xpert EV test is the first fully-automated medical diagnostic test that isolates and amplifies viral genetic material present in a patient's cerebrospinal fluid by a process called reverse transcription-polymerase chain reaction. The test identifies infection resulting from a class of viruses known as Enterovirus, which are responsible for approximately 90 percent of all viral meningitis cases.

The Xpert EV test is performed by adding the sample directly to a disposable, single-use cartridge. The cartridge is loaded into the GeneXpert DX instrument which then conducts all the necessary laboratory procedures in a one-step, easy-to-use format that helps minimize errors.

The accuracy of the Xpert EV test was confirmed in a multi-site study at six institutions. A total of 255 patient samples were tested and demonstrated that 96 percent of patients who tested positive did have viral meningitis, and that 97 percent of patients who tested negative did not have viral meningitis.

The Xpert EV test was developed by Cepheid, a company located in Sunnyvale, Calif.

FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has 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-hypnoticproduct, with no memory of the event.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.

Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.

Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

For more information on the sedative hypnotic products and sleep disorders, visit http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm;
www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.

FDA Approves Tykerb for Advanced Breast Cancer Patients

The Food and Drug Administration (FDA) today approved Tykerb (lapatinib), a new targeted anti-cancer treatment, to be used in combination with capectabine (Xeloda), another cancer drug, for patients with advanced, metastatic breast cancer that is HER2 positive (tumors that exhibit HER2 protein). The combination treatment is indicated for women who have received prior therapy with other cancer drugs, including an anthracycline, a taxane, and trastuzumab (Herceptin). According to the American Cancer Society, about 180,000 new cases of breast cancer are diagnosed each year. Approximately 8,000 to 10,000 women die from metastatic HER2 positive breast cancer each year.

Tykerb, a new molecular entity (NME), is a kinase inhibitor working through multiple pathways (targets) to deprive tumor cells of signals needed to grow. Unlike, for example, trastuzumab — a monoclonal antibody, which is a large protein molecule that targets the part of the HER2 protein on the outside of the cell — Tykerb is a small molecule that enters the cell and blocks the function of this and other proteins. Because of this difference in mechanism of action, Tykerb works in some HER2 positive breast cancers that have been treated with trastuzumab and are no longer benefiting.

"Today's approval is a step forward in making new treatments available for patients who have progression of their breast cancer after treatment with some of the most effective breast cancer therapies available," said Steven Galson, MD, M.P.H., Director of FDA's Center for Drug Evaluation and Research. "New targeted therapies such as Tykerb are helping expand options for patients."

The approval of Tykerb was based on a randomized clinical trial in about 400 women with advanced or metastatic breast cancer that was also HER2 positive. In the trial, half the patients received Tykerb with capecitabine and half received capecitabine alone. Compared to patients receiving capecitabine alone, the group of patients receiving Tykerb with capecitabine had a statistically significant improvement in the time to tumor progression. In addition, the tumor response rate was higher in the group of patients receiving Tykerb with capecitabine (24 percent vs. 14 percent). The survival data are not yet mature.

The most commonly reported Tykerb-related side effects included diarrhea, nausea, vomiting, rash and hand-foot syndrome which may include numbness, tingling, redness, swelling and discomfort of hands and feet. Generally reversible decreases in heart function (that can lead to shortness of breath) have also been reported in a small percentage of patients. Patients should talk to their doctor about potential side effects, potential drug interactions, and other medical conditions including heart and liver problems. Tykerb is available in tablets of 250 mg. An undivided dose of 1,250 mg should be taken orally once daily for 21 days and in combination with capecitabine on days 1-14 of a 21 day cycle.

Tykerb will be distributed by GlaxoSmithKline, of Research Triangle Park, North Carolina.

FDA Proposes to Allow the Use of Alternative Temperature-Indicating Devices for Processing Low-Acid Canned Foods

The Food and Drug Administration (FDA) today issued a proposed rule which, if finalized, would benefit both consumers and the food industry by enabling manufacturers of heat-processed low-acid canned foods to modernize their equipment by using alternative temperature-indicating devices (TIDs). Under the proposal, these devices, which are the state-of-the-art equipment for measuring and recording temperatures, may be used instead of, or in addition to, conventional mercury-in-glassthermometers (MIGs).

If finalized, the proposed rule would amend FDA's current regulations for the processing of low-acid canned foods such as beans, corn, peas, and potatoes, and clarify such requirements as recordkeeping and the rules for measuring and recording temperatures during processing. The proposal also includes metric equivalents of avoirdupois (U.S.) measurements.

