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article imageFDA expands use of Tamiflu for babies as young as 2 weeks old

By Leigh Goessl     Dec 23, 2012 in Health
The U.S. Food and Drug Administration has approved the expanded use of Tamiflu to allow children as young as 2 weeks old to take the drug.
On Friday, the U.S. Food and Drug Administration (FDA) issued a press release that announced the expanded use of Tamiflu (oseltamivir), a medication that has been on the market to treat adults since 1999. The drug was later approved to include children ages 1 year of age and older, and as of this week's announcement, babies 2 weeks old up to 1 year can also receive the medication.
The drug is not approved to prevent flu infection for infants, but can be administered to children that have shown symptoms of flu for no longer than two days.
There is no fixed amount of dosing for children under the age of one.
“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.”
Experts say Tamiflu is not a replacement for the flu vaccine. Additionally, the FDA says the safety and effectiveness of the drug in babies 2 weeks old and younger has not been established.
According to Reuters, common side effects of Tamiflu are vomiting and diarrhea.
Additionally, there are some that suggest there is little evidence that Tamiflu works, according to the Reuters report. The drug saw a spike in sales in 2009 when the H1N1 swine flu epidemic made headlines.
Recently, Roche, the company that makes the anti-viral drug, was criticized by British Medical Journal that the company hid data on Tamiflu's ability to treat the flu.
The U.S. Centers for Disease Control and Prevention (CDC) offers additional information on flu medications and vaccines. The agency recommends an annual flu shot for all individuals ages 6 months and older.
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