Flu Drug Tamiflu OK for Babies Under 1: FDA
FRIDAY Dec. 21, 2012 -- Children as young as two weeks old can now be given the flu medication Tamiflu under an expanded approval announced Friday by the U.S. Food and Drug Administration.
Tamiflu (oseltamivir) can be used as treatment in children aged two weeks to one year if they have had flu symptoms for no longer than two days. The drug is not approved to prevent flu in these children.
The safety and effectiveness of Tamiflu in children younger than two weeks of age has not been established, the FDA noted.
The FDA first approved Tamiflu for adults in 1999. Most recently, it had been approved to treat adults and children aged one year and older who have had flu symptoms for no longer than two days, and to prevent flu in adults and children aged one year and older.
There are fixed dosing regimens for children one year and older according to weight categories, but dosing for children younger than one year must be calculated for each patient based on their exact weight, the FDA stressed.
These children should receive 3 milligrams per kilogram of weight twice daily for five days. The smaller doses in this group of children will require a different dispenser than the one currently 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," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.
"Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight," he added.
Tamiflu is the only product approved in the U.S. to treat flu in children younger than one year. It is not a substitute for early, annual flu vaccination, the FDA said. All people aged six months and older should receive an annual flu vaccine, the U.S. Centers for Disease Control and Prevention recommends.
The U.S. Centers for Disease Control and Prevention has more about children, the flu and the flu vaccine.
Posted: December 2012