Tamiflu Approved to Prevent Flu in Kids Under 12
But it's not a substitute for a flu shot, FDA says
FRIDAY, Dec. 23, 2005 (HealthDay News) -- The Roche Pharmaceuticals drug Tamiflu (oseltamivir phosphate) has been approved by the U.S. Food and Drug Administration to prevent flu in children 1 to 12 years of age. While it's the first drug approved to prevent both the A and B types of flu in children, Tamiflu is not a substitute for the annual flu vaccine, the FDA warned.
In a study of 222 children, the drug reduced the incidence of flu from 17 percent among those who received no preventive treatment to 3 percent in the group that received Tamiflu. The benefit in children mirrored results from previous trials involving adults, the FDA said.
Common side effects included nausea, vomiting, headache, and fatigue. Vomiting was reported more often among children who received a twice-daily dose of the drug than among those given Tamiflu once a day.
The FDA warned that people should stop taking Tamiflu if they develop a severe skin rash or allergic symptoms. The agency said it asked Roche to conduct additional studies of the drug's long-term safety.
The oral anti-viral drug was first approved in 1999 to treat and prevent influenza in adults. It was subsequently sanctioned to treat the illness in children older than 1 year.
Check this FDA site to learn more about Tamiflu.