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U.S. Department of Health and Human Services

Safety

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Tracleer (bosentan)

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]