"This proposal is designed to benefit both consumers and the food industry," said Robert E. Brackett, Ph.D., director of FDA's Center for Food Safety and Nutrition. "It enables manufacturers to rapidly adopt technologically advanced temperature-indicating devices. And we believe that the proposed rule, after being finalized, would ensure that these devices are accurate."

The agency will allow low-acid canned food manufacturers who follow the proposed rule to change immediately from the currently required MIGs to alternative TIDs. Although these TIDs remain out-of-compliance until the proposal is finalized, FDA will consider, on a case-by-case basis, exercising its enforcement discretion if the new devices are used in a manner consistent with the proposed rule. Processors who choose this option must comply with any revised requirements when the final rule becomes effective.

FDA is providing a 90-day comment period on the proposed rule. Interested persons can submit comments electronically to http://www.fda.gov/dockets/ecomments or in writing to the Division of Dockets Management Branch (HFA-305), 5630 Fishers Lane, room 1061, Rockville, MD 20852. Submitted comments should be identified by Docket Number 2007N-0026.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) today warned consumers not to use American Bullie A.B. Bull Pizzle Puppy Chews and Dog Chews manufactured and distributed by T.W. Enterprises, Ferndale, WA, because they have the potential to be contaminated with Salmonella, which can cause serious infections in dogs and cats, and, if there is cross contamination, in people, especially children, the aged, and people with compromised immune systems. Consumers who have the pet treats manufactured or distributed by T.W. Enterprises listed below should not feed them to their pets, but instead dispose of them in a safe manner (e.g.,in a securely covered trash receptacle).

Salmonella can potentially be transferred to people handling these pet treats, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcareproviders.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Well animals can be carriers and infect other animals or humans. If your pet has consumed the recalled product andhas these symptoms, please contact your veterinarian.

The products covered by this alert include all sizes and lots of:

American Bullie A.B. Bull Pizzle Puppy Chew and Dog Chew (made from all American beef pizzle)

Following is a list of the affected products:

FDA collected samples of packages of three different sizes of bull pizzle (beef) dog chews manufactured by T.W. Enterprises and, after analysis, found Salmonella in one of them. FDA is including in its alert all sizes and all lots of bull pizzle chews manufactured by T. W. Enterprises because pizzles used in manufacturing the chews are processed at the same time, cut into chews of the desired sizes, and then packaged for sale. Differently sized chews are thus obtained from the same batch or lot of pizzles and manufactured under conditions that facilitate cross-contamination within batches or lots. It is impossible to differentiate chews manufactured by T. W. Enterprises by lot or batch numbers or dates of manufacture because packages of the firm’s chews are not coded with batch or lot numbers, and do not specify the dates of manufacture or bear expiration dates.

FDA is actively investigating this matter to determine the source of this problem, and will issue future updates as appropriate.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) is urgently reminding the public that contact with baby turtles can pose a serious health risk to infants, small children, and adults with impaired immune systems as they can be natural hosts to Salmonella, a group of bacteria that can cause severe illness and death. Recently, a four-week old infant in Florida died of infection traced to Salmonella pomona,a bacteria that was also found in a pet turtle in the home.

Salmonella is the genus name of a number of bacteria commonly associated with food poisoning from contaminated or undercooked foods, and salmonellosis is the disease the bacteria can cause. Salmonella can be found on the outer skin and shell surfaces of the turtles causing salmonellosis for those handling turtles without properly washing their hands after handling the animals.

FDA is reminding parents and others who care for children of the following:

In the early 1970's, it was determined that pet turtles, particularly red-eared sliders, were responsible for an estimated 280,000 cases of salmonellosis each year in the United States. In 1975, FDA banned the sale of turtles with a shell less than four inches long as a necessary public health measure. FDA has repeatedly emphasized the risks of turtle-associated salmonellosis because of a resurgence in the sales of such turtles in the last four years. The public health impact of turtle-associated salmonellosis in humans is an estimated74,000 cases in the United States per year.

Salmonella infection can be transmitted either directly from contact with the turtle or its feces, or indirectly through the animal's water. Turtles with Salmonella usually do not appear to be sick. Their feces do not always contain the bacteria, therefore a single negative test does not prove they are Salmonella-free.

Although anyone can acquire a salmonellosis infection, the risk is highest in infants, young children, the elderly, and others with lowered natural resistance to disease. Pregnancy, cancer, chemotherapy, organ transplant, diabetes, and liver problems pose particular risks. Gastrointestinal symptoms following Salmonella exposure begin in 6 to 72 hours (usually 12 to 36 hours) and generally last for two to seven days.

