FDA Alert News October 2007

FDA Alert News October 2007 - Food and drug administration press release for october 2007

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FDA Alert News October 2007
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Food and Drug Administration Press Releases

The U.S. Food and Drug Administration announced the approval of Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp,in children ages 4 years and older.

Tinea capitis most commonly affects children and is often characterized by severe itching, dandruff and bald patches. It is a persistent and contagious fungal infection that usually does not respond to topical treatment.

"Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread."

The FDA, in a pediatric written request, approached Novartis Pharmaceuticals Corporation of East Hanover, N.J., the manufacturer of Lamisil (terbinafine hydrochloride), for a formulation palatable for children. The company formulated the new dosage form, granules, which can be sprinkled on food.

Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to encourage drug manufacturers to conduct pediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for pediatric populations. The FDA may only grant a drug pediatric exclusivity if that drug meets specific requirements. The FDA makes a written request to the manufacturer or the company can prompt the agency to make a written request for pediatric studies.

"This is an important step in working with manufacturers to bring to market drug therapies that are formulated for, studied, and dosed in actual pediatric populations," said Dianne Murphy, M.D., director of the Office of Pediatric Therapeutics for FDA. "It is our hope that other drug manufacturers will study and devise therapies specifically for children."

The approved pediatric doses were determined through clinical trials in pediatric populations. Lamisil Oral Granules are approved to be administered once a day for six weeks. The actual dosage amount will be based on the weight of the child.

Additional Influenza Vaccine Approved for Upcoming Influenza Season

The U.S. Food and Drug Administration today approved Afluria, an additional seasonal influenza vaccine for the immunization of people ages 18 and older.

Afluria is intended to protect adults from influenza type A and type B flu viruses.  Influenza is a contagious respiratory illness that can cause annual epidemics.

The approval of Afluria, manufactured by CSL Limited of Parkville, Australia, brings the number of seasonal influenza manufacturers licensed for the U.S. market to six.

Based on current manufacturing trends, the Centers for Disease Control and Prevention estimates that the six manufacturers will supply a record 132 million doses of influenza vaccine for the 2007-2008 influenza season.

"Routine immunization is the most effective way to prevent influenza and decrease influenza-related complications which can include serious illness and death," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "The licensure of this additional manufacturer contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA's highest priorities."

Flu season in the United States can begin as early as October and can last as late as May, according to the CDC. Every year in the United States, more than 200,000 people are hospitalized with influenza and about 36,000 people die from its complications. While it is best to be immunized as soon as the vaccine is available, usually in September, getting a flu shot any time during influenza season is also appropriate because the influenza season often peaks late.

Afluria was approved using FDA's accelerated approval pathway for serious or life-threatening diseases, which reduces the time for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination. 

The most commonly reported adverse events were tenderness, pain, redness and swelling at the injection site, and headache, fatigue and muscle aches.

Afluria contains inactivated influenza viruses grown in chicken eggs. People who are allergic to eggs or any other component of the vaccine should not receive Afluria.

The vaccine is administered as a single injection in the upper arm, and is available in both a single-dose, preservative-free, pre-filled syringe and a multi-dose vial with thimerosal, a mercury derivative, as a preservative.

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products

The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other hydrocodone formulations, which have FDA approval.

Hydrocodone is one of the strongest medications available to treat pain or to suppress cough. The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products. As part of the drug approval process, the agency considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.

Some hydrocodone pain-relief products, such as Vicodin, are FDA-approved. However, most of the hydrocodone formulations now marketed to suppress coughs have not been approved. The agency is particularly concerned about improper pediatric labeling of unapproved hydrocodone cough suppressants (also known as antitussives), and the risk of medication error involving the unapproved products.

"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," said Steven K. Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research (CDER). "A case in point – no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age."

Today's action is part of FDA's broader initiative on marketed unapproved drugs that was announced in June 2006. At that time, the agency published a Compliance Policy Guide describing the FDA's risk-based enforcement approach to these products.

"This is another example of the kinds of safety risks that warrant priority enforcement under our Compliance Policy Guide," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "There are products on the market with inadequate safety information on their labeling improperly suggesting that the products may be used safely by very young children. In addition, these products may pose a higher risk of medication error than approved products. These products need to come off the market until they meet FDA approval standards."

There are a number of alternatives for patients who might be using unapproved hydrocodone cough suppressants. There are seven FDA-approved cough suppressant products containing hydrocodone. There also are a variety of approved antitussive products that do not contain hydrocodone. Consumers should consult a health care professional for detailed guidance on treatment options.

Anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007 and must cease further shipment in interstate commerce on or before March 31, 2008. Further legal action could be taken against those failing to meet these deadlines.

For more information:
Hydrocodone Drug Products Information

FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug

The Food and Drug Administration is alerting health care professionals and consumers to concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events.

Fentora, a potent opioid pain medication, is used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it. Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication on a less frequent basis.

The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

"FDA is monitoring this issue very closely," said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. "We are working with the manufacturer to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora."

In its Public Health Advisory and Health Care Professional Sheet published today, FDA warned physicians and other health care professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

Patients also must be under a doctor’s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.

On Sept.10, 2007, Cephalon Inc., the manufacturer of Fentora, sent letters to physicians and other health care providers advising them about the adverse events and deaths reported for Fentora. FDA is reviewing available information including adverse events. The agency has asked the company to strengthen warnings and improve the dosing instructions in the drug’s product labeling. FDA also requested that the company improve their education plan for prescribers and pharmacists on the proper patient selection, dosing instructions and restrictions on substituting Fentora for other products.

Adverse events related to this product should be reported to MedWatch, the FDA’s voluntary reporting program:
www.fda.gov/medwatch/report.htm
800-332-1088
Fax: 800-332-0178
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787

For more information, please visit: Fentanyl Buccal Tablets (marketed as Fentora)

Statement by FDA Commissioner Andrew C. von Eschenbach on Dr. Galson's Appointment

It is with great pride and admiration that I extend my congratulations to Dr. Steven Galson on his prestigious appointment to Acting Surgeon General, which begins October 1, 2007. As a Rear Admiral in the U.S. Public Health Service, Steven has a life-long commitment to the advancement of public health. Since joining FDA in 2001, he has provided exemplary leadership to one of FDA’s busiest centers—the Center for Drug Evaluation and Research. Because of his accomplishments, Americans have access to safer and more effective medical products than ever before. I know Steven will excel as our nation’s chief health educator and Americans will continue to benefit from his dedication to public service. As Steven transitions to his new role, I am appointing Dr. Janet Woodcock as Acting Center Director. Janet will retain her position as Deputy Commissioner and permanent Chief Medical Officer. In addition to assuming the day to day operational responsibilities of Center Director, she will work directly with me in immediately launching a national search for a permanent Center Director. I am indebted to her for one more demonstration of her dedicated service to the Agency, and I am extremely grateful for the support and commitmentof every member of CDER in this effort.

FDA Warns Consumers Not to Consume "Organic Pastures Raw Cream"

The U.S. Food and Drug Administration (FDA) is warning consumers not to drink or consume raw (unpasteurized) cream labeled as "ORGANIC PASTURES Grade A RAW CREAM" in one-pint plastic bottles coded "SEP 14" through "SEP21."

This product, marketed by Organic Pastures Dairy Company ("Organic Pastures"), Fresno, Calif., may be contaminated with Listeria monocytogenes, an organism which can cause a serious and sometimes fatal disease called Listeriosis in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeriosis can cause miscarriages and stillbirths among pregnant women.

The product was sold in retail stores throughout California and was also available worldwide via phone orders, and is not pasteurized. Pasteurization, a process that heats milk to a specific temperature for a set period of time, kills bacteria responsible for diseases such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria and brucellosisis. The California Department of Food and Agriculture issued an order to Organic Pastures on September 7 to withdraw the raw cream from retail distribution after routine product sampling at the facility detected the bacteria. As of September 20, 2007, the California Department of Agriculture has now permitted Organic Pastures to sell and distribute raw cream within the state of California.

FDA advises consumers to throw away product labeled as "ORGANIC PASTURES Grade A RAW CREAM" with code dates "SEP 14" through "SEP 21".

Individuals who have consumed Organic Pastures raw cream and who have experienced any of the symptoms described above should contact a doctor or other health care provider immediately.

No illnesses have been reported to date.

Consumers with questions may contact Mark McAfee, Chief Executive Officer/Founder of Organic Pastures, at 1-877-RAW-MILK (1-877-729-6455).

Statement by FDA Commissioner Andrew C. von Eschenbach on Passage of FDA Amendments Act of 2007 (FDAAA)

We at FDA are pleased that Congress has passed the FDA Amendments Act of 2007 and thank the Members of Congress and their staff for all their hard work onthis important accomplishment.

We are particularly pleased that Congress has completed the reauthorizations of the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA)--two programs accounting for nearly one quarter of FDA's annual budget. Over the past years, the PDUFA and MDUFMA programs have resulted in significant public health gains by making safe and effective, yet increasingly complex, medications and medical devices available to patients faster than was previously possible.

