Archived - For the Public - Reports of Bowel Obstruction and Gastrointestinal Perforation with Rituxan (rituximab)

Starting date:

November 10, 2006

Posting date:

November 14, 2006

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000466

This is duplicated text of a letter from Hoffmann-La Roche Limited.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

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