Actelion Updates Tracleer Labeling

The Food and Drug Administration (FDA) released the following information:

Actelion and the FDA notified healthcare professionals of changes to the prescribing information of Tracleer (Bosentan) based on cases of hepatotoxity reported. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.