Pradax (dabigatran etexilate) and Plavix (clopidogrel bisulfate) - Risk of Potential Patient Harm Associated with Brand Name Confusion - For Health Professionals

Starting date:

November 3, 2011

Posting date:

November 8, 2011

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002494

This is duplicated text of a letter from Boehringer Ingelheim (Canada) Ltd. and sanofi-aventis Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Pradax and Plavix

November 3, 2011

Dear Health Care Professional,

Subject: Risk of potential patient harm associated with brand name confusion involving Pradax^® (dabigatran etexilate) and Plavix^® (clopidogrel bisulfate)

Boehringer Ingelheim (Canada) Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership) in consultation with Health Canada, would like to alert you to the risk of medication errors associated with name confusion between the anticoagulant Pradax^® (dabigatran etexilate) from Boehringer Ingelheim (Canada) Ltd. and the antiplatelet drug Plavix^® (clopidogrel bisulfate) from sanofi-aventis Canada Inc.

Since January 2011, a total of 5 Canadian cases, associated with drug name confusion between Pradax^® and Plavix^®, have been received by Boehringer Ingelheim (Canada) Ltd. and Health Canada, including 1 case resulting in patient harm (non-serious bleeding after a medical procedure). An additional 2 reports of concern were received from health care professionals about the potential for confusion between the names of these two drugs.

• The Pradax^® and Plavix^® names, verbally and by script have been mistaken for one another. These mix-ups have been associated with similarities in orthographics, phonetics, strength, and use in patients with cardiovascular disorders.
• Receiving Pradax^® instead of Plavix^® or vice versa, may result in patient harm, including increased risk of bleeding, stroke, systemic embolism, venous thromboembolic events (VTE), atherothrombotic events or other unknown medical outcomes.
• The patient is also at risk of receiving incorrect concomitant medications or medical procedures when Pradax^® or Plavix^® is noted in patient history in error as a result of name confusion.
• To reduce the potential for name confusion errors, healthcare professionals are encouraged to include the generic name dabigatran when referring to Pradax^®, or the name clopidogrel when referring to Plavix^®. Spelling the name of the medication for verbal prescriptions or medication reconciliation (e.g. emergency room triage), is also suggested.

Pradax^® (dabigatran), an oral anticoagulant (direct thrombin inhibitor), was first marketed in Canada in 2008, for the prevention of VTE in patients following hip or knee replacement surgery. In October 2010, Pradax^® received a new indication for prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate. Pradax^® is available in 75mg, 110mg and 150mg capsules.Footnote 1

Plavix^®(clopidogrel), an oral platelet aggregation inhibitor, was first marketed in Canada in 1998, for use as secondary prevention of atherothrombotic events (myocardial infarction or stroke) in patients with atherosclerosis. Plavix^® is also indicated in combination with ASA for the prevention of atherothrombotic events in patients with acute coronary syndromes. In February 2011, Plavix^® received a new indication, in combination with low-dose ASA, for the prevention of stroke in patients with atrial fibrillation, who are not suitable for treatment with an anticoagulant. Plavix^® is available in 75mg and 300mg tablets.^{Footnote 2}

Boehringer Ingelheim Canada Ltd., and sanofi-aventis Canada Inc. (on behalf of Bristol-Myers Squibb Sanofi Canada partnership), in consultation with Health Canada, are working on measures to reduce the risk associated with medication errors related to name confusion issues between Pradax^® and Plavix^®.

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 medication errors relating to name confusion between Pradax^® and Plavix^® should be reported to Boehringer Ingelheim (Canada) Ltd., sanofi-aventis Canada Inc, or Health Canada. Serious or unexpected adverse reactions in patients receiving Pradax^® should be reported to Boehringer Ingelheim (Canada) Ltd. or Health Canada. Any case of serious or unexpected adverse reactions in patients receiving Plavix^® should be reported to sanofi-aventis Canada Inc. or to Health Canada. Medication incidents/errors can also be reported to the Institute for Safe Medication Practices (ISMP) Canada through the Canadian Medication Incident Reporting and Prevention System.

Boehringer Ingelheim (Canada) Ltd.,
5180 South Service Rd.
Burlington, ON, L7L 5H4
Tel: 1 (800) 263-5103 Ext. 84603.
Boehringer Ingelheim (Canada) Ltd

sanofi-aventis Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Phone: 1-800-265-7927

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at MedEffect Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario  K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction and Medical Device Problem Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

For full prescribing and dosing information for Pradax^® see Product Monograph.^{Footnote 1} For full prescribing and dosing information for Plavix^® see Product Monograph.^{Footnote 2}

A copy of this letter can be found on the Boehringer Ingelheim (Canada) Ltd., website and also at the sanofi-aventis Canada Inc. site.

Sincerely,

original signed by

Mathias Knecht, M.D.
Vice President, Medical and Regulatory Affairs
Boehringer Ingelheim (Canada) Ltd.

Franca Mancino, M.Sc.
Senior Director, Regulatory Affairs, Pharmacovigilance & Medical Quality and Compliance
sanofi-aventis Canada Inc.