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FDA MedWatch - Tracleer (Bosentan): Recommended Dosage Adjustment and Monitoring Guidelines to Avoid Hepatotoxicity
BETHESDA, M.D. -- March 2, 2006 -- 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:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer
SOURCE: FDA Safety Information and Adverse Event Reporting Program
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