FDA: Tamiflu Safe for Kids

From:Internet   Author:Admin   Time:2007-04-19   Font: [big center small]  

Nov. 18, 2005 - An FDA committee has reportedly called the flu drug Tamiflu safe for children.

The Associated Press reports that the FDA's Pediatric Advisory Committee found no clear sign that Tamiflu was involved in the deaths of 12 children in Japan who had taken the drug.

The committee reportedly recommended that Tamiflu's label note the possibility of skin reactions to the drug. The committee also asked for a full report in two years on any adverse events associated with Tamiflu, with an interim report next year.

With flu season under way, the FDA notes that flu can be a serious and even fatal illness -- especially for the young, old, and ill -- and that the most effective way to prevent flu is to get an annual flu vaccine.

Most Reports From Japan

The reported problems include the deaths of 12 children taking Tamiflu in Japan. Those reports were made from March 22, 2004, through April 22, 2005.

The FDA isn't blaming Tamiflu for any of those deaths. "Based on the information available to us, we cannot conclude that there is a causal relationship between Tamiflu and the reported pediatric deaths," says the FDA.

Other reports include 32 cases of neurological and psychiatric problems and 12 cases of allergy-like skin reactions.

All of the deaths and almost all of the other reported cases came from Japan, according to the FDA. The neurological and psychiatric problems may have stemmed from flu complications, but FDA papers don't pinpoint the exact cause of those issues.

Here are some Tamiflu questions and answers from the FDA:

What should I do about this information?

If you or your child is receiving Tamflu for the treatment of the flu and you are concerned that you may be experiencing a drug-related adverse event, you should contact your doctor for advice and management.

Adverse events should be reported to the FDA's MedWatch system. Contact MedWatch online at www.fda.gov/medwatch or by phone at (800) FDA-1088 ((800) 332-1088).

Keep in mind that the most effective way to prevent influenza and its complications is by getting the annual flu vaccine.

Children younger than 9 receiving their first flu vaccine should receive a second dose given at least one month later.

Children from 6 months to 2 years of age and those with certain underlying medical conditions are considered at high risk for developing complications of influenza and are strongly encouraged to get the vaccine.

What is useful about Tamiflu in pediatric patients? Who should use it?

When used as directed (twice daily for five days), Tamiflu can shorten flu symptoms in otherwise healthy children by a day or a day and a half. It also appears to reduce the severity of common flu symptoms. Consequently, Tamiflu may allow children to return to school or other normal activities sooner.

Tamiflu was also shown to be similarly effective in children who had a history of asthma and did not worsen the asthma symptoms.

Tamiflu is most effective when taken within 48 hours after the beginning of flu symptoms and is not likely to be effective if patients have already had flu symptoms for several days.

Patients (and their parents) should be aware that some patients with influenza may be at risk for secondary bacterial infections and should seek medical care if they are not improving within a few days of beginning Tamiflu.

Tamiflu has not been studied in children with very severe or complicated influenza who require hospitalization, and it is not known whether it will provide the same benefit to children with severe illness.

Tamiflu's Maker Responds

In a news release, Roche, which makes Tamiflu, says it will work closely with the FDA to continue to monitor the use of Tamiflu in children.

"The risk-benefit ratio for Tamiflu remains unchanged and positive, supporting the use of the medication for the treatment of children greater than one year of age with influenza infection," says Roche.

Tamiflu has been used by about 33 million people worldwide, include nearly 12 million children in Japan, according to Roche.

The reported deaths in Japan work out to one in a million treated patients, which is in accord with or lower than published death rates for children with flu, says Roche.

Roche says Tamiflu is "generally well tolerated," with nausea and vomiting as the most common side effects.

Previous: FDA OKs 1st Generic Version of Zocor   Next: FDA Warns of Drug-Suicide Risk in Kids