(By Balaseshan) The U.S. Food and Drug Administration (FDA) has expanded the use of Tamiflu (oseltamivir), which is distributed by South San Francisco-based Genentech, a member of the Roche Group, to treat children younger than one year.
FDA 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.
The expanded use is based on extrapolation of data from previous study results in adults and older children, and additional supporting safety and pharmacokinetic studies sponsored by both the National Institutes of Health and Roche Group, Tamiflu's maker.
The drug is not approved to prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old.
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In 1999, Tamiflu was approved to treat adults infected with flu who have shown symptoms for no longer than two days. It has since 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 one year and older according to weight categories, the dosing for children younger than one year must be calculated for each patient based on their exact weight. The children should receive 3 milligrams per kilogram twice daily for five days.
Almost all of the 135 pediatric patients enrolled in the two safety studies had confirmed flu. Results from these studies showed the safety profile in children younger than 1 year was consistent with the established safety profile of adults and older children.
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The most common side effects reported with Tamiflu use in this age group include vomiting and diarrhea. Although not seen in the new studies, rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported.