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Archived - Potential interaction of Proton Pump Inhibitors (PPIs) with Plavix (clopidogrel) - For the Public
- Starting date:
- August 20, 2009
- Posting date:
- August 20, 2009
- Type of communication:
- Public Communication
- Source of recall:
- Health Canada
- General Public
- Identification number:
This is duplicated text of a letter from sanofi-aventis Canada Inc. and Bristol-Myers Squibb.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Plavix (clopidogrel)
August 20, 2009
Subject: Potential drug interaction between Proton Pump Inhibitors (PPIs) and Plavix® (clopidogrel)
Sanofi-aventis Canada Inc. and Bristol Myers Squibb Canada Co., in collaboration with Health Canada, would like to inform you of a potential drug interaction between proton pump inhibitors (PPIs) and Plavix®. PPIs are used to treat stomach ulcers and heartburn and Plavix® is used to prevent blood clots that could lead to life-threatening events such as heart attack or stroke. This update is due to recent reports in the scientific literature suggesting a potential interaction that may reduce the effect of Plavix®.
- Healthcare professionals and patients should be aware of a potential interaction between PPIs and Plavix® that may reduce the effect of Plavix® and therefore reduce its ability to prevent events such as heart attack or stroke.
- Patients currently taking Plavix® should continue to take their Plavix® as directed. Patients should talk to their doctor if they are currently taking or are considering taking a PPI, as there are alternative therapies for the treatment of stomach ulcers and heartburn.
The Canadian prescribing information for Plavix® is being revised to provide doctors, pharmacists and patients with updated information regarding this potential interaction. Patients should discuss all their current medications with their healthcare professionals.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious drug interaction with a PPII or other serious or unexpected adverse reactions in patients taking Plavix® should be reported to sanofi-aventis Canada Inc. or Health Canada at the following addresses:
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec, H7L 4A8
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
For other inquiries related to this communication, please contact Health Canada at: Marketed Health Products Directorate (MHPD)
For media enquiries:
Christian Marcoux, Director of Communications
1-877-904-2667 or 514-904-2667
original signed by
Laurent-Didier Jacobs, M.D.
Vice President, Medical Affairs
sanofi-aventis Canada Inc
original signed by
H. Mitchell Shulman, MDCM, FRCPC, CSPQ
Vice President, Medical
Bristol-Myers Squibb Canada Co.
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