FDA Alert News September 2007

FDA Alert News September 2007 - Food and drug administration press release september 2007

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FDA Alert News September 2007
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FDA Approves Second West Nile Virus Screening Test for Donated Blood and Organs

The U.S. Food and Drug Administration today announced approval of a secondtest for the detection of West Nile virus (WNV) in blood and organs.

The cobas TaqScreen WNV test is an automated test that's able to detect the genetic material of the virus itself early in the infection. Such nucleic acid testing improves blood and organ safety, detecting whether donated blood and organs have been infected even before the donor's body has begun to produce antibodies against the virus.

Most often, WNV is transmitted to humans by mosquitoes. But WNV can also be transmitted by blood transfusion or organ transplantation from infected donors. While WNV infection is common in Africa, Asia, and the Middle East, it did not appear in the United States until 1999. Since then, WNV has become endemic in most of this country, with from 1 million to 3 million cases between 1999 and 2006, according to the Centers for Disease Control and Prevention.

"This action is the culmination of the dedicated efforts of FDA, our sister agencies, blood establishments, and manufacturers to bring donor screening tests to market for this increasingly common virus," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "As a result, blood centers and hospitals now have a choice of two FDA approved tests to screen for West Nile Virus in donated blood and organs."

Most people infected with WNV show no signs of the disease but about 1 in 150 to 1 in 350 infected people will develop serious symptoms, including encephalitis, an inflammation of the brain. Since the introduction of the virus, the reported number of human cases of serious WNV in the United States has grown steadily from 62 in 1999 to 4,269 in 2006.

WNV has been especially virulent this year. Although it is still early in the WNV season, 58 blood donors who are possibly positive for the virus have been reported to the CDC as of August 21, 2007.

The cobas TaqScreen WNV test is approved for the detection of the virus in plasma specimens from human donors of whole blood and blood components (plasma, red or white cells, platelets) and living donors of cells, reproductive cells and other tissues. It is also intended for use in testing plasma specimens of organ donors when specimens are obtained while the donor's heart is still beating. The test is not intended for use on samples of cord blood or as an aid in the diagnosis of WNV infection.

Approval comes as FDA is preparing guidance on the use of licensed WNV screening tests for blood donors.

The test is manufactured by Roche Molecular Systems Inc. of Pleasanton, Calif.

FDA Approves Human Thrombin for Topical Use in Surgery

The U.S. Food and Drug Administration approved Evithrom (human thrombin),a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

"The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc., Somerville, N.J.

Mars Petcare US, Inc. Recalls Dry Dog Food

The U.S. Food and Drug Administration is alerting consumers that Mars Petcare US, Inc. has recalled two dry dog food products because of the potential contaminationwith Salmonella Schwarzengrund.

The Mars Petcare US, based in Franklin, Tenn. is voluntarily recalling five-pound bags of Krasdale Gravy dry dog food sold in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania, and 50-pound bags of Red Flannel Large Breed Adult Formula dry food sold in Pennsylvania.

The FDA conducted tests on 10 samples, representing seven product brands from the company. Each sample (same size and brand of product) consisted of 15 subsamples, for a total of 150 subsamples. Tests of the 150 subsamples revealed two positive samples; one from the Krasdale Gravy dry food and another from Red Flannel Large Breed Adult Formula dry food.

Salmonella can potentially be transferred to people handling pet food, especially if they have not thoroughly washed their hands after having contact with the product or any surfaces exposed to the product. To date, there have been 64 cases of illness in humans related to Salmonella Schwarzengrund reported to the U.S. Centers for Disease Control and Prevention (CDC); however, none of the reported cases have been directly linked to the recalled product that was tested. The FDA is working with local and state officials, and with officials at the CDC in the investigation.

Here is identification information on the recalled products:

Product: Krasdale Gravy dry dog food
Size: Five-pound bag
UPC Code: 7513062596
Best By Date: July 16, 2008 & July 17, 2008
Best By Date Location: Back of bag
Distribution: Stores in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania

Product: Red Flannel Large Breed Adult Formula dry dog food
Size: 50-pound bag
UPC Code: 4286900062
Best By Date: July 12, 2008
Best By Date Location: Back of bag
Distribution: Stores in Reedsland and Richlandtown, Pa.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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 and has these symptoms, please contact your veterinarian.

Consumers with questions about the recalled product should call Mars Petcare US, Inc. at 866-298-8332.

