Summary Safety Review - REMICADE (infliximab) - Evaluating for the Risk of Cancer (Lymphoma, Hepatosplenic T-Cell Lymphoma, and Leukemia)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2015-09-29

Product

Remicade (infliximab)

Potential Safety Issue

Blood cancers (lymphoma, hepatosplenic T-cell lymphoma, and leukemia)

Key Messages

  • Remicade treats inflammation that results from the body's own defence system attacking the skin, joints, intestines, or stomach (autoimmune disease).
  • Health Canada conducted a safety review to evaluate the risk of developing three types of cancers (lymphoma, hepatosplenic T-cell lymphoma, and leukemia) associated with the use of Remicade to treat an autoimmune disease of the skin (psoriasis) in adults.
  • This issue was identified during Health Canada's review of safety information provided by the manufacturer.
  • Health Canada's safety review did not find evidence of an association between lymphoma, hepatosplenic T-cell lymphoma, or leukemia, and the use of Remicade to treat psoriasis. Health Canada will continue to monitor this issue, including the assessment of medical and scientific literature and side effect reports.

Overview

Use in Canada

  • Remicade (infliximab) is a unique immune system protein (monoclonal antibody), which works by blocking a naturally occurring chemical TNF-α (Tumour Necrosis Factor-alpha) that causes inflammation.
  • This medicine treats inflammation that results from the body's own defence system attacking the skin, joints, intestines, or stomach (autoimmune disease). Remicade is used for the treatment of autoimmune diseases including plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, adult and children's ulcerative colitis and Crohn's disease.
  • Remicade has been marketed in Canada since 2001, and is available by prescription only.

Safety Review Findings

  • At the time of the review, the Canada Vigilance Programa received 77 reports of lymphoma, 5 reports of a type of lymphoma (Non-Hodgkin's Lymphoma) that also included cases of hepatosplenic T-cell lymphoma, and 8 reports of leukemia associated with the use of Remicade to treat autoimmune diseases. Health Canada's analysis of the reports found no association between these cancers with Remicade use for psoriasis.
  • A review of international safety data provided by the manufacturer revealed cases of lymphoma and leukemia associated with Remicade treatment for psoriasis and psoriatic arthritis. No cases of hepatosplenic T-cell lymphoma were identified.
  • A review of international data from the World Health Organization's database retrieved 413 reports of lymphoma, 73 reports of Non-Hodgkin's Lymphoma that included cases of hepatosplenic T-cell lymphoma, and 50 reports of leukemia associated with Remicade treatment of autoimmune diseases. Health Canada's evaluation of these reports did not indicate that these cancers were associated with Remicade treatment for psoriasis in particular.
  • A review of the scientific and medical literature did not identify an association between lymphoma, hepatosplenic T-cell lymphoma, and leukemia and the use of Remicade for the treatment of psoriasis or psoriatic arthritis.
  • Confirming and assessing these reports was limited by several factors, including an increased risk of cancer in patients having certain underlying diseases or having taken, or currently taking other medications.

Conclusions and actions

  • Health Canada's safety review did not find evidence of an association between lymphoma, hepatosplenic T-cell lymphoma, and leukemia and the use of Remicade for psoriasis.
  • The Canadian prescribing information already includes the potential risk of developing hepatosplenic T-cell lymphoma in patients receiving Remicade for the treatment of autoimmune diseases. In 2004, Health Canada also issued a healthcare professional communication and a public communication about updated safety information addressing the risk of cancers linked to the use of Remicade.
  • Health Canada will continue to monitor side effect information involving Remicade, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take right and timely action if and when any new health risks are identified.

Additional information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.

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