Tracleer FDA Alerts
The FDA Alert(s) below may be specifically about Tracleer or relate to a group or class of drugs which include Tracleer (bosentan).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for bosentan
Mar 2, 2006
Audience: Cardiopulmonary healthcare professionals[Posted 03/02/2006] 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.
[March 01, 2006 – Letter – Actelion]