For more information:
Safe Handling Tips for Pet Foods and Treats

Mars Petcare Pet Food Recall Questions andAnswers

Firm Release on Select Red FlannelLarge Breed Adult Formula Dry Dog Food (Aug. 21)

Firm Release on Select KrasdaleGravy Dry Dog Food (Aug. 21)

PennsylvaniaDepartment of Health Press Release (Aug. 10)

FDA Proposes New Rule for Sunscreen Products

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC)sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

Written submissions can be submitted by fax or mail:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax: 301-827-6870

For more information:
FDA Web site for Sunscreen Proposed Rule

Consumer Article: FDA Aims to Upgrade Sunscreen Labeling

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents

The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.

“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”

The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.

Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.

The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.

For more information:

FDA Office of Pediatric Therapeutics
www.fda.gov/oc/opt/default.htm

National Institute of Mental Health—Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health—Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

FDA Warning on Codeine Use by Nursing Mothers

The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother's milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showedthat the mother was an ultra-rapid metabolizer of codeine.

"Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research. "And nursing mothers should always consult their physicians before taking any codeine containing products."

Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.

According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.

Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother's breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor's judgment.

Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.

For more information, go to Use of Codeine Products in Nursing Mothers.

FDA Approves Updated Warfarin (Coumadin) Prescribing Information

The U.S. Food and Drug Administration announced today the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain thatpeople's genetic makeup may influence how they respond to the drug.

Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling, FDA said.

The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. Testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug.

These labeling updates are based on an analysis of recent studies that found people respond to the drug differently based, in part, on whether they have variations of certain genes.

FDA estimates that 2 million persons start taking warfarin in the United States every year to prevent blood clots, heart attacks and stroke. Warfarin is a difficult drug to use because the optimal dose varies and depends on many risk factors including a patient's diet, age, and the use of other medications.

Patients who take a dose larger than they can tolerate are at risk of life-threatening bleeding. Those who receive too low a dose are at risk of equally dangerous blood clots. Dosing is particularly important at the beginning of therapy, when problems in adjusting the dose can lead to complications such as bleeding.

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

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.

"Today's approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines Americans depend on," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA's "personalized medicine" initiative makes use of pharmacogenomics—the science that predicts a response to drugs based upon a person's genetic makeup. This effort supports the personalized health program spearheaded by Health and Human Services Secretary Mike Leavitt.

A person's genes "encode" enzymes and differences in the sequence of a gene can cause differences in enzyme activity or sensitivity. That is why different people process the same drug differently.
 
One-third of patients receiving warfarin metabolize it quite differently than expected. Research has shown that some of the unexpected response to warfarin depends on a patient's variants of the genes CYP2C9 and VKORC1.

"Although genetic testing can currently identify who has these genetic variants, more studies are needed to explore the precise starting dose for these patients," said Larry Lesko, Ph.D., director of the FDA's Office of Clinical Pharmacology. "FDA has been working with other government agencies and organizations to develop such studies under the auspices of our three-year-old Critical Path Initiative, which addresses the challenges of moving promising medical products from discovery to patient use."

FDA's Critical Path Initiative has funded a research project with the University of Utah and the Critical Path Institute of Tucson, Ariz., to develop genetically based instructions for warfarin dosing. The Initiative has also facilitated meetings and planning with the National Heart, Lung and Blood Institute for a clinical trial that will study warfarin dosing based on genetic test information and is helping to pay for another clinical study being conducted by Harvard Partners that will derive personalized warfarin dosing algorithms for patients new to the drug.

The dosage and administration of warfarin must be individualized for each patient according to the particular patient's PT/INR response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

Bristol-Myers Squibb Co. of Princeton, N.J., is the manufacturer of Coumadin.

For more information see New Labeling Information for Warfarin.

Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugsmay cause or worsen heart failure in certain patients.

After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and Takeda, to address these concerns.

"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."

FDA's review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.

The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

FDA's review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).

For more information, visit:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
Pioglitazone HCl (marketed as Actos and Duetact) Information

Federal Court Issues Permanent Injunction Against Puerto Rico Dairies for Drug Residues Found in Cows

The United States District Court for the District of Puerto Rico issued an Order of Permanent Injunction against J.M. Dairy Inc. and Las Martas Inc., and Juan Manuel Barreto Ginorio, the owner of the dairies, after illegal drugresidues were found in cows.

