|
Health Canada is informing Canadians that Permax, a drug used for the treatment of Parkinson's disease, has been withdrawn from the U.S. market amidst concerns about an association with cardiac valvulopathy, a condition involving inflammation or stiffening of the heart valves.
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 disease.
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.
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.
|
More
