Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of an Inflammatory Disease that Affects One or More Organs (Sarcoidosis)

January 08, 2018

Product

Avonex (interferon beta-1a)

Potential Safety Issue

An inflammatory disease that affects one or more organs (sarcoidosis)

Key Messages

  • Avonex is used to treat some forms of multiple sclerosis (MS), a disease of the central nervous system.
  • Health Canada recently reviewed the potential risk of sarcoidosis linked to the use of Avonex after finding international reports of this risk in individuals treated with Avonex.
  • Health Canada’s review of the available information did not establish a link between the use of Avonex and the risk of sarcoidosis. Health Canada will continue to monitor the safety of Avonex.

Overview

During routine regulatory activities, Health Canada found international reports that indicated a possible link between the use of Avonex and sarcoidosis. Given this, Health Canada recently reviewed the potential risk of sarcoidosis linked to the use of Avonex. Sarcoidosis is a disease where lumps (granulomas) form in the body as a result of inflammation. This disease affects several organs in the body, particularly the lungs (pulmonary sarcoidosis), the nervous system (neuro-sarcoidosis), and the skin (cutaneous sarcoidosis).

Use in Canada

  • Avonex is a prescription medication which is authorized for sale in Canada to treat some forms of multiple sclerosis (MS). It reduces damage to the central nervous system, and thus slows down the worsening of the disease.
  • Avonex is given by injection into the muscle once a week.
  • Avonex has been marketed in Canada since 2005 as a liquid in pre-filled syringes, and since 2011 as a liquid in pre-filled auto injectors.

Safety Review Findings

  • At the time of the review, Health Canada had not received any Canadian reports of sarcoidosis in MS patients who had been treated with Avonex.
  • This safety review looked at 81 international sarcoidosis reports with Avonex use in the World Health Organization’s Adverse Drug Reaction Database, almost all of which were considered serious by the reporting healthcare professionals. Among these, only 5 reports had enough information to be further assessed, one of which was found to be directly linked to treatment with Avonex.
  • The manufacturer also provided 102 international reports of sarcoidosis with Avonex use. Among these, 15 reports met the criteria for further assessment by Health Canada. Although 14 of the 15 reports were considered possibly linked to Avonex, none were found to be directly linked to its use.
  • Health Canada could not conclude from this review whether Avonex played a role in the development of sarcoidosis. The development of sarcoidosis in individuals using Avonex was not found to be greater than in the general population. Other factors, such as the large number of individuals using this medication over a 20-year market presence, use of other medications, presence of other medical conditions, and the increased risk of sarcoidosis in MS patients, also contributed to this conclusion.
  • A search of the scientific literature identified 10 reports of sarcoidosis in patients who had been treated with interferon beta-1a, the active ingredient found in Avonex. Of these reports, only 1 included treatment with the brand Avonex. A link between sarcoidosis and Avonex could not be made in this particular report because of the use of other medications at the same time, or the presence of other health problems.

Conclusions and Actions

  • Health Canada’s review of the available information did not find a link between the use of Avonex and the risk of sarcoidosis.
  • Health Canada has asked the manufacturer of Avonex to actively monitor the risk of sarcoidosis in patients worldwide and to report these to Health Canada.
  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of this and other health products.
  • Health Canada will continue to monitor safety information involving Avonex, 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 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 currently known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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