The U.S. Food and Drug Administration is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans. The order also prohibits the sale of milk until compliance is met.

The court order follows a civil complaint filed against the defendants on Sept. 19, 2006, based upon FDA's investigations into the dairies and their practices. The dairies produce milk for human consumption and sell dairy cows for slaughter for human consumption.

The injunction is based, in part, on five illegal residues in the edible tissue of three dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between August 2003 and September 2005. The drug residues found by FSIS included antibiotics such as sulfamethazine, sulfathiazole, sulfadimethoxine, and penicillin at levels not permitted by FDA. More recent FDA inspections confirmed that the dairies continued to use animal drugs in a manner contrary to the label directions, without the benefit of a veterinarian's oversight, and failed to maintain record-keeping systems to ensure that they did not sell milk or animals for slaughter for human food with illegal new drug residues.

Under the terms of the Aug. 8, 2007 order, the defendants must implement record-keeping systems to ensure that their use of drugs conforms to FDA regulations and that no milk or animals for slaughter for human food enters into interstate commerce with illegal new drug residues.

The defendants may only resume selling or delivering food—milk or animals for slaughter for human food—in interstate commerce after they are notified by FDA that they are in compliance with the terms of the order.

Consumers Warned to Avoid Eating Raw Oysters from Southern Tip of Hood Canal in Washington State

The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of the southern tip of Hood Canal in Washington after an outbreak of illness caused by Vibrio parahaemolyticus bacteria. 

Symptoms of the illness, called vibriosis, include watery diarrhea, often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in people with weakened immune systems. Those who believe they have experienced these symptoms after consuming raw oysters should consult their health care provider and contact their local health department.

Raw oysters harvested from “growing area 6” in Hood Canal from July 3, 2007 and after, have caused at least six people to become ill in California and Washington. Additional reports of illness are being investigated by the states. To date, records indicate that raw oysters from the area were distributed to California, Florida, Hawaii, Idaho, New York, Oregon, Washington, British Columbia (Canada), Hong Kong, Malaysia, and Singapore.

The Washington State Department of Health has closed the growing area associated with the illness and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them. Consumers who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing area. 

Those with weakened immune systems, including people affected by AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease should avoid eating raw oysters, regardless of where they are harvested.

FDA advises that consumers can continue to enjoy oysters in many cooked preparations by doing the following:

At Restaurants and other Foodservice Establishments:

In the Shell:

To steam—add oysters to water that is already steaming and cook live oysters until the shells open, once open steam for another four to nine minutes.

Shucked Oysters:

For more information: Shellfish growing areas close due to vibriosis outbreak
www.doh.wa.gov/Publicat/2007_news/07-131.htm

FDA Takes Action Against Iowa Dairy for Illegal Drug Residues Found in Cows

A Complaint and Consent Decree of Permanent Injunction were filed Wednesday, August 8 in the U.S. District Court for the Northern District of Iowa, Western Division, against Ysselstein Dairy Inc., Rock Valley, Iowa, and its owner and president, Sjerp W. Ysselstein, after illegal drug residues were found in the dairy's cows. The permanent injunction will not become effective against Ysselstein Dairy until the Court signs and enters the Consent Decree. The action follows FDA investigations into the dairy and itspractices.

The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. The FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans.

Ysselstein Dairy produces milk for human consumption and sells dairy cows for slaughter for human consumption. The injunction is based on nine illegal residues in the edible tissue of seven dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between July 21, 1992, and March 10, 2006. The drug residues found by FSIS included antibiotics such as tetracycline, sulfadimethoxine, flunixin, oxytetracycline, and penicillin at levels not permitted by the FDA.

Under the terms of the Consent Decree, the dairy and Ysselstein must implement systems for identifying animals, keeping records, drug control, drug accountability, and drug residue withdrawal control. Furthermore, if the FDA informs the defendants of their not being in compliance with the terms of the Decree or the Federal Food, Drug, and Cosmetic Act, the FDA may require them to cease operations until they are in compliance. The Decree also provides for the dairy and Ysselstein to pay a fine for each day they fail to comply with the Decree and for each animal that they sell or deliver for sale in violation of the Decree.

FDA's Kansas City District Office conducted the investigations that led to the Consent Decree. FDA's Center for Veterinary Medicine Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Attorney's Office in the Northern District of Iowa processed and filed the case.