For more information on FDA's regulation of turtles, please see the following: http://www.fda.gov/cvm/turtleregs.htm.

FDA Provides Web Access to Information on Post-Approval Device Studies

The U.S. Food and Drug Administration (FDA) today unveiled a new Web page that will keep the public informed about the status of post-approval patientstudies for certain recently approved medical devices.

"FDA is committed to improving its medical device safety program and ensuring that medical devices remain safe and effective once they are in the hands of health professionals and the public," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "Electronic access will give the public an opportunity to see progress being made on a company's post-market commitments."

Modern devices provide significant health benefits, but experience has shown that the full magnitude of some potential risks doesn't always emerge during the mandatory clinical trials that are required for approval. FDA sometimes orders post-approval studies to address remaining issues such as the product's performance once it becomes more widely available or is used over a longer period of time.

Generally, companies must submit interim post-approval study status reports every six months for the first two years of the study and annually thereafter until the final report has been submitted.

FDA's new Web page includes information on all post-approval device studies ordered by FDA since Jan. 1, 2005. Each listing includes the company's name, the product's name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. No information on clinical data is available because the studies may be ongoing and include personal and confidential information. There are currently more than 40 listings on the Web page.
 
The Institute of Medicine called for public reporting of post-market studies in a 2005 study on pediatric devices. That same year, FDA initiated an internal review of its ability to monitor post-approval studies. As a result, the agency shifted responsibility for tracking these studies from its pre-market staff to its post-market staff and set up a new electronic system for them to doso.

In December 2006, FDA disclosed plans for the new Web page in a guidance document on how to report post-approval studies. In January 2007, FDA began discussingthe status of ongoing studies at its advisory committee meetings.

Improved communication about post-approval studies is just one of FDA's many efforts to strengthen post-market device safety. FDA is currently implementing an ambitious action plan drawn up last year by a Post-market Device Transformation Leadership Team – a group of experts drawn from both inside and outside of FDA.  Their action items included: pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime, mandatory use of electronic reporting for required adverse event reports and revising the Center for Devices andRadiological Health's current system of adverse event reporting.

The new Web page is available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm.

For more information on FDA's post-market action plan consult: www.fda.gov/cdrh/postmarket/mdpi.html.

FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients

The U.S. Food and Drug Administration (FDA) today announced the approval of HepaGam B for the prevention of hepatitis B reinfection in certain liver transplant patients. HepaGam B is the first product of its kind (an immune globulin product)approved for this purpose.

Hepatitis B is a serious disease caused by a virus that attacks the liver and can cause lifelong infection, liver cancer, liver failure and death. Liver transplant patients who have already been exposed to the hepatitis B virus (HBV) are at an increased risk of reinfection because they have weakened immune systems.

"This approval provides a new treatment option for the reduction of hepatitis B recurrence in liver transplant patients with a prior history of this serious disease," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "It is the first immune globulin product--one of several classes of proteins derived from human plasma--approved for this use."

HepaGam B works by providing an immediate immune response to the virus. This immunity protects patients previously exposed to HBV. Patients must receive injections at the time of their liver transplant and throughout their lives. This product is manufactured from human plasma collected at U.S. licensed plasma centers from healthy donors.

FDA based its approval on the company's clinical data in a study of HBV-infected persons undergoing full liver transplants, which showed a reduction in the virus recurrence rate from 86 percent to about 13 percent. Adverse reactions were similar to other immune globulin products for other indications and included headache and hypertension.

In January 2006, FDA licensed HepaGam B to prevent infection with HBV for the following other purposes: after acute exposure to blood or certain body fluids containing HBV; perinatal exposure of infants to mothers previously exposed to HBV; sexual exposure to persons previously exposed to HBV; and household exposure to persons with acute HBV infection.

HepaGam B is manufactured by Cangene Corp. of Winnipeg, Canada.

FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide

As part of the Food and Drug Administration's (FDA) on-going initiative to ensure that all marketed U.S. drugs have required marketing approval, the agency announced today that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide,T-Gen, Trimazide, and Trimethobenz.

FDA urges consumers who are using suppositories containing trimethobenzamide, and who have questions or concerns, to contact their health care provider. There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today's action.

"FDA is continuing its work to remove unapproved drugs from the market," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is committed to ensuring that the medicines Americans rely on when they are sick are proven to be effective and safe."

The Federal Register notice http://www.fda.gov/OHRMS/DOCKETS/98fr/78n-0224-nwl0002.pdf which outlines the agency's order to manufacturers and distributors, also concludes all outstanding issues for drugs containing trimethobenzamide, under the Drug Efficacy Study Implementation program (DESI). In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that drugs be shown to be effective, as well as safe. Under DESI, FDA evaluated the evidence of effectiveness for thousands of drug products previously approved for safety only, including those products marketed under the name of Tigan containing trimethobenzamide.

Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today's notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful.

"Prescription drugs that have not gone through the FDA approval process are of unproven safety and effectiveness," said director of CDER's Office of Compliance, Deborah M. Autor. "Today's action helps ensure that health care providers prescribe, and consumers take, only medicines shown to be effective."

Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. A small amount of these products will still be available in pharmacies after that date until supplies are exhausted. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing.

This action is the next step in a concerted FDA effort to ensure that all marketed U.S. drugs have required FDA approval. In June of last year, FDA announced its renewed emphasis on this issue and sent a clear signal to industry that FDA expects all marketed drugs to have required FDA approval, and that the agency will take action to make that happen. At that time, FDA published a Compliance Policy Guide or CPG, which is a guidance document that describes the agency's risk-based enforcement approach to marketed unapproved drugs. Completing DESI proceedings is a separate but important part of tackling the unapproved drugs problem.

For additional information regarding FDA's Unapproved Drugs Initiative visit http://www.fda.gov/cder/drug/unapproved_drugs.

Food and Drug Administration Press Releases

The Food and Drug Administration (FDA) will hold a public hearing on June 12 and 13, 2007, to obtain feedback on FDA's Medication Guide program. Medication Guides are handouts given to patients by pharmacists each time certain prescription drugs and biological products are dispensed. Medication Guides containFDA-approved patient information that could help prevent serious adverse events.

The goals of the public hearing include assessing the effectiveness of Medication Guides in communicating the risks of certain drug and biological products to consumers and identifying Medication Guide distribution challenges and solutions.

"We want to hear from manufacturers, distributors, pharmacies, health professionals, and patients about what concrete steps can be taken to ensure that consumers get the information they need to make informed decisions about the use of medicines," said Paul Seligman, M.D., Associate Director for Safety Policy and Communication at FDA's Center for Drug Evaluation and Research.

Under current rules (21 CFR part 208), Medication Guides are required if the FDA determines that the drug product has one or more of the following characteristics:

  1. It is one for which patient labeling could help prevent serious adverse effects.
  2. It has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients' decisions to use, or continue to use, the product.
  3. The product is important to health and patient adherence to directions for use is crucial to the effectiveness of the drug.

In recent years, FDA's efforts to improve risk communication have included an increase in the number of Medication Guides. There are approximately 240 products with Medication Guides. In addition, it has become more common for Medication Guides to be required for entire classes of drugs (such as non-steroidalanti-inflammatory drugs, or NSAIDs).

The public hearing will be held on June 12 and 13, 2007, from 8:30 a.m. to 4:30 p.m. each day at the National Transportation and Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW, Washington, DC 20594 (Metro: L'Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines).

A notice announcing the meeting, providing registration details, and describing procedures for submitting comments was published in the Federal Register on April 9, 2007. For more information on the meeting, including a link to the Federal Register Notice, please go to http://www.fda.gov/cder/meeting/medication_guides_200706.htm.

For additional information on Medication Guides, please go to http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

FDA Warns Consumers That Retailers May Still Have Recalled Pet Food on Shelves

FDA is advising pet owners that recalled pet food may still be on the shelves in some retail establishments. FDA urges retailers across the country to be vigilant in removing all products associated with the pet food recall, which began on March 16, 2007.

To verify the effectiveness of the recall, FDA has conducted approximately 400 checks of retail stores across the country. Based on the checks, FDA believes most companies have removed the recalled product; however, some have not. FDA will continue to monitor retailers’ efforts to remove these items from the shelves.

“FDA’s priority is to make sure that cats and dogs have safe food to eat, said Stephen Sundlof, D.V.M., director of FDA’s Center for Veterinary Medicine.” Many of us are pet owners and animal lovers, and we want pet owners to feel assured that we are doing everything we can to make sure that all contaminated food is off the shelves.”

In related news, Menu Foods, Inc., a private label manufacturer based in Streetsville, Ontario, Canada, expanded its recall on Tuesday, April 10, to cat food not previously subject to the recall. The varieties of cat food in the United States and Canada now being recalled are included in the list at the bottom of this news release. A complete list of Menu Foods' recalled products, including the new items, can be reviewed at www.menufoods.com.

The company acted after receiving information from FDA, which had confirmed test results it received from a laboratory at University of California, Davis. The UC-Davis lab found that canned cat food which had not been included in Menu Food’s earlier recalls tested positive for melamine, a chemical used as a fertilizer and in the manufacture of cutlery and kitchenware.

The company informed FDA that it had shipped wheat gluten purchased from China and contaminated with melamine from its Emporia, Kansas plant to its plant in Streetsville. Some of the products produced with the contaminated wheat gluten also were shipped to the United States. FDA investigators and officials with the Canadian Food Inspection Agency were in the Ontario facility on April 11.

Since March 16, recalls of pet food products, including certain varieties of dog food, have been conducted by Menu Foods, Inc., Hill’s Pet Nutrition, P&G Pet Care, Nestle Purina PetCare Company, Del Monte Pet Products, and Sunshine Mills, Inc. Extensive information about the current pet food situation can be found at the FDA Web site. There is now a single list of all recalled pet food located at http://www.fda.gov/ora/fed_state/recalls/Recall.xls which will be updated with any new recall information when announced. [Note: Excel documents can be read with a free copy of Microsoft's Excel viewer .]

LIST OF NEWLY RECALLED PRODUCTS:

Cat Food

 

 

 

 

 

 

 

 

 

 

Brand

Look For This Date on The Bottom of Can or Back of Pouch

Variety Description

Can / Pouch

Size

UPC

 

 

 

 

 

 

Americas Choice, Preferred Pet

 

 

 

 

Jan/2/10

Flaked Tuna 3oz

Can

3oz

54807-59114

 

 

 

 

 

 

Your Pet

 

 

 

 

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

72036-29026

 

Jan/24/10

 

 

 

 

 

Nov 06 09

Sliced Variety Pack 3oz

Can

3oz

72036-40013

 

 

 

 

 

 

Pet Pride

 

 

 

 

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

11110-86264

 

Jan/24/10

 

 

 

 

 

Nov 06 09

Sliced Variety Pack 3oz

Can

3oz

11110-86003

 

Dec 05 09

 

 

 

 

 

Dec 06 09

 

 

 

 

 

Jan 23 10

 

 

 

 

 

Jan 24 10

 

 

 

 

 

 

 

 

 

 

Laura Lynn

 

 

 

 

 

Jan/2/10

Flaked Tuna 3oz

Can

3oz

86854-02407

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

86854-02406

 

 

 

 

 

 

Nutriplan

 

 

 

 

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

41130-06755

 

 

 

 

 

 

Price Chopper

 

 

 

 

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

41735-12828

 

 

 

 

 

 

Publix

 

 

 

 

 

 

Jan/2/10

Flaked Tuna 3oz

Can

3oz

41415-08327

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

41415-08827

 

Jan/2/10

 

 

 

 

 

Jan/24/10

 

 

 

 

 

 

 

 

 

 

Stop & Shop Companion

 

 

 

 

Jan/2/10

Flaked Tuna 3oz

Can

3oz

88267-00286

 

 

 

 

 

 

Winn Dixie

 

 

 

 

 

Dec/19/09

Sliced Beef/Gravy 3oz

Can

3oz

21140-19419

 

 

 

 

 

 

Nutro Products

 

 

 

 

 

All Dates

Chicken Cacciatore 3oz

Can

3oz

79105-35205

 

All Dates

Orleans Seafood Jambalaya 3oz

Can

3oz

79105-35206

 

All Dates

Beef Ragout 3oz

Can

3oz

79105-35207

 

All Dates

Alaskan Halibut/Rice 3oz

Can

3oz

79105-35221

 

All Dates

Kitten Chicken/Lamb 3oz

Can

3oz

79105-35202

 

All Dates

California Chicken 3oz

Can

3oz

79105-30011

 

All Dates

Lamb/Turkey Cutlets 3oz

Can

3oz

79105-30014

 

All Dates

Salmon/Whitefish 3oz

Can

3oz

79105-30013

 

All Dates

Beef/Egg 3oz

Can

3oz

79105-30015

 

All Dates

Turkey/Chicken Liver 3oz

Can

3oz

79105-30016

 

All Dates

Seafood/Tomato/Bisque 3oz

Can

3oz

79105-30017

 

All Dates

Hunters Stew with Duck 3oz

Can

3oz

79105-30018

 

All Dates

Hunters Stew with Venison 3oz

Can

3oz

79105-30019

 

Food and Drug Administration Press Releases

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

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:

Food and Drug Administration Press Releases

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.

Food and Drug Administration Press Releases

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.

Food and Drug Administration Press Releases

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/.

Food and Drug Administration Press Releases

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.

Food and Drug Administration Press Releases

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.

Food and Drug Administration Press Releases

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.

Food and Drug Administration Press Releases

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