Tamiflu Use Expanded to Treat Children Younger Than One Year

Drug Alerts , News / October 2, 2016

The FDA has expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.

Tamiflu, however, has not been approved to treat flu infection in this population. Also, the safety and efficacy of Tamiflu to treat flu infection in children younger than 2 weeks old has not been established.

Tamiflu was originally approved in 1999 to treat adults infected with the flu who have shown symptoms for no longer than two days. Since then it has been approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than two days, and to prevent flu in adults and children ages 1 year and older.

Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 mg/kg twice daily for five days. These smaller doses require a different dispenser than what is currently co-packaged with Tamiflu.

Tamiflu is the only product approved to treat the flu infection in children younger than 1 year old, providing an important treatment option for a vulnerable population. According to the Centers for Disease Control and Prevention (CDC), children younger than 2 years are at higher risk for developing complications from the flu, with the highest rates of hospitalization in those less than 6 months of age.

Tamiflu is not a substitute for early, annual flu vaccination, as recommended by the CDC’s Advisory Committee on Immunization Practices. CDC recommends all persons aged 6 months and older receive an annual flu vaccine.

Tamiflu is distributed in the United States by South San Francisco-based Genentech, a member of the Roche Group.

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