Summary Safety Review - Tumour necrosis factor (TNF) blockers - Glioblastoma (brain tumour)

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: 2015-03-18

Product

Tumour necrosis factor (TNF) blockers

Potential Safety Issue

Glioblastoma (brain tumour)

Key Messages

  • TNF blockers are a class of drugs used to treat inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), and psoriasis.
  • A safety review was initiated as part of Health Canada's ongoing monitoring of the safety of these products.
  • Given the evidence available at the time of this review, no increased risk of glioblastoma after exposure to a TNF blocker was found.

Overview

A safety review was initiated to evaluate the currently available information regarding the possibility of an increased risk of the cancerous (malignant) brain tumour called glioblastoma/glioblastoma multiforme following exposure to TNF blockers. This potential safety issue was identified as part of Health Canada's ongoing monitoring of safety information shared by other regulatory agencies.

Use in Canada

  • TNF blockers are used to treat specific inflammatory diseases such as rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's or ulcerative colitis), and psoriasis.
  • At the time of the review, the following TNF blockers were marketed in Canada:
    • CIMZIA (certolizumab; first marketed in Canada in 2009);
    • ENBREL (etanercept; first marketed in Canada in 2001);
    • HUMIRA (adalimumab; first marketed in Canada in 2004);
    • REMICADE (infliximab; first marketed in Canada in 2001); and
    • SIMPONI (golimumab; first marketed in Canada in 2009).

Safety Review Findings

  • Glioblastomas are the most common type of brain tumour. The number of reports of glioblastoma associated with TNF blockers received by Health Canada and internationally fall below or within the expected range for this type of tumour in the general population.a
  • Published analyses that took into consideration a large volume of related literature on this subject (meta-analyses) did not find an increased risk of glioblastoma or other cancers associated with TNF blockers.
  • Observational studies using large, population based databases did not find an increased risk of glioblastoma or other cancers with TNF blockers.

Conclusions and actions

  • Given the evidence available at the time of this review, no increased risk of glioblastoma after exposure to TNF blockers was found.
  • Health Canada will continue its ongoing monitoring of adverse reaction information involving TNF blockers, as it does for all health products on the Canadian market, and assess potential harms.
  • Health Canada will keep Canadians informed and take action, as appropriate, if any new information is identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both 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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