Summary Safety Review - Bortezomib - Assessing the Potential Risk of Drug Reaction with Eosinophilia and Systemic Symptoms

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.


Product
Bortezomib-containing products
Potential Safety Issue
Drug reaction with eosinophilia and systemic symptoms (DRESS), a type of allergic drug reaction with rash, fever, increased white blood cell count, and injury to 1 or more organs
Key Messages

  • Health Canada’s safety review found a possible link between the use of bortezomib and the risk of DRESS.

  • Health Canada will work with the manufacturers to update the product safety information in the Canadian product monograph (CPM) for all bortezomib-containing products to include the risk of DRESS. Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

Overview

Health Canada reviewed the potential risk of DRESS with the use of bortezomib. The safety review was triggered by a notification of foreign action received from a manufacturer.

Use in Canada

  • Bortezomib is a prescription drug authorized for sale in Canada to treat adults with multiple myeloma (cancer that forms in a type of white blood cell called a plasma cell) and mantle cell lymphoma (an aggressive type of non-Hodgkin lymphoma, a cancer that affects a type of white blood cells called B lymphocytes, which are part of the immune system).

  • Bortezomib has been marketed in Canada since 2005, under the brand name Velcade. It is currently available as a lyophilized (freeze-dried) powder or liquid. Generic versions are also available.

Safety Review Findings

  • Health Canada reviewed the available information provided by a manufacturer, as well as from searches of the Canada Vigilance databasea and the scientific literature.

  • At the time of the review, Health Canada had not received any Canadian reports of DRESS in patients treated with bortezomib.

  • Health Canada reviewed 29 international cases of DRESS in patients treated with bortezomib. Although the use of other medications was a confounder (other factor that may have been responsible for the occurrence of DRESS) in all 29 cases, 27 of those cases were found to be possibly linked to the use of bortezomib. Two of the 29 cases were unlikely to be linked. One death was reported among the 29 cases reviewed, which was possibly linked to the use of bortezomib.

  • Health Canada also reviewed 1 article published in the scientific literature. Due to important limitations regarding the design and analysis of the study, the evidence did not strongly support a link between the use of bortezomib and the risk of DRESS.

Conclusions and Actions

  • Health Canada’s review found a possible link between the use of bortezomib and the risk of DRESS.

  • Health Canada will work with the manufacturers to update the CPM for all bortezomib-containing products to include the risk of DRESS.

  • Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of bortezomib, and other health products, to the Canada Vigilance Program.

  • Health Canada will continue to monitor safety information involving bortezomib, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of bortezomib 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 Online Database.

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