The legislation also includes the reauthorizations of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act--two statutes that have provided invaluable information to the agency about medical products' interaction with pediatric populations.

These programs are vitally important to the agency and its continued ability to protect and promote the public health.  We look forward to working towards implementation of this legislation.

FDA Warns Consumers about the Risk of Cryptosporidium Illness from Babys Bliss Gripe Water

The U.S. Food and Drug Administration (FDA) is warning consumers not to consume Baby’s Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as “10/08” on the label), distributed by MOM Enterprises, Inc., of San Rafael, Calif. FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.

The most common symptom of infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. While most people with healthy immune systems will recover without treatment, the infection could be serious or life-threatening for certain individuals. Infants, children and pregnant women are susceptible to dehydration resulting from diarrhea, which can be life-threatening. Individuals with weakened immune systems are also at risk for a more serious and life-threatening form of illness.

Parents of children who have recently consumed Baby’s Bliss Gripe Water, apple flavor, and have these symptoms should seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection.

Approximately 17,600 bottles of the product were distributed nationwide in retail stores and sold over the Internet between November 2006 and September 2007. A code of 26952V with an expiration date of 10/08 appears on the bottle’s carton. The product is sold in a four-ounce plastic bottle packaged inside of a cardboard carton which is labeled with the following: Baby’s Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething. Dietary Supplement. 4 fl. ozs. (120 ml). Ginger Extract. Fennel Extract. Other ingredients: Deionized Water, Vegetable Glycerin, Fructose, Natural apple flavor, Citric acid, Bioflavonoid Extract, and Grapefruit Seed Extract. Distributed by: MOM Enterprises, Inc., San Rafael, CA 94903 USA. FDA advises consumers to throw away bottles of the product described above that they have in their possession.

MOM Enterprises, Inc. is fully cooperating with FDA’s investigation into the cause of the contamination and is recalling all potentially contaminated products. FDA continues to investigate and will provide updates as more information becomes available. Consumers can call the FDA at 1-888-723-3366.

FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine

The U.S. Food and Drug Administration today proposed a change to its regulation on the use of chlorofluorocarbons or CFCs in metered dose inhalers (MDIs) for epinephrine. The rule would remove the “essential-use” designation that allows the use of CFCs in these medical devices.

Epinephrine MDIs are used for the temporary relief of occasional symptoms of mild asthma.

FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release CFCs. Under the proposed rule, epinephrine MDIs containing CFCs would be removed from the market by the end of 2010. A 60-day public comment period will commence following publication of the proposed rule in the Federal Register, and an open public meeting on the essential use of epinephrine will be held on a date to be announced later.

The Clean Air Act permits CFCs to be used in medical products, if the use is determined to be essential by FDA. The use of CFCs has been generally banned in consumer aerosols, such as hairspray, in the United States since 1978 because of adverse effects on stratospheric ozone levels.

The production of CFCs is being phased out worldwide under the terms of an international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer. Most MDIs available in the United States once contained CFCs; however most such products have recently been or are being reformulated to use other substances as propellants.

Epinephrine MDIs are the only devices currently marketed over the counter. Should this rule become final, epinephrine MDI users will have to obtain a prescription for alternative drug products if a non-CFC epinephrine inhaler still does not exist.

For more information, visit:
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

FDA Approves Nasal Influenza Vaccine for Use in Younger Children

The U.S. Food and Drug Administration today approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of 2 and 5.

Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49.

“The goal of preventing influenza is now more attainable with the availability of FluMist for younger children,” said Jesse L. Goodman, M.D., director, FDA’s Center for Biologics Evaluation and Research. “This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot.”

The U.S. Centers for Disease Control and Prevention recommends that all children age 6 months to 59 months receive a vaccination to protect against influenza. Studies have shown that children younger than 5 years had rates of influenza-associated hospitalizations similar to those among individuals age 50 through 64 years, emphasizing the need for improved influenza prevention efforts for this younger U.S. population.

However, until today, there have been only two vaccines licensed in the U.S. for children under the age of 5. One influenza vaccine, Fluzone, is indicated for people over 6 months of age, while another vaccine, Fluvirin, is available for use in children age 4 and older.

