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RELISTOR (methylnaltrexone bromide) Subcutaneous Injection - Association with Gastrointestinal Perforation - For Health Professionals
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(PDF Version - 226 K)Contact: Marketed Health Products Directorate
The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Wyeth Canada.
Contact the company for a copy of any references, attachments or enclosures.
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:
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 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
- Health Canada
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
