Tracleer (bosentan)
Published: Thu Mar 02 00:00:00 -0500 2006
Actelion and FDA notified healthcare professionals of changes to the prescribing information 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.