Approximately 6,400 infants and children age 6 months to 59 months received FluMist in three studies to support the vaccine’s safety and effectiveness. Two studies compared FluMist to placebo (no vaccine), both of which demonstrated the vaccine’s effectiveness in preventing influenza illness. A third study compared FluMist to an inactivated or “killed” seasonal influenza vaccine shot. The results showed that there were 53 cases of influenza disease among 3,900 children who received FluMist compared to 93 cases among the same number of children who received an inactivated or “killed” seasonal influenza vaccine shot. Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials.

Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children 2 to 6 years of age.

FluMist should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine. People who are allergic to any of FluMist’s components, including eggs or egg products, should also not receive the vaccine.

FluMist is manufactured by MedImmune Vaccines, Inc., Gaithersburg, Md. Fluvirin is made by Novartis Vaccines and Diagnostics Ltd, Liverpool, England. Fluzone is manufactured by sanofi pasteur Inc., Swiftwater, Pa.

FDA Appoints Cote to Head Orphan Products Development Office

The U.S. Food and Drug Administration (FDA) has named Timothy Coté, M.D., M.P.H., as the new director of FDA's Office of Orphan Products Development. Dr. Coté will be responsible for promoting the development of products that demonstrate promise for the diagnosis or treatment of rare diseases or conditions.

"We are very pleased to have Dr. Coté rejoin the FDA as the new head of the Orphan Products Development office," said Janet Woodcock, M.D. deputy commissioner for the FDA. "Tim brings a plethora of experience confronting emerging health issues in the United States and abroad, coupled with a commitment to public service."

Dr. Coté's experience ranges from medical epidemiology to clinical research.

Dr. Coté, a captain in the U.S. Public Health Service Commissioned Corps, most recently served as the Centers for Disease Control's (CDC) country director for the African nation of Rwanda. In Rwanda, he directed programs in HIV/AIDS, malaria and avian influenza, and was responsible for scientific and administrative leadership in patient care and research initiatives. He also oversaw the President's Emergency Plan for AIDS Relief (PEPFAR) operations in Rwanda. Under his leadership, the numbers of HIV-infected individuals receiving anti-retroviral medications from the United States rose from 20,000 to 55,000 persons.

Early in his career, he was a CDC Epidemic Intelligence Officer at the Maryland Health Department. He also served as a senior federal advisor for CDC at the District of Columbia Health Department. From February 2002 until August 2004 Dr. Coté was the chief of the Therapeutics and Blood Safety Branch in the FDA's Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology.

Dr. Coté has a bachelor of arts degree in biology and psychology from Syracuse University. He earned his medical degree from Howard University College of Medicine, and a masters in public health from the Harvard School of Public Health. Dr. Coté also volunteers as a general practitioner for the Spanish Catholic Center in Wheaton, Md.

For more information go to: www.fda.gov.

FDA Warns Procter and Gamble about Unlawful Marketing of Product for School Children

The U.S. Food and Drug Administration (FDA) today sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product.

The agency says the product’s claims and directions for use cause it to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. It cited specifically Procter & Gamble promotion of Early Defense for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours. Although FDA is not aware of significant health risks associated with Early Defense, the agency is concerned because this product has not been proven safe and effective for these claims.

“FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,” said Steven K. Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “Over-the-counter (OTC) drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”

Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugs’ labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed.

There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. In this case, the product's claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph. Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes these impermissible claims.

FDA regards compliance with its approval and monograph requirements to be integral to drug safety. Without the foundation of compliance, it is not possible to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs.

Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as injunctions against continuing violations and seizure of illegal products.For a copy of the warning letter, visit: http://www.fda.gov/foi/warning_letters/s6508c.htm

For more information on FDA’s Drug Safety Initiative, visit:
http://www.fda.gov/cder/drugSafety.htm

FDA Clears for Marketing First Rapid Test to Screen for Bacterial Contamination in Blood Platelets

The U.S. Food and Drug Administration has cleared for marketing the first rapid test to detect bacterial contamination in blood platelets prior to transfusion. 

The Platelet Pan Genera Detection (PGD) Test System is a disposable test strip for use in a hospital transfusion service setting. It is intended to supplement current quality control testing methods used by blood establishments following collection of platelets using an automated instrument.

“The clearance of a rapid test is a significant step in the detection of bacterial contamination of platelets for transfusion,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. “In half an hour, a sample is prepared, processed and read, providing an additional assurance that the product is free from harmful bacteria.”

Platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery, and in individuals who do not produce platelets. Patients who are transfused with platelets contaminated with bacteria are at risk of developing a serious and potentially life-threatening infection of the blood stream known as blood poisoning. Blood poisoning must be treated quickly to prevent the infection from spreading to the heart and lungs.

