FDA approves Tamiflu in children younger than one year

The U.S. Food and Drug Administration recently announced the expansion of the approved use of Tamiflu to treat children under the age of one and as young as two weeks old.

The drug, also known as oseltamivir, can be used to treat children who show symptoms of flu for no longer than two days. Tamiflu is not approved for the prevention of influenza or for children under the age of two weeks old.

Tamiflu is the only product with FDA approval to treat flu infection in children under one year of age. Children under the age of two are at higher risk for flu complications, according to the Centers for Disease Control and Prevention. Children under the age of six months have the highest rate of flu-related hospitalization.

The FDA extrapolated data from previous study results in older children and adults along with supporting safety and pharmacokinetic studies to expand the approved use of Tamiflu. Pediatric legislation allows for efficacy to be extrapolated from study results if the illness being studied and effects of the drugs are sufficiently similar in pediatric patients and adults.

Tamiflu is not a substitute for early and annual flu vaccination. The CDC recommends that all people aged six months and older receive an annual flu vaccination.

The FDA is an agency within the U.S. Department of Health and Human Services that monitors drugs for side effects.