Summary Safety Review - Aimovig (erenumab) - Assessing the Potential Risks of Non-Fatal Stroke, Non-Fatal Heart Attack and Cardiovascular Death

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: 2021-12-08

Product

Aimovig (erenumab)

Potential Safety Issue

Non-fatal stroke, non-fatal heart attack and death related to diseases affecting the heart and blood vessels (cardiovascular death)

Key Messages

  • Aimovig (erenumab) is a prescription drug authorized for sale in Canada to prevent migraines in adults who have 4 or more migraine days per month.
  • Health Canada reviewed the risks of non-fatal stroke, non-fatal heart attack and death related to the diseases affecting the heart and blood vessels (cardiovascular death) with the use of Aimovig. This review was triggered by new safety information, related to these potential risks, received from the manufacturer.
  • Health Canada's review of the available information could not confirm a link between the use of Aimovig and the risks of non-fatal stroke, non-fatal heart attack or cardiovascular death.
  • Health Canada will continue to monitor the safety of Aimovig, as it does for all health products on the Canadian market.

Overview

Health Canada reviewed the potential risk of non-fatal stroke, non-fatal heart attack and cardiovascular death with the use of Aimovig. This safety review was triggered by new information from safety reports, related to these potential risks, received from the manufacturer.

A stroke happens when the blood supply to part of the brain is stopped or lowered, blocking brain tissue from getting enough oxygen and nutrients, leading to the death of brain cells. A heart attack happens when blood flow, bringing oxygen and nutrients, to the heart muscle is lowered or cut off completely. The heart muscle may be damaged, and heart function could be weakened. Depending on the extent of the brain or heart tissue injury, there could be long-term health consequences or cardiovascular death in rare situations.

Use in Canada

  • Aimovig is a prescription drug authorized for sale in Canada to prevent migraines in adults who have 4 or more migraine days per month.
  • Erenumab, the active ingredient in Aimovig, is a monoclonal antibody that blocks the function of a protein called calcitonin gene-related peptide that can cause a migraine.
  • Aimovig is authorized to be sold as 70 mg/mL and 140 mg/mL solutions for injection under the skin (subcutaneous) through single-dose pre-filled autoinjector or single-dose pre-filled syringe.
  • Aimovig has been marketed in Canada since 2018. Approximately 19,982 new Aimovig prescriptions have been dispensed in Canada to date.

Safety Review Findings

  • Health Canada reviewed information received from the manufacturer, and information from searches of the Canada Vigilance databasea, international databases, and published literature.
  • Health Canada considered 196 case reports (134 international and 62 Canadian) for this safety review. Ten cases (all Canadian) met the criteria for further assessment to determine if there was a link between Aimovig use and the risk of non-fatal stroke, non-fatal heart attack or cardiovascular death.
  • Health Canada's assessment of the 10 Canadian cases could not confirm a link between the use of Aimovig and non-fatal stroke, non-fatal heart attack, or cardiovascular death. These cases either included factors such as other medications taken by the patients or medical conditions that may have contributed to these risks, or contained insufficient medical information.
  • At the time of the review, Health Canada did not find any reports in the scientific literature to support a link between non-fatal stroke, non-fatal heart attack or cardiovascular death and Aimovig use.

Conclusions and actions

  • Health Canada's review of the available information could not confirm a link between the use of Aimovig and non-fatal stroke, non-fatal heart attack or cardiovascular death.
  • Health Canada continues to encourage consumers and healthcare professionals to report any side effects related to the use of Aimovig and other health products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving Aimovig, 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 any 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 Aimovig 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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