Bacterial contamination of platelets is the leading infectious cause of transfusion-related patient fatalities. The risk of a patient receiving a transfusion contaminated with bacteria is 1 in 5,000 -- far greater than the risk of transmitting hepatitis C virus (1 in 1.6 million) or HIV (1 in 1.9 million). To reduce the risk of transfusing contaminated platelets, blood centers culture samples of the platelets 24 hours after the donation. The culture is read within the next 24 hours (within 48 hours after the donation), and contaminated units are discarded. However, there is a possibility that the number of bacteria present at the time of culture may be so low that bacteria is not detected due to sampling limitations.   
 
Rapid testing of blood platelets using the Platelet PGD Test System permits units of platelets to be retested at a time closer to their use. Although the test system is less sensitive than standard cultures, it is done later in storage when bacteria, if present, have multiplied, and thus are easier to detect.

The Platelet PGD Test System was developed by Verax Biomedica Inc., Worcester, Mass.

FDA Clears Genetic Lab Test for Warfarin Sensitivity

The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be especially sensitive to the blood-thinning drug warfarin (Coumadin), which is used to prevent potentially fatal clots in blood vessels.

One-third of patients receiving warfarin metabolize it quite differently than expected and experience a higher risk of bleeding. Research has shown that some of the unexpected response to warfarin depends on variants of two genes, CYP2C9 and VKORC1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of both genes.

"Today’s action offers physicians the first FDA cleared genetic test for warfarin sensitivity, which is another step in our commitment to personalized medicine,” said Daniel Schultz, M.D., director, FDA’s Center for Devices and Radiological Health. “With this test, physicians may be able to use genetic information along with other clinical information to treat their patients.”

Warfarin can be a difficult drug to use because the optimal dose varies depending on many risk factors, including a patient's diet, age, and the use of other medications. Rapidly achieving the correct dose is important. Patients who receive doses that are higher than needed to correctly thin the blood are at risk of life-threatening bleeding. Those who receive doses that are too low may remain at risk of life-threatening blood clots.

Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.

In August, FDA approved updated labeling for Coumadin, the brand name version of warfarin, explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. Manufacturers of generic warfarin are adding similar information to their products' labeling.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients.

FDA cleared the test based on results of a study conducted by the manufacturer of hundreds of DNA samples as well as on a broad range of published literature. In a three site study, the test was accurate in all cases where the test yielded a result; 8 percent of the tests could not identify which genetic variants were present.

The new test was cleared for use on the Verigene System, a clinical laboratory test system. Both products are manufactured by Nanosphere Inc., Northbrook, Ill.

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD, to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a seven-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data.

"This study highlights one of AHRQ's most important missions:  to collect and analyze, scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ Director Carolyn M. Clancy, M.D. "This partnership with the FDA is a great way to move closer to answering important clinical questions that affect children and adults who have ADHD."

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class.

The analysis will take about two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions.

ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults.

Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs—Concerta, Strattera, and Adderall—ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated.  Adult use is also believed to be increasing.

In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. Drug manufacturers have created patient Medication Guides for individual products to help patients understand risks.
FDA and AHRQ recommend that individuals using or being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current health status, particularly for cardiovascular and psychiatric problems, including assessment for a family history of such problems.

For more information:

National Institute of Mental Health—ADHD page
www.nimh.nih.gov/healthinformation/adhdmenu.cfm

FDA News—ADHD Medications and Cardiovascular, Psychiatric Adverse Events
www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

AHRQ's Effective Health Care Program
www.effectivehealthcare.ahrq.gov

Food and Drug Administration Press Releases

The Alliance for Aging Research has chosen Janet Woodcock, M.D., FDA's deputy commissioner and chief medical officer, as the Indispensable Personof the Year for Health Research, for effective, innovative and ethical leadership.

Dr. Woodcock leads FDA's Critical Path Initiative, which is designed to improve the scientific bases for developing, evaluating, and manufacturing FDA-regulated products. In addition, she serves as the point person for a team of FDA scientists and policymakers who have been working on strategies to improve drug safety monitoring and the development pathway for treatments of disorders such as Alzheimer's disease that are associated with aging.

The Alliance presented the awards at its 14th Annual Bipartisan Congressional Awards Dinner earlier this month in Washington, DC.

A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award and other scientific awards, as well as six Special Citations from FDA Commissioners.

The Alliance is a nonprofit organization that promotes scientific and medical research for healthier aging.

For more information, visit: Consumer Update on Critical Path

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life. This action is being taken in response to concerns that the potency of the drug may deteriorate prior to its expiration date. The change will help improve the quality of the product so that consumers receive the level of medication needed to treat their thyroid disorders. Levothyroxine sodium products are used by over 13 million patients.

FDA is mandating that levothyroxine sodium drug products tighten their potency specifications to meet a 95 percent to 105 percent potency specification until their expiration date. The shelf life is the length of time a drug can be stored before it degrades to unacceptable levels. The 95 percent lower potency specification will ensure the drugs do not degrade by more than 5 percent of the labeled claim before their expiration date and the 105 percent upper specification is appropriate to address occasional analytical testing variability. Currently, these products are allowed a potency range of 90 to 110 percent.

The action is consistent with the recommendations of a joint FDA advisory committee and follows concerns expressed about levothyroxine sodium products by health care professionals and patients. Manufacturers and marketers have two years to comply with the revised specification.

A healthy, functioning thyroid gland is critical to regulating a person's overall metabolic function, which consequently impacts a host of other bodily functions. "These medicines are vital to people taking thyroid replacement or suppression therapies," said Janet Woodcock, M.D., deputy commissioner and chief medical officer and acting director of FDA's Center for Drug Evaluation and Research. "Tightening the potency specifications will ensure that the most vulnerable patients taking thyroid medication will receive the appropriate level of drug therapy needed for their condition." 

Consumers can also help maintain the potency of their medications by storing medications in a dry place at room temperature and avoiding humid, hot environments such as bathrooms, which speed deterioration.

Over the past decade, the FDA has spent considerable resources to ensure that levothyroxine sodium products are safe and effective. The FDA requested and received stability data from manufacturers of all the approved, marketed levothyroxine sodium drug products manufactured between July 2003 and June 2005, and examined the stability profile of each drug.

The data revealed a trend toward a loss of potency, with some preparations showing potency approaching 90 percent of labeled potency by the expiration date. Although all approved levothyroxine sodium products fall within the current potency specification of 90 percent to 110 percent, the stability data showed that some products rapidly degrade over their labeled shelf life. Some strengths or package types, such as blister packs, degrade more rapidly than others, resulting in varying expiration dates within product lines.  In addition, there is variability in expiration dating periods between products from different manufacturers. Some levothyroxine sodium tablets remain very stable, losing less than 5 percent of labeled potency within 24 months, while other products lost approximately 10 percent of labeled potency in 9 months. By tightening the potency specification and limiting the amount that products can degrade throughout their shelf life, FDA is reducing the variability in the stability profiles between products that could have clinical consequences in achieving target thyroid levels, especially for the most vulnerable patients, such as those with thyroid cancer. 

Levothyroxine sodium products have been marketed for decades in the United States.  This class of drugs is used to treat hypothyroidism, as a thyroid replacement therapy, to suppress the growth of benign goiters and thyroid cancer, and as an adjunct to surgery and radioiodine therapy designed to manage some types of thyroid tumors.

For more information:
http://www.fda.gov/cder/drug/infopage/levothyroxine/default.htm

FDA Takes Next Step in Transformation of its Center for Drug Evaluation and Research

The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.

The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.

The CPD contract runs through Sept. 20, 2009.

For more information

The Future of Drug Safety — Promoting and Protecting the Health of the Public
FDA's Response to the Institute of Medicine's 2006 Report http://www.fda.gov/oc/reports/iom013007.html#intro

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. Generic oxcarbazepine is FDA-approved for use alone or in combination with other medications in the treatment of partial seizures in adults and children aged four years and above.

"FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs. "The agency ensures that generic drugs are safe and effective, offering alternatives to Americans in choosing their prescription drugs."

Oxcarbazepine tablets in three strengths (150 milligrams, 300 milligrams and 600 milligrams) are manufactured by Roxane Laboratories Inc., Glenmark Pharmaceuticals Limited, and Sun Pharmaceutical Industries Limited.

The labeling of the generic products may differ from that of Trileptal because parts of the Trileptal labeling are protected by patents and/or exclusivity.

According to the publication Drug Topics, Trileptal was 74th best selling brand-name drug in by retail dollars in the United States in 2006.

Serious skin reactions have been reported in children and adults in association with Trileptal use. In the event a skin reaction should occur while taking Trileptal patients should immediately consult with their health care provider. Common side effects reported with Trileptal use include dizziness and drowsiness.

For information:

FDA Generic Initiative for Value and Efficiency
www.fda.gov/oc/initiatives/advance/generics.html

FDA's Office of Generic Drugs
www.fda.gov/cder/ogd/

Frequently asked questions about generic drugs
www.fda.gov/cder/consumerinfo/generics_q&a.htm

Food and Drug Administration Press Releases

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized on Tuesday approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.

Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension. These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site.

The agency takes seriously its responsibility to protect Americans from unapproved drugs. FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products' labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. Tuesday's action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.

The Complaint, filed by the U.S. Attorney's Office for the Southern District of Florida, charges the products are in violation of the drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.

Following an investigation of the firm's marketing practices, FDA officials advised FulLife that the claims related to prevention or treatment of diseases made these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, FDA inspectors found that the offending claims were still being made.

The seizure Tuesday at FulLife is the second such enforcement action in two months taken by FDA against dietary supplements being promoted with drug claims to cure or treat diabetes and other diseases or conditions.

On August 23, 2007, at the request of FDA, U.S. Marshals in the Northern District of Florida seized an estimated $41,000 worth of inventory of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules being promoted and distributed by Charron Nutrition of Tallahassee, Fla., for use in treating diabetes, arthritis, and other serious health conditions.

Food and Drug Administration Press Releases

Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health:

Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.

Defibrillators are life-saving products for patients with a heart rhythm abnormality. We know it can be frightening for a patient to learn that a product they rely on so much might have a serious defect. However, patients can be assured that the likelihood of fracture is very low and FDA is committed to ensuring that the risk to patients is minimized.

Background:

Today, Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today's action.

Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.

When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.

Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads.

FDA considers Medtronic's action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word "recall" to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.

The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic's recommendation that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.

Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.

Patients should recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients have reason to believe that they have a Sprint Fidelis lead or if they do not know the model of their lead, they should contact their health care professional.

FDA will continue to monitor information on these devices and will take whatever other actions may be necessary.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

Raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors, designed to interfere with the enzyme that HIV-1 needs to multiply. Raltegravir, sold under the trade name Isentress, received a priority review by the FDA.

“This is an important new product for many HIV-infected patients whose infections are not being controlled by currently available medications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

When used with other anti-HIV medicines, raltegravir may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight off other infections.

FDA’s approval of raltegravir is based on data from two double-blind, placebo-controlled studies in 699 HIV-1 infected adult patients with histories of extensive antiretroviral use. A greater proportion of the patients who received raltegravir in combination with other anti-HIV drugs experienced reductions in the amount of HIV in the blood, compared with patients who received placebo in combination with other anti-HIV drugs.

The most common adverse events reported with raltegravir were diarrhea, nausea, and headache. Blood tests also showed abnormal elevated levels of a muscle enzyme in some patients receiving raltegravir. Caution is advised when using raltegravir in patients at increased risk for certain types of muscle problems, including those who use other medications that can cause muscle problems.

Patients taking raltegravir may still develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV-1 infection. The long-term effects of raltegravir are not known, and its safety and effectiveness in children less than 16 years of age has not been studied.

Raltegravir also has not been studied in pregnant women. Women who are taking HIV medications when they get pregnant are advised to talk with their physician or other health care professional about use of this drug during pregnancy, and about registering with the Antiviral Pregnancy Registry if they use raltegravir.

Raltegravir is distributed by New Jersey-based Merck & Co., Inc.

Gerald F. Masoudi Named FDA Chief Counsel

Gerald F. Masoudi has been appointed as associate general counsel/chief counsel of the Food and Drug Division of the United States Department of Health and Human Services' Office of the General Counsel, which handles legal matters for the U.S. Food and Drug Administration.

Since 2005, Masoudi has been deputy assistant attorney general in charge of International, Policy and Appellate Matters in the Antitrust Division at the U.S. Department of Justice. From 2004-2005, he served as principal deputy associate general counsel for the Food and Drug Division, serving for a time as acting associate general counsel. Before joining the Food and Drug Division, Masoudi was a partner at Kirkland & Ellis LLP.

"We are pleased to have Jerry's expertise and insight back at HHS," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "His leadership and service will be critical to FDA's public health mission and regulatory responsibilities."

Masoudi earned his bachelor's degree from Amherst College in 1990. He graduated with high honors from the University of Chicago Law School in 1993, where he was an editor of the Law Review. He also clerked for Judge Frank H. Easterbrook of the U.S. Court of Appeals for the Seventh Circuit.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.

“This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

In several multi-center, multinational studies, doripenem was shown to have a cure rate comparable to the currently prescribed medications levofloxacin, for complicated urinary tract infections, and meropenem, for complicated intra-abdominal infections.

