Mark Steiner wrote:
> Can you please verify for me that the British and Canadian Health Services have withdrawn Tasmar from public circulation due to reported serious liver damge side-effects.<
November 23, 1998
Advisory 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
AccessProgramme (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.
- 30 -
Inquiries: JoAnne Ford/Bonnie Fox-McIntyre
Health Canada
(613) 957-1588
--
Judith Richards, London, Ontario, Canada
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