This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Archived – Important Safety Information about the Risk of Heart Valve Problems for Patients Taking PERMAX® – For the Public
- Starting date:
- April 17, 2003
- Posting date:
- April 23, 2003
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public
- Identification number:
- RA-1900085
This is duplicated text of a letter from Eli Lilly Canada Inc. and Draxis Health Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
PUBLIC ADVISORY
Risk of Heart Valve Problems Associated with PERMAX®
Important Safety Information about the Risk of Heart Valve Problems for Patients Taking PERMAX®
April 17, 2003 - In consultation with Health Canada, Canadian health care professionals have been informed of clinically important new safety information concerning PERMAX® (pergolide mesylate) tablets, a drug prescribed for the treatment of Parkinson's disease.
Based on worldwide data and scientific publications, a small number of individuals have been identified as developing heart valve problems during PERMAX® therapy. Of the estimated 500,000 people who have been treated with pergolide worldwide since 1989, heart valve problems have been reported very rarely (less than 1 in 20,000 patients).
Symptoms of heart valve problems may vary depending on which valve is damaged, the severity of damage, how quickly the damage occurred, and how well the heart adjusts to the increased workload. In some cases, patients who develop heart valve problems may experience no symptoms at all. In other cases, symptoms may develop suddenly or over a long period of time. Some of the common symptoms associated with heart valve problems include:
- Shortness of breath (especially with exertion)
- Fatigue and exhaustion (especially with exertion)
- Dizziness or fainting spells
- Sensations of rapid, fluttering heartbeat
- Chest pain or chest tightness
- Swelling of the ankles or feet
- Increased blood pressure
If you are taking PERMAX® and you experience any of the above symptoms or if you have a history of heart problems, it is important that you contact your physician immediately. Because these symptoms may be unrelated to PERMAX® therapy, PERMAX® should not be discontinued without consulting your physician.
This advisory is in addition to a letter issued to health care professionals discussing the above-mentioned safety information. This information can be accessed at www.draxis.com. As well, the Product Monograph for PERMAX® is being revised to provide physicians and pharmacists with safety information on heart valve problems.
Patients who have any questions about their current prescription should contact their physician or pharmacist directly.
Suspected adverse reactions can be reported directly to Draxis Health Inc.
Attn: Medical and Regulatory Affairs
Draxis Health Inc.
6870 Goreway Drive
Mississauga, Ontario, L4V 1P1
Telephone: (866) 460-9885 (toll free)
Fax: (905) 677-9263
® PERMAX is a registered trademark of Eli Lilly and Company, and is licensed exclusively in Canada to Draxis Health Inc.
Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or
Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345,
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.