Advisory
1998-88
November 23, 1998
Liver complications reported with anti-Parkinson's drug TASMAR
OTTAWA - The Therapeutic Products Programme (TPP) of Health Canada is advising patients with Parkinson's disease who are using the drug TASMAR ® (tolcapone) to immediately contact their physician because of the potential for serious liver complications. TASMAR ® is a supplemental drug to antiparkinsonian therapy and is manufactured by Hoffman-La Roche. It is used with other medications to manage the severe movement abnormalities associated with Parkinson's. To date, three deaths from irreversible liver damage associated with use of this drug have been reported worldwide, including one death in Canada. In addition, eight cases of serious liver injury in patients taking TASMAR ® have been reported worldwide. The TPP continues to evaluate new safety data as it emerges. In October 1998, following initial reports of two deaths outside Canada, Hoffmann-La Roche, in consultation with TPP, sent letters to all Canadian physicians and pharmacists alerting them to this situation. The letters recommend increased monitoring of liver function for patients prescribed the drug. Following the death in Canada and under authority of the Food and Drug Regulations, TPP has immediately suspended all sales of TASMAR ®. The drug will continue to be available with restrictions through the Special Access Programme (SAP). It is important that patients using TASMAR ® not stop taking the drug on their own, as complications can arise from sudden withdrawal. Physicians and pharmacists will be advised in a letter from Hoffman-La Roche on how to withdraw the product. The manufacturer has also established the toll-free number 1-888-990-7171 for patients and health care professionals who have questions about TASMAR ®. Those continuing to use TASMAR ® should be monitored for liver abnormalities during treatment.
TASMAR ® was first marketed in Canada in late 1997. To date some 1,500 patients in Canada have been prescribed the drug and some 100,000 patients have been treated with the drug worldwide. Patients with questions or concerns should consult with their physician to discuss other treatment options that are available.
Inquiries:
JoAnne Ford/Bonnie Fox-McIntyre
Health Canada
(613) 957-1588
|