The most common adverse reactions reported were headache, nausea, diarrhea, rash, and phlebitis. In addition, allergic reactions have occurred and some may require immediate treatment.

The safety and effectiveness of doripenem injection in pediatric patients have not been established. Doripenem has not been studied in pregnant women, and the drug should be used during pregnancy only if clearly needed.

Doripenem injection is manufactured by Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, N.J.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.

In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.

The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.

A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.

Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.

Product Web sites, marketing and educational materials, and advertisements for PDE5 inhibitors will reflect the revised product labeling. The label revisions can be viewed at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.

For more information:
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm

FDA Expands Age Range for Use of Bacterial Meningitis Vaccine

The U.S. Food and Drug Administration today expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain. It can result in death or permanent injury to the brain and nervous system. In the United States, about 2,600 people become ill from bacterial meningitis annually. About 10 percent die from the infection and another 15 percent or so suffer brain damage or limb amputation.

Menactra was first approved by FDA in January 2005 for people ages 11 to 55 years. Previously, Menomune was the only meningococcal vaccine available in the United States for use in children, ages 2 years and older. Both products are manufactured by sanofi pasteur Inc. of Swiftwater, Pa. Both vaccines offer protection against four groups of Neisseria meningitidis, the bacterium that can cause meningitis.

“Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) currently recommends meningococcal vaccination for children ages 2 to 10 years who are at increased risk of developing meningococcal disease, such as those who have had their spleen removed or whose spleen is not functioning; those with a medical condition called terminal complement component deficiency which makes it difficult to fight infection; and those who expect to travel to areas outside of the United States where the disease is common. Vaccination also is used to control outbreaks of bacterial meningitis.

Menactra’s effectiveness was measured in clinical trials that included people ages 2 to 55 years. The vaccine was shown to produce an immune response one month after vaccination. The safety of Menactra was evaluated in eight clinical studies that included a total of 10,057 participants who received Menactra and 5,266 participants who received Menomune. The most common adverse events reported in the studies were pain at the injection site and irritability. Diarrhea, drowsiness, and lack of appetite also were common.

While not observed in these clinical trials, Guillain-Barré syndrome (GBS), a neurological disorder that causes muscle weakness, was noted as a possible but unproven risk in some adolescents following immunization with Menactra, occurring in an estimated 1 in 1 million vaccine recipients. As a precaution, people who have previously been diagnosed with GBS should not receive Menactra.

FDA and CDC will continue to monitor the safety of Menactra through their jointly administered Vaccine Adverse Event Reporting System.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).

The treatment, a protein that helps blood form the clots necessary to stop bleeding, can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerator-level temperatures for that storage length.

Approval of this change was based on stability data submitted by the company including laboratory tests of product potency conducted under different temperatures.
 
“The change in storage conditions will help patients, their families and treating physicians better manage the product, especially as part of medically supervised home treatment programs,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research.

Humate-P is approved for the treatment and prevention of bleeding in adult patients with hemophilia A, a rare clotting disorder. It is also approved for the treatment of spontaneous and trauma-induced bleeding and the prevention of excessive bleeding related to surgery in adult and pediatric patients with vWD, the most common inherited bleeding disorder in the United States.

Humate-P is manufactured from human plasma obtained from screened and tested U.S. donors.

Reported adverse reactions include allergic reactions such as hives, rash, chest tightness, swelling, and shock. Blood clots have been observed in patients under treatment for vWD.

Humate-P was first approved in 1986 for the treatment and prevention of bleeding in patients with hemophilia A. It was first approved for use in patients with vWD in 1999.

The product is manufactured by CSL Behring GmbH in Marburg, Germany.

Food and Drug Administration Press Releases

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.

Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The data also suggested that fewer patients receiving the drug experienced serious bleeding events.

This most recent data support the results from other comparison studies of Trasylol. The comparison studies were discussed at a September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees, which represent one part of FDA's oversight and review of drugs throughout their life cycles.

FDA anticipates further review of the risk and benefits of Trasylol, which may result in additional labeling or other regulatory action. FDA will work with the sponsor of the recently terminated study to evaluate the data fully.

In the meantime, FDA recommends that health care providers review the risks and benefits of Trasylol outlined in the label and in the Early Communication about an Ongoing Safety Review, and discuss the information with their patients.

In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

Trasylol is marketed by Bayer Pharmaceuticals Corp., Leverkusen, Germany.

This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews. Full text of the Early Communication about an Ongoing Safety Review can be found at http://www.fda.gov/cder/drug/early_comm/aprotinin.htm.



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