The decision makes Tamiflu the first drug approved to prevent both influenza A and influenza B in pediatric patients.
However, "Tamiflu is not a substitute for the flu vaccine," the FDA says in a news release.
"Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices," the news release continues.
About Tamiflu and Flu
Tamiflu, taken by mouth, targets the virus that causes flu. Tamiflu already has FDA approval to prevent and treat influenza in teenagers and adults.
Tamiflu also is approved to treat influenza in children who are more than 1 year old.
The flu is not the same as a common cold. The flu can be severe and even fatal; the young, old, and those with chronic medical conditions are at greatest risk.
Flu season is already under way. It can begin as early as October and end as late as May, states the CDC. The CDC recommends these steps to prevent the flu's spread:
Kids have been shown to be less likely to catch the flu from a household member if they take Tamiflu for flu prevention, says the FDA.
The FDA cites a study of more than 1,100 people including 222 children aged 1 to 12 years. Participants living with someone diagnosed with seasonal flu were split into two groups. One group took Tamiflu once daily for 10 days. The others only got Tamiflu if they became ill.
Fewer children taking Tamiflu developed the flu (3%, compared to 17% of those not taking Tamiflu for flu prevention).Tamiflu has shown similar flu-prevention benefits in older people, says the FDA. However, Tamiflu hasn't been shown to prevent flu in people with compromised immune systems, the FDA adds.
The FDA says that in studies, Tamiflu's side effects were similar when the drug was taken to treat or prevent the flu. The most common side effects were nausea, vomiting, headache, and fatigue.
Vomiting was reported more often in people taking Tamiflu twice daily to treat flu than in those taking the drug once daily. In one study, vomiting was more common among children than adults, probably due to the dose used, the FDA says.
Although no new side effects occurred in these studies, the FDA has asked Tamiflu's maker, Roche Pharmaceuticals, to provide additional post-marketing study data to support the drug's long-term safety.
The FDA says a comprehensive review of Tamiflu's post-marketing safety reports indicated rare reports of severe rashes and allergic skin reactions that may be drug-related.
As reported in November 2005, the FDA has ordered Tamiflu's label to carry warnings about serious skin/hypersensitivity reactions.
Patients should stop taking Tamiflu and contact their doctors if they develop a severe rash or allergic symptoms, the FDA says.
SOURCES: News release, FDA. CDC: "Key Facts about Influenza and the Influenza Vaccine." CDC: "Preventing the Flu." WebMD Medical News: "FDA: Tamiflu Safe for Kids."
By Miranda Hitti
Reviewed by Louise Chang, MD
© 2005, WebMD Inc. All rights reserved