Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation)

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: 2019-02-26

Product

Proscar and Propecia (finasteride)

Potential Safety Issue

Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation)

Key Messages

  • There are two finasteride-containing prescription drug products for oral use sold in Canada. Proscar (5 mg tablet) is indicated to treat prostate gland enlargement (Benign Prostatic Hyperplasia, or BPH), and Propecia (1 mg tablet) for the treatment of hair loss in men.
  • Health Canada reviewed the risk of suicidal thoughts and/or behaviours (suicidal ideation) with Proscar and Propecia (finasteride) use. The safety review was triggered because of Canadian and international reported casesa,b of suicidal ideation and self-injury.
  • Health Canada's review concluded that there may be a link between Proscar and Propecia (finasteride) and the risk of suicidal ideation. Health Canada has notified the manufacturer to update the Canadian product information on this potential safety issue.

Overview

Health Canada reviewed the potential risk of suicidal ideation with use of Proscar or Propecia (finasteride) due to reported cases of suicidal ideation and self-injury received in Canada and internationally. The cases led to the investigation of the possible relationship between finasteride use and suicidal ideation through a number of assessments.

The topic of finasteride and suicide/self-injury has been monitored on an ongoing basis by Health Canada since 2011. A first safety review was completed in 2012, and it was recommended that the topic be re-assessed in 2 years. A second safety review was completed in 2014, where the information at that time could not confirm if there was a link or not between finasteride use and suicide/self-injury. It was recommended as a precautionary measure to inform physicians of the potential risk and assess the topic again after another 2 years. As a result of this recommendation and reported cases, Health Canada began this safety review.

Use in Canada

  • Proscar and Propecia (finasteride) are prescription drugs that are authorized for sale in Canada to treat prostate gland enlargement (benign prostatic hyperplasia or BPH), and male pattern hair loss, respectively.
  • Finasteride has been marketed in Canada since 1992 under the brand name Proscar, and since 1998 under the brand name Propecia. Generic versions of finasteride are also available. Proscar is available as an oral 5 mg tablet and Propecia is available as an oral 1 mg tablet.

Safety Review Findings

  • At the time of the review, Health Canada had received 26 Canadian reportsa of events related to suicide or self-injury with the use of finasteride. Between 2012 and 2016, the Canadian reporting rate for finasteride and suicide/self-injury-related events increased by 2.5 times. In the assessment of the Canadian reports, a cause and effect relationship could not be confirmed or denied, and as a result, a link between finasteride and suicide/self-injury-related events was deemed possible.
  • A search in the World Health Organization's Adverse Drug Reaction Database found 368 international reportsb of suicide/self-injury-related events reported in patients treated with finasteride, up to September 16, 2018.
  • There were 5 studies reviewed that were published between 2015-2018 on finasteride and suicide-related events. These publications support a link between finasteride use and the risk of suicidal ideation.
  • In 2018, the European Medicines Agency (EMA) added a warning in the product information for Proscar and Propecia that suicidal ideation had been reported in patients treated with finasteride (1 mg and 5 mg), and that patients should be monitored for psychiatric symptoms. Currently, the United States Food and Drug Administration has not required labelling for this risk for Proscar or Propecia.
  • The international reports, literature, and regulatory information that were reviewed could neither confirm nor deny a cause and effect relationship between finasteride and suicide/ self-injury.

Conclusions and actions

  • Health Canada's review concluded that there may be a link between Proscar and Propecia (finasteride) and the risk of suicidal ideation.
  • Health Canada has notified the manufacturer to update the Canadian product information to include a warning on this potential safety issue.
  • Health Canada will continue to monitor safety information related to Proscar and Propecia (finasteride), 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 information, 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 Online Database.
  2. World Health Organization Adverse Drug Reaction Database was accessed through VigiBase.

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