Anti-influenza drug's age indication expanded—downward—by FDA

January 13, 2006

The US Food and Drug Administration in December approved the use of Tamiflu (oseltamivir phosphate) for preventing seasonal influenza in children 1 to 12 years old. Tamiflu's labeled use had previously been for prevention and treatment of flu in children 13 years and older, as well as in adults.

The US Food and Drug Administration in December approved the use of Tamiflu (oseltamivir phosphate) for preventing seasonal influenza in children 1 to 12 years old.

Tamiflu's labeled use had previously been for prevention and treatment of flu in children 13 years and older, as well as in adults.

The most common side effects of oseltamivir are nausea, vomiting, headache, and fatigue. The FDA has requested additional postmarketing study data from Roche Pharmaceuticals, the drug's manufacturer, to support the long-term safety of the drug.

Tamiflu is not a substitute for annual influenza vaccination in children or adults, who should continue to be vaccinated according to recommendations or at their option.