Labelling changes for Tracleer following liver failure case

An FDA safety information alert has led to a change in the prescribing information for Tracleer (bosentan), Actelion's market-leading PAH treatement.

A letter from Actelion to health professionals states that the labelling changes are based on "rare cases of hepatoxicity [liver damage]", including that of a female patient with "multiple co-morbidities and on multiple drug therapies" who, after 21-months of treatment with Tracleer, experienced "marked elevations in aminotransferase and bilirubin levels".

The patient then discontinued her Tracleer treatment, but continued to experience elevated aminotransferase and rising bilirubin levels before being hospitalised for an iv catheter infection and going on to develop liver failure and cirrhosis.

"A contribution of Tracleer to the development of liver failure could not be ruled out," states the letter. The patient's liver failure abated around seven months after she discontinued Tracleer.

Actelion has used the case to "underscore the need to continue monthly [liver function] monitoring for the duration of Tracleer treatment [and] adhere to the recommended dosage adjustment and monitoring guidelines".