Tamiflu available for kids 2 weeks and older

December 26, 2012

Oseltamivir (Tamiflu) can now be used to treat children who are 2 weeks of age and older, according to an FDA press release.

Oseltamivir (Tamiflu) can now be used to treat children who are 2 weeks of age and older, according to an FDA press release.

The drug is used to treat children who have shown flu symptoms for two days or less.

"The drug is not approved to prevent flu infection in this population," the release stated. "In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old."

Approved in 1999, Tamiflu treats adults who have the flu and have shown symptoms for no longer than two days. It was later approved to treat children age 1 and older and to prevent flu in adults and children 1 year and older. The dosing for children younger than 1 year old must be calculated based on each patient's weight.

"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, MD, MPH, 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."

No other products other than Tamiflu have been approved to treat flu in children younger than one year.

"The FDA expanded the approved use of Tamiflu in children younger than 1 year based on extrapolation of data from previous study results in adults and older children, and additional supporting safety and pharmacokinetic studies sponsored by both the National Institutes of Health and Roche Group, Tamiflu's manufacturer," the release stated.

Nearly all of the 135 children enrolled in the two safety studies had confirmed cases of flu.

"According to the Centers for Disease Control and Prevention (CDC), children younger than 2 years are at higher risk for developing complications from the flu, with the highest rates of hospitalization in those less than 6 months of age," according to the release.

 

------------------------------------------------------------

Check out our Facebook and Twitter pages!