The FDA expanded the approved use of Tamiflu this week to include children as young as two weeks old who show symptoms of flu for no longer than two days.
The safety and efficacy of Tamiflu in children younger than two weeks of age, however, has not be established.
Tamiflu was first approved in 1999 as a means of treating adults infected with the flu who showed symptoms for no longer than two days. Since then, it has been approved to treat flu in children one year of age and older with symptoms of the flu for no longer than two days and to prevent flu in those over the age of one.
Dosing for children one year of age or younger must be calculated for each patient based on exact weight, with three milligrams of Tamiflu per kilogram administered twice daily for five days. The lower 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," Edward Cox, the director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."