- Copyright © 2012, The American Academy of Pediatrics
The U.S. Food and Drug Administration (FDA) on Friday expanded the approved use of Tamiflu (oseltamivir) to treat young children. Tamiflu now can be used to treat children as young as 2 weeks old who have exhibited symptoms of flu for two days or less, the FDA announced.
The drug is not approved treat children younger than 2 weeks old. When providing Tamiflu to children younger than 12 months of age, parents and health care professionals must calculate dosage based on each patient’s exact weight. These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu.
Tamiflu was approved in 1999 to treat adults infected with flu and later was approved for children 12 months of age and older.
“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 expanded the approved use of Tamiflu in younger children based on the 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.
Studies showed the safety profile in children younger than 1 year of age was consistent with the established safety profile of adults and older children. The most common side effects reported with Tamiflu use in this age group include vomiting and diarrhea.
Tamiflu is the only product approved to treat flu infection in children younger than 1 year of age. Children younger than 2 years old 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 Centers for Disease Control and Prevention (CDC).
Tamiflu is not a substitute for early, annual flu vaccination as recommended by the AAP and CDC’s Advisory Committee on Immunization Practices. The AAP and CDC recommend all persons aged 6 months and older receive an annual flu vaccine.
Tamiflu is distributed in the United States by South San Francisco-based Genentech, a member of the Roche Group.
For more information, visit http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm.