FDA and Actelion Pharmaceuticals ‘Reminder’ of Hepatotoxicity

Tracleer May Cause Hepatotoxity. In a MedWatch Alert, the FDA has notified cardiopulmonary healthcare professionals of the following: “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.” (http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer)

In a more detailed letter to healthcare professionals, Actelion Pharmaceuticals US, Inc. (http://www.fda.gov/medwatch/safety/2006/tracleer_dhcp_final.pdf) has emphasized the extreme importance of “monthly liver function tests (LFT) and, if a woman of childbearing potential, to have a pregnancy test done, prior to the monthly refill shipment of Tracleer.”

This “reminder” from the FDA and the manufacturer was prompted by changes in the prescribing information (http://www.fda.gov/medwatch/safety/2006/TracleerPI_012006.pdf) for the drug that were based on postmarketing reports of hepatotoxicity in Tracleer (bosentan) patients.

Since one of the reports involved a woman who suffered liver failure in which bosentan-involvement could not be ruled out, the FDA believed the emphasis on monthly LFT and adjustments in dosage recommendations were required.

Product Labeling

In this regard, Actelion’s letter states: “This case underscores the need to continue monthly monitoring for the duration of Tracleer treatment. It also emphasizes the need to adhere to the recommended dosage adjustment and monitoring guidelines described below and in the product labeling.” (The letter then sets forth “Dosage Adjustment and Monitoring in Patients Developing Amniotransferase Abnormalities”)

Tracleer (bosentan) is indicated for the treatment of moderate to severe pulmonary arterial hypertension (P.A.H.) and is only available through a risk-management program (Tracleer Access Program), which requires monthly assessments of liver function in all patients and negative pregnancy test results in women of childbearing age.

Actelion “strongly encourages” healthcare professionals “to submit a report of any serious adverse events that occur with the use of Tracleer to 1-888-835-5445, or to the FDA’s MedWatch Adverse Event Reporting program online , by phone , or by returning the postage-paid FDA form 3500 by mail or fax .”

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