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA’s Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

Report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program:
www.fda.gov/medwatch/report.htm; 800-332-1088; Fax: 800-332-0178; and MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

FDA Approves Novel Antiretroviral Drug

The U.S. Food and Drug Administration (FDA) today approved maraviroc, an antiretroviral drug for use in adult HIV patients. Maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancementof HIV and received priority review by the FDA.

Maraviroc is approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load). Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor. CCR5 is a protein on the surface of some types of immune cells. Among patients who have previously received HIV medications, approximately 50 percent to 60 percent have circulating CCR5-tropic HIV-1. "This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the Warnings/Precautions section about the possibility of heart attacks. The FDA's approval of maraviroc is based on safety and effectiveness data from two double-blind, placebo-controlled studies. The 1,076 clinical trial participants were selected because they still showed evidence of HIV-1 in their blood, despite treatment with other HIV medications. A blood test for CCR5 tropic HIV-1 was used during clinical trials to identify patients appropriate for treatment with maraviroc.

The safety and effectiveness of maraviroc have not been established in adult and pediatric patients who have never been treated with any other HIV drug. Additionally, the drug has not been tested or studied in pregnant women. The FDA recommends that HIV positive women should not breast feed, whether or not they are on antiretroviral medications.

The most common adverse events reported with maraviroc were cough, fever, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.

Maraviroc is distributed by New York-based Pfizer Inc.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today approved the first generic versions of Coreg (carvedilol).  Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

"The agency's Office of Generic Drugs ensures that generic drugs are safe and effective through a rigorous scientific and regulatory process," said Gary J. Buehler, director, FDA's Office of Generic Drugs. "Generic drugs, which use the same active ingredients as brand-name drugs and work the same way, offer alternatives to Americans in choosing their prescription drugs."

Carvedilol tablets in four strengths (3.125 milligrams, 6.25 milligrams, 12.5 milligrams and 25 milligrams) are manufactured by multiple generic drug companies. The following company’s applications were approved today: Actavis Elizabeth LLC; Apotex Inc.; Aurobindo Pharma Limited; Caraco Pharmaceutical Laboratories Limited; Dr. Reddy’s Laboratories; Glenmark Pharmaceuticals Limited; Lupin Limited; Mylan Pharmaceuticals Inc.; Ranbaxy Laboratories Ltd.; Sandoz Inc.; Taro Pharmaceutical Industries Ltd.; TEVA Pharmaceuticals USA; Watson Laboratories Inc.; and Zydus Pharmaceuticals USA Inc.

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

According to the publication Drug Topics, Coreg was the 30th top selling brand name drug by retail dollars in 2006.

For information:

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.

FDA Approves Second-Generation Smallpox Vaccine

The U.S. Food and Drug Administration has licensed a new vaccine to protect against smallpox, a highly contagious disease with the potential to be usedas a deadly bioterror weapon.

The vaccine, ACAM2000, is intended for the inoculation of people at high risk of exposure to smallpox and could be used to protect individuals and populations during a bioterrorist attack. It will be included in the Center for Disease Control and Prevention's (CDC) Strategic National Stockpile of medical supplies.

A worldwide vaccination program eradicated smallpox in the population. The last case of naturally occurring smallpox in the U.S. was in 1949 and the last case in the world was reported in Somalia in 1977. Known stockpiles of the virus are kept only in two approved labs in the United States and Russia. The CDC considers it a Category A agent, meaning it presents one of the greatest potential threats for harming public health.

Smallpox is caused by the variola virus, a virus that emerged in human populations thousands of years ago. It spreads through close contact with infected individuals or contaminated objects, such as bedding or clothing. There is no FDA-approved treatment for smallpox and the only prevention is vaccination.

"The licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "This vaccine is manufactured using modern cell culture technology allowing rapid and large scale production of a vaccine with consistent product quality."

The symptoms of smallpox typically began with high fever, head and body aches. A rash followed that spread and progressed to raised bumps and pus-filled blisters that crusted, scabbed, and fell off after about three weeks, leaving a pitted scar. The fatality rate historically was about 30 percent, according to the CDC.

ACAM2000 is made using a pox virus called vaccinia, which is related to but different from the virus that causes smallpox. The vaccine contains live vaccinia virus and works by causing a mild infection that stimulates an immune response that effectively protects against smallpox without actually causing the disease.

