ACTELION CHANGES LABELING FOR TRACLEER

Actelion has announced changes to labeling for its anti-hypertension drug Tracleer because of risks of liver damage.

The company has included data on dosage adjustments and monitoring requirements for Tracleer (bosentan) based on a patient's liver enzyme levels, Actelion said in a March 1 letter to healthcare professionals. As enzyme levels increase, a variety of different strategies including reducing dosage and stopping treatment are recommended, the company said.

Actelion said that potential threats of liver damage from the drug highlight the need for monthly monitoring of liver enzyme levels "for the duration of Tracleer treatment," the company's letter says.

For more information, access http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer (http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer).