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Tamiflu Approved By FDA for Use in Infants Over 2 Weeks Old

Update Date: Dec 24, 2012 12:49 PM EST

Tamiflu (Oseltamivir) has been approved for children as young as two weeks with flu symptoms, the U.S. Food and Drug Administration (FDA) has announced Friday in a statement. Tamiflu was previously only approved for patients aged one year or more.

The FDA stressed that the drug is not approved as a preventive measure against flu in children that young. It is also not approved to treat flu in children younger than 2 weeks old.

Tamiflu was first approved in 1999 and is distributed in the United States by Genentech, part of Roche. It was co-developed by Gilead Sciences. Its most common side effects include vomiting and diarrhea. It was then approved for children aged 1 year or older who also had flu symptoms for no more than 48 hours. It was also approved for preventing flu in both adults and children aged at least 12 months.

Infants from 2 weeks to 12 months should be given 3 milligrams per kilogram of bodyweight twice daily for five days. For these smaller doses, a different dispenser from the current one that is co-packaged with Tamiflu will be required.

"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."

The FDA stressed that Tamiflu is not a substitute for early, annual flu vaccination, as recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices. The CDC recommends all persons aged 6 months and older receive an annual flu vaccine.

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