Pediatric Information Added to Label of Hepatitis B Antiviral Entecavir

This article was reported by Family Practice News.

Family Practice News reported that the US Food and Drug Administration announced that changes to the prescribing information for the chronic hepatitis B drug entecavir have been added for children down to 2 years of age. Previously, the drug's label stated that the safety and effectiveness of entecavir in pediatric patients younger than 16 had not been established. The label now states that the efficacy and safety have not been established in patients younger than 2, and that no drug studies for this age group have been conducted because of the rare need for treatment. A revised label statement indicates that entecavir is for treating chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older, who have evidence of active viral replication and either evidence of persistent elevations of serum aminotransferases or histologically active disease. Approved in 2005, entecavir is a nucleoside analogue marketed as Baraclude by Bristol-Myers Squibb.