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Published On: Fri, Dec 21st, 2012

Tamiflu approved to treat children as young as 2 weeks old: FDA

Public domain image/Moriori at the English Wikipedia project (cropped)

Public domain image/Moriori at the English Wikipedia project (cropped)

The U.S. Food and Drug Administration (FDA) today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days, according to an FDA news release today.

The federal regulatory agency clearly states that the flu drug is not approved to prevent flu infection in this population.

In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old.

According to the release, dosing for Tamiflu in this population has to be calculated:

Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 milligrams per kilogram twice daily for five days. These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu.

“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.”

“We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the CDC advises against vaccinating infants less than six months of age,” said Hal Barron, M.D., chief medical officer and head, Global Product Development for Genentech.

Tamiflu was first approved in the United States over 13 years ago. Approximately 30 million children worldwide over the age of one, including an estimated 6.9 million children in the United States, have received a prescription for Tamiflu.

Tamiflu (oseltamivir) is an antiviral medication that blocks the actions of influenza virus types A and B in your body.

Tamiflu is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Tamiflu may also be given to prevent influenza in people who may be exposed but do not yet have symptoms. It will not treat the common cold.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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