Summary Safety Review - Imatinib mesylate (GLEEVEC and generics) - Assessing the potential risk of tendon disorders

June 8, 2018

Product

Imatinib mesylate (Gleevec and generics)

Potential Safety Issue

Disorders affecting tendons

Key Messages

  • Imatinib is a drug authorized for sale in Canada to treat cancer (chemotherapy). It is used to treat several solid tumours or blood cancers.
  • Health Canada reviewed the potential risk of tendon disorders with the use of imatinib after receiving Canadian and international reports of tendon disorders in patients treated with Gleevec.
  • Health Canada's review of the available information did not find a link between the use of imatinib and the risk of tendon disorders. Health Canada will continue to monitor the safety of products containing imatinib.

Overview

Health Canada carried out a safety review after receiving Canadian and international reports of tendon disorders in patients treated with Gleevec.

Tendon disorders are medical conditions that result in the tendons not functioning normally. A tendon is a flexible but non-elastic piece of tissue in the body that attaches a muscle to a bone.

Use in Canada

  • Imatinib belongs to a class of cancer drugs called tyrosine kinase inhibitors. It is used to treat several solid tumours such as certain tumours of the gastrointestinal tract, or blood cancers such as chronic myeloid leukemia.
  • Imatinib has been marketed in Canada since 2001 under the brand name Gleevec. It is available as tablets taken by mouth.
  • Generic versions of imatinib are also available.

Safety Review Findings

  • The review identified 6 CanadianFootnote a and 36 international reports of tendon disorders in patients treated with Gleevec that had enough information for assessment. The review of these reports could not conclude whether the tendon disorders were caused by imatinib. Other reasons could have explained the events that were observed, such as accidents, the presence of other diseases (e.g., diabetes), and the use of other medication (e.g., quinolone antibiotics) known to cause tendon disorders.
  • A search for published information found 1 long-term safety study that reported 3 serious cases of tendon injury among 832 patients treated with imatinib for more than 2 years. However, there was not enough information to further assess these cases.
  • At the time of the review, there have been no international regulatory actions taken with respect to this issue.

Conclusions and Actions

  • Health Canada's review of the available information did not find a link between the use of imatinib and the risk of tendon disorders.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this health product.
  • Health Canada will continue to monitor safety information involving imatinib to identify and assess potential harms, as it does for all health products on the Canadian market. Health Canada will take appropriate and timely action if and when any new health risks are 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

Footnote 1

Canadian reports can be accessed through the Canada Vigilance Online Database.

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