The vaccine is derived from the only other smallpox vaccine licensed by FDA, Dryvax, approved in 1931 and now in limited supply because it is no longer manufactured.

Although smallpox vaccination ended in the United States in 1972 because it was no longer needed for prevention, the U.S. military resumed vaccination of at-risk personnel in 1999, after concluding that the disease posed a potential bioterrorism threat.

"Smallpox could be a particularly dangerous biological threat to us that would kill or debilitate a high percentage of the population," said Rear Adm. W. Craig Vanderwagen, M.D., assistant secretary for preparedness and response, U.S. Department of Health and Human Services. "The licensing of ACAM2000 will make us better prepared as a nation because it provides an important, effective tool for protecting first responders and individuals with a high risk of exposure from this potentially lethal disease."

ACAM2000 was studied in two populations: those who had never been vaccinated for smallpox and those who had received smallpox vaccination many years earlier. The percentage of unvaccinated persons who developed a successful immunization reaction was similar to that of Dryvax. ACAM2000 also was found to be acceptable as a booster in those previously vaccinated for smallpox.

Because ACAM2000 contains live vaccinia virus, care must be taken to prevent the virus from spreading from the inoculation site to other parts of the body, and to other individuals.

To minimize known risks, the vaccine licensing is subject to a Risk Minimization Action Plan (RiskMAP). The RiskMAP requires providers of the vaccine and patients to be educated about these and other risks. The RiskMAP also requires patient education through an FDA-approved Medication Guide for those who receive the vaccine.

The Medication Guide explains the proper care of the vaccination site and provides information about serious side effects that can occur with ACAM2000. In studies, about 1 in 175 healthy adults who received smallpox vaccine for the first time developed inflammation and swelling of the heart and/or surrounding tissues (myocarditis and/or pericarditis). Of the 10 affected adults, four had no symptoms and at the end of the study, all but one had their symptoms resolve.

ACAM2000 is manufactured by Acambis Inc. of Cambridge, England and Cambridge, Mass. Dryvax was made by Wyeth Laboratories Inc. based in Madison, N.J.

Food and Drug Administration Press Releases

Background: HHS Secretary Leavitt today delivered to President Bush a strategic framework on import safety. The framework was developed by the Interagency Working Group on Import Safety, established by the President July 18 to examine our nation's system for assuring that all of ourimported products are safe. For more information, visit: http://www.importsafety.gov.

"I strongly endorse the release of the Strategic Framework developed by the Interagency Working Group on Import Safety and commend Secretary Leavitt for leading this comprehensive effort.

Recent recalls of imported products have caused Americans to question the safety of imports. Americans rightly expect to purchase food and medical products without having to worry about their safety; and assuring the safety of these products is a core part of our mission at the FDA. The President has charged the Interagency Working Group to focus their efforts on how to work smarter and better with importers, manufacturers, and other governments to better assure that the imported products we purchase are indeed safe. As part of this Presidential initiative, Secretary Leavitt and I have traveled extensively these past few months throughout the U.S. visiting the Agency's field operations. Across the country, we witnessed our field staff standing shoulder to shoulder with our partners from the U.S. Department of Agriculture and Customs and Border Protection and others, working together to assure the safety of imported products. In visits to nearly 20 cities/ports from Oakland to Miami, including El Paso, Tex.; Newark, N.J.; and Memphis, Tenn, we saw dedicated professionals doing difficult work; observing first hand the diligent efforts of FDA employees and what they do every day to protect the American people. Most importantly, we heard from these professionals many ideas on how they believe we could do this job better and smarter.

The three organizing principles that form the keystones of the Strategic Framework: Prevention, Intervention and Response are ones we embrace strongly here at FDA and are principles we know will guide us towards better and smarter import safety strategies. We know that in the 21st century's global economy, our efforts to assure product safety for Americans cannot just begin at our borders, they must begin at the time the products are produced in other countries. I am excited about the fact that these principles have been embraced by the Framework, and I look forward to working with the Group on the Action Plan to be released in November. Together, we will further integrate and enhance our processes relating to the safety of imports."

Food and Drug Administration Press Releases

Sheldon Bradshaw, Associate General Counsel/Chief Counsel of the Food & Drug Division of the U.S. Department of Health and Human Services' Office of the General Counsel has announced that he will leave the department, effective Sept. 12, 2007 to return to the private sector.

