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Reports of Bowel Obstruction and Gastrointestinal Perforation with Rituxan (rituximab) - For the Public
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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 Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on Rituxan (rituximab)
November 10, 2006
Subject: Reports of Bowel Obstruction and Perforation with RITUXAN® (rituximab)
Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian health care professionals of important safety information concerning RITUXAN® (rituximab).
RITUXAN® has been authorized for use in Canada since 2000 and is used to treat non-Hodgkin's lymphoma (a cancer of the lymph nodes) and rheumatoid arthritis. Please note the following new safety information:
- Bowel obstruction (blockage of the small or large intestine) and bowel perforation (development of a hole in the small or large intestine) have been observed in patients receiving RITUXAN®. Some deaths have occurred in non-Hodgkin's lymphoma patients who were receiving RITUXAN®.
- A relationship between RITUXAN® and these events has not been clearly established.
- The average time for RITUXAN® patients to develop bowel perforation was 6 days from the start of therapy.
- Patients who experience abdominal pain, especially early in treatment, should contact their physician immediately.
Most of the reports of bowel obstruction and perforation associated with RITUXAN® use occurred in patients taking this drug for non-Hodgkin's lymphoma. In addition, it should be noted that most patients had other underlying medical conditions and were undergoing other treatments such as chemotherapy, steroids, and radiation therapy.
There have been 2 cases of bowel obstruction (1 death) and 2 cases of bowel perforation reported in Canada.
Signs and symptoms of bowel obstruction may include:
- nausea
- vomiting
- abdominal swelling
- abdominal pain
- constipation or diarrhea
Signs and symptoms of gastrointestinal perforation include:
- sudden onset of abdominal pain, worsened by movement
- abdominal tenderness
- high fever, chills
- nausea
- vomiting
Bowel obstruction and perforation are serious conditions that require immediate medical attention. Patients who experience the above symptoms or any other unusual symptoms should contact their physician immediately.
The prescribing information for RITUXAN® has been revised to include this updated information, and can be found at the following link: 
http://www.rochecanada.com/pdf/rituxanHPE.pdf.
This advisory is in addition to a letter issued to health care professionals concerning this information. The letter can be accessed at Health Canada's website via the following link: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2006/index-eng.php
Hoffmann-La Roche Limited continues to work closely with Health Canada to monitor adverse event reporting and to ensure that up-to-date information regarding the use of RITUXAN® is available. 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.
Serious or unexpected adverse reactions in patients receiving RITUXAN® should be reported to Hoffmann-La Roche Ltd. or Health Canada, at the following addresses:
Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, ON L5N 6L7
or call toll-free at 1-888-762-4388
or Fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
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 Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel : (613) 954-6522
Fax : (613) 952-7738
Sincerely,
Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
