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.

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

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.

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 on this 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 Not to Consume "Organic Pastures Raw Cream"
Risk of Listeria Contamination
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 "SEP 21."

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).

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)

[ 本帖最后由 shaobei 于 2007-9-27 09:24 编辑 ]

New Law Ensures Access to Medical Treatments and Information
Legislation Reauthorizes Key User Fee Programs
Following the President’s signature of the Food and Drug Administration (FDA) Amendments Act, HHS Secretary Mike Leavitt praised the bill as an important step forward in ensuring the safety of drugs and medical devices.

"Facilitating safe and timely access to effective medicines is a critical mission of the federal government," Secretary Leavitt said. "These laws will greatly benefit the public health of our nation, and keep us on a path to ensuring Americans have access to the best medications and devices available to lead longer and healthier lives."

Commissioner of the Food and Drug Administration Dr. Andrew von Eschenbach said, "The act continues essential and successful programs that will enhance FDA’s ability to more efficiently and effectively regulate drugs, biological products, and medical devices. It will provide enormous benefit to the public health by allowing FDA to continue to deliver safe and effective medical products to Americans every day."

The measure extends the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which have yielded vital information about the use of drugs and biological products to treat children.

In addition, the legislation amends and establishes many other programs and activities related to medical product safety. It also establishes a nonprofit corporation, the Reagan-Udall Foundation, to advance the mission of FDA.

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products
Action to impact approximately 200 cough-suppressant products
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs. The action does not affect other hydrocodone formulations, which have FDA approval.

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

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

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

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

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

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

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

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

Additional Influenza Vaccine Approved for Upcoming Influenza Season
Approval increases available doses to record level
The U.S. Food and Drug Administration today approved Afluria, an additional seasonal influenza vaccine for the immunization of people ages 18 and older.

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

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

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

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

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

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

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

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

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

FDA Approves Lamisil for Pediatric Treatment of Scalp Ringworm
Medication comes in easy to take granules
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.

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[ 本帖最后由 shaobei 于 2007-9-29 10:05 编辑 ]