FDA MedWatch – Tracleer (bosentan):
Recommended Dosage Adjustment and Monitoring Guidelines
to Avoid Hepatotoxicity
Actelion and FDA notified healthcare professionals
of changes to the Tracleer (bosentan) prescribing information
based on cases of hepatotoxity reported. Tracleer is
indicated for the treatment of pulmonary arterial hypertension.
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.
Read the complete MedWatch 2006 Safety summary, including
links to the Dear Healthcare Professional letter, revised
prescribing information and medication guide at:
www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer |
