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FDA Approves Tamiflu for Flu Prevention in Kids Under 12

First drug approved for the prevention of both influenza A and B in pediatric patients

THURSDAY, Dec. 29 (HealthDay News) -- The U.S. Food and Drug Administration approved the use of Tamiflu (oseltamivir phosphate) for the prevention of influenza A and B in children between the ages of 1 and 12 years, who have been exposed to the flu. Tamiflu is already approved for the prevention and treatment of influenza in adolescents aged 13 and older and in adults, and for treatment in pediatric patients older than age 1.

Approval was based on studies of households containing a total of 1,100 individuals, including 222 children between 1 and 12 years of age. When an index case of influenza was diagnosed, members of the household were given Tamiflu prophylactically once a day for 10 days or received no drug unless they became ill.

Three percent of children treated with Tamiflu developed flu symptoms compared with 17% of children with no treatment. These are rates similar to those seen in adults.

The most common adverse effects were nausea, vomiting, headache and fatigue. Vomiting occurred in more patients receiving Tamiflu for treatment than for prevention and was more common in children than in adults. No new adverse effects occurred in the children in this study, but the FDA is requesting post-marketing surveillance data.

FDA officials stress that Tamiflu is not a substitute for immunization.

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