Drug maker issues new label warnings for Tasmar
Drug maker issues new label warnings for Tasmar
Increased post-marketing instances of severe and fatal liver failure in patients being prescribed Hoffman-LaRoche’s Tasmar (tolcapone), a COMT inhibitor adjunct to levodopa and carbidopa for Parkinson’s disease symptoms, have led to new warning labels by the drug maker. As of October 1998, three patients had died of acute fulminant liver failure, while increased cases of severe hepatocellular injury have been reported.
New boxed warning labels stress that the drug should be used as an adjunct treatment only, and a patient consent section urges education. The new warning, among other points, notes that patients failing to show clinical benefit from the drug within three weeks should be taken off Tasmar.
For more details, contact Russell Ellison, MD, Vice President for Medical Affairs, Roche Laboratories, 340 Kingsland St., Nutley, NJ 07110.
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