Bradshaw joined HHS as Associate General Counsel for the Food and Drug Division in April 2005. In that position, he provided legal advice to FDA's senior leadership on a number of significant policy matters, including the agency's drug and food safety initiatives.

Bradshaw also formulated the legal basis for numerous regulations and guidances critical to the agency's vital public health mission, including the new drug and biologic products labeling rule, enforced the requirements of the Food, Drug and Cosmetic Act in federal court, and defended the agency's programs when they were challenged.

"Leadership and insight from the Office of the General Counsel's Food and Drug Division is essential to FDA's operations, and the agency is well-served by the talented individuals in this office," said Andrew C. von Eschenbach, M.D., Commissioner, Food and Drugs. "I have greatly appreciated Sheldon's wise legal counsel, steadfast support and tireless dedication, and wish him well as he returns to the private sector."

Jeffrey Senger, the current Deputy Associate General Counsel has become the Acting Associate General Counsel until a permanent replacement is appointed.

Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today licensed 15 new blood typing teststhat were previously unavailable in the United States.

These tests, known as blood grouping reagents, are used to determine the bloodtype of blood donors, an essential step in ensuring safe blood transfusion forpatients. If mismatched blood is administered to a patient, it may cause a seriousand potentially fatal reaction. To prevent such problems, people must receivecompatible blood based on the results of blood typing tests.

The newly approved ALBAclone Blood Grouping Reagents include the common ABO and Rh tests, plus tests for rare blood types. The reagents are monoclonal antibodies, highly specific antibodies that ensure product uniformity andavailability.

"The licensing of these reagents will provide more choice for blood establishments and transfusion services and may facilitate testing for rare blood groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "Licensure of these additional blood grouping reagents will help ensure a more stable supply of these tests, especially important in the event of a product shortage."

The reagents are manufactured by Alba Bioscience, Inc. of Durham, N.C.

FDA Approves New Uses for Evista

The U.S. Food and Drug Administration today approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Evista is only the second drug approved to reduce the risk of breast cancer.

Evista is commonly referred to as a selective estrogen receptor modulator (SERM). In reducing the risk of invasive breast cancer, SERMs may act by blocking estrogen receptors in the breast.

"Today's action provides an important new option for women at heightened risk of breast cancer," said Steven Galson, M.D., M.P.H., director, FDA's Center for Drug Evaluation and Research. "Because Evista can cause serious side effects, the benefits and risks of taking Evista should be carefully evaluated for each individual woman. Women should talk with their health care provider about whether the drug is right for them."

On July 24, 2007, FDA's Oncology Drugs Advisory Committee recommended approval of Evista for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in women at high risk for breast cancer.

In 1997, FDA approved Evista for the prevention of osteoporosis in postmenopausal women and, in 1999, for the treatment of postmenopausal women with osteoporosis.

Breast cancer is the second leading cause of cancer death in American women and accounts for 26 percent of all cancers among women. An estimated 178,480 new cases of invasive breast cancer are expected to occur among women in the United States during 2007. Invasive breast cancer develops when abnormal cells spread into the surrounding breast tissue.

Three clinical trials in 15,234 postmenopausal women comparing Evista to placebo (no drug) demonstrated that Evista reduces the risk of invasive breast cancer by 44 to 71 percent. A fourth clinical trial in 19,747 postmenopausal women at high risk for developing breast cancer compared Evista to tamoxifen. In this trial, the risk of developing invasive breast cancer was similar for the two treatments. The clinical trials were conducted over the last 10 years.

Evista can cause serious side effects including blood clots in the legs and lungs, and death due to stroke. Women with current or prior blood clots in the legs, lungs, or eyes should not take Evista. Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating. Evista should not be taken by premenopausal women and women who are or may become pregnant because it may cause harm to the unborn baby. In addition, Evista should not be taken with cholestyramine (a drug used to lower cholesterol levels) or estrogens.

The benefits and risks of taking Evista should be carefully weighed in each individual woman. Evista does not completely prevent breast cancer. Breast examinations and mammograms should be done before starting Evista and regularly thereafter.

The product is manufactured by Eli Lilly and Company, Indianapolis, Ind.

For more information, visit: http://www.hhs.gov/breastcancer/

Food and Drug Administration Press Releases

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 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.

Food and Drug Administration Press Releases

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)

Food and Drug Administration Press Releases

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).

Food and Drug Administration Press Releases

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)

Food and Drug Administration Press Releases

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

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.



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