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1/17/1999

New Warnings for Parkinson's Drug, Tasmar

Cheryl A. Thompson

FDA and Hoffman-La Roche Inc., the manufacturer of the drug tolcapone (Tasmar) for patients with Parkinson’s Disease, are advising doctors about reports of a new finding of fatal liver injury associated with the use of tolcapone and recommending significant changes in how it is used. Because of these reports, tolcapone labeling now states that the drug should be reserved for use only in patients who do not have severe movement abnormalities and who do not respond to or who are not appropriate candidates for other available treatments.

FDA Talk paper