OTTAWA, March 31 /CNW Telbec/ - Health Canada is informing Canadians that
Permax, a drug used for the treatment of Parkinson's disease, has been
withdrawn from the U.S. market amidst concerns about an association with
cardiac valvulopathy, a condition involving inflammation or stiffening of the
Permax (a brand name of the drug pergolide) has been marketed in Canada
since 1991 for the treatment of Parkinson's disease. The risk of heart valve
problems has been known with this drug and is in the current labelling. Health
Canada communicated information regarding this risk to Canadian healthcare
providers and patients in 2003 and again in 2004.
Two new studies regarding the risk of heart valve problems associated
with Permax were published in January 2007. Health Canada is in the process of
reviewing these studies and other information to determine what further action
will be required regarding Permax. Results of this review will be communicated
to the Canadian public and healthcare providers as soon as it is available.
Appropriate regulatory action will be taken as necessary.
Every drug has benefits and risks associated with its use. In assessing a
drug, Health Canada must balance the risks with the benefits. When the risks
associated with a product under its current conditions of use are determined
to no longer be acceptable, steps are taken ranging from a change in the
conditions of use to withdrawing the product from the market.
Patients should contact their physician or pharmacist if they have
questions about Permax or any medication used in the treatment of Parkinson's
Health Canada stresses that patients should not stop taking their
medication without first consulting with their doctor as sudden
discontinuation of Permax may be associated with serious side effects.
Consumers requiring more information about this Information Update can
contact Health Canada's public enquiries line at (613) 957-2991, or toll free
Any serious or unexpected adverse reactions in patients receiving Permax
or any other drug should be reported to the Canadian Adverse Drug Reaction
Monitoring Program (CADRMP) of Health Canada by one of the following methods:
CADRMP Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
The CADRMP adverse reaction reporting form, including a version that can
be completed and submitted online, is located on the MedEffect
(www.medeffect.gc.ca) portal of the Health Canada Web site.
Egalement disponible en français
For further information:
For further information: Media Inquiries: Health Canada, (613) 957-2983;
Public Inquiries: (613) 957-2991, 1-866 225-0709