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>Subject: Panel Recommendations Regarding Tolcapone >Date: Fri, 18 Feb 2000 11:09:19 -0600 > >Tolcapone and hepatotoxic effects >CW Olanow, and the Tasmar Advisory Panel >Arch Neurol 2000;57:263-267 >http://archneur.ama-assn.org/issues/v57n2/full/nob8443.html > >The risk of developing irreversible liver injury from tolcapone is >negligible with proper monitoring, according to this editorial. >Tolcapone was withdrawn from European and Canadian markets, and its >approved use restricted in the United States, following the deaths >of three patients due to liver failure while on the drug, and severe >liver damage in a fourth. > >In this article, the authors review these four cases in detail, and >summarize observations related to liver function from all clinical >trials of tolcapone. The authors note: >--in all four patients, liver dysfunction began within 6 months of >treatment >--recommended guidelines regarding liver function monitoring were not >followed in any of the four, and three had no monitoring at all >--no case of severe hepatic dysfunction has been reported in a patient >for whom the recommended monitoring and withdrawal guidelines have been >followed. > >The authors conclude, "It is our opinion that with the new monitoring >schedule, the risk for development of irreversible liver injury is >virtually negligible...We further believe that the threshold for >initiating therapy is too high and for discontinuing it is too low. >We...suggest that less frequent monitoring after 6 months with an action >limit of 2 to 3 times the upper limit of normal will likely be sufficient >to ensure safety in patients who are deriving benefit from the drug." > >The Tasmar Advisory Panel consists of 16 physicians from 15 centers across >the United States. The Panel was supported by Roche Laboratories, makers >of Tasmar. > >Copyright 2000 WE MOVE > >E-MOVE is a service of WE MOVE (Worldwide Education and Awareness for >Movement Disorders) >204 West 84th Street >New York, NY 10024 >TEL 800-437-MOV2 >TEL 212-241-8567 >FAX 212-987-7363 >http://www.wemove.org janet paterson 52 now / 41 dx / 37 onset a new voice: http://www.geocities.com/janet313/ 613 256 8340 PO Box 171 Almonte Ontario Canada K0A 1A0