FDA Approves Tamiflu for Infants

Dec. 21, 2012 -- Children as young as 2 weeks old may now be treated for the flu with Tamiflu.

The FDA expanded its approval today for Tamiflu to include infants under age 1 who have had symptoms of the flu, such as stuffy nose, cough, sore throat, fever, and body aches, for no longer than two days.

It is not approved to prevent flu infection in this age group.

Tamiflu is now the only drug approved to treat the flu in children under age 1, who are at higher risk of developing complications of the flu.

Until now, Tamiflu was approved to treat the flu in adults and children ages 1 year and older who have had symptoms for less than two days. The drug is also approved to prevent flu infection in children and adults over 1 year of age.

FDA officials say there is a fixed dosing schedule for children and adults over age 1, but dosing for children under 1 year old must be calculated for each infant according to their weight.

Children under age 1 should receive 3 milligrams of Tamiflu per kilogram of body weight twice daily for five days. This smaller dose requires a different dispenser than what currently comes in the Tamiflu package.

“Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.”

According to the CDC, children younger than 2 years old are especially vulnerable to developing complications from the flu. Infants 6 months of age and younger have the highest rates of hospitalization for the flu.

The FDA based its approval of Tamiflu for children under age 1 on data from previous studies in adults and older children.

Two new safety studies in 135 children under 1 year old with confirmed cases of the flu also showed the safety profile in infants was consistent with that found among older children and adults.

The most common side effect in these studies was vomiting and diarrhea.

Rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported with use of Tamiflu but were not found in these new safety studies.

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