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RELISTOR (methylnaltrexone bromide) Subcutaneous Injection - Association with Gastrointestinal Perforation - For Health Professionals
- Starting date:
- July 28, 2010
- Posting date:
- August 3, 2010
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Audience:
- Healthcare Professionals
- Identification number:
- RA-170002349
This is duplicated text of a letter from Wyeth Canada.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
Health Canada Endorsed Important Safety Information on RELISTOR (methylnaltrexone bromide)
July 28, 2010
Subject: Association of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection with gastrointestinal (GI) perforation
Dear Health Care Professional,
Wyeth Canada (a Pfizer Company), in collaboration with Health Canada, would like to inform you of important new safety information added to the Product Monograph for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection.
RELISTOR is indicated for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care. When response to laxatives has been insufficient, RELISTOR is used as an adjunct therapy to induce a prompt bowel movement.
- Patients with advanced illness being treated with RELISTOR may be at increased risk of GI perforation if they have conditions associated with localized or diffused reduction of structural integrity in the GI wall.
- The risks and benefits of Relistor treatment should be weighed for each patient.
- RELISTOR should be used with caution in patients with known or suspected GI lesions.
- RELISTOR therapy should be discontinued if patients develop severe, persistent, and/or worsening abdominal symptoms, as these could be symptoms of GI perforation.
The Canadian Product Monograph (CPM) for Relistor has been revised to include the following information in the Warnings and Precautions section:
Based on post-marketing experience, patients with advanced illness and being treated with RELISTOR may be at increased risk of GI perforation if they have such conditions that may be associated with localized or diffused reduction of structural integrity in the GI wall. These include conditions such as cancer, GI malignancy, GI ulcer, Ogilvie's syndrome, and concomitant medications [e.g. bevacizumab (AVASTIN), Nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids]. Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, and colon).
The current Canadian Product Monograph for RELISTOR can be accessed at http://www.wyeth.ca or at Health Canada's Drug Product Database.
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 GI perforation or other serious or unexpected adverse reactions in patients receiving RELISTOR should be reported to Wyeth Canada or Health Canada at the following addresses:
Wyeth Canada (a Pfizer Company)
Medical Information and Pharmacovigilance
50 Minthorn Boulevard
Markham, Ontario L3T 7Y2
Telephone: 1-800-268-1946, ext 4308
Fax: 1-800-734-5001
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at MedEffect™ Canada Web site - www.healthcanada.gc.ca/medeffect
- 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™ Canada Web site in the Adverse Reaction 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 (MHPD)
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).
A copy of this letter and the Public Communication are available on the Health Canada Web site. These documents can also be viewed on the Wyeth Canada Web site.
Sincerely,
original signed by
Bernard Prigent, MD, MBA.
Vice-President and Medical Director
Reference:
1. RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection Product Monograph, Wyeth Canada. June 24, 2010