Summary Safety Review - Finasteride - Assessing the Potential Risks of Suicide, Suicidal Thoughts (Suicidal Ideation) and Self-injury

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: 2023-01-19

Product

Finasteride-containing products

Potential Safety Issue

Suicide, suicidal thoughts (suicidal ideation) and self-injury

Key Messages

  • Finasteride is authorized for sale in Canada for the treatment and control of prostate gland enlargement (benign prostatic hyperplasia), and for the treatment of male pattern hair loss (androgenetic alopecia).
  • Health Canada reviewed the risk of suicidal ideation and potential risks of suicide and self-injury with the use of finasteride. The safety review was triggered by the publication of a media article that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss.
  • Health Canada's review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link for the risk of suicide.
  • Health Canada is working with the manufacturers to update the product safety information in the Canadian product monographs (CPM) for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment.
  • Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

Overview

Health Canada has been monitoring the risk of suicidal ideation with the use of finasteride since 2012. Health Canada completed 2 safety reviews in 2012 and 2015, and the information available at the time was considered too limited to determine whether there was a link between the use of finasteride and suicidal thoughts and behaviours (suicidality).

In 2019, following reports of Canadian and international cases of suicide, suicidal ideation and self-injury with the use of finasteride, Health Canada completed a third safety review that found a possible link between finasteride and the risk of suicidal ideation. The CPMs of finasteride were updated to include the risk of suicidal ideation.

In 2022, Health Canada completed a review of the risk of suicidal ideation and potential risks of suicide and self-injury with the use of finasteride. This latest safety review was triggered by the publication of a media article1 that discussed the potential risk of suicide in patients using Propecia (finasteride) for male pattern hair loss. The purpose of the current review was to consider recent information and determine if additional measures were warranted.

Use in Canada

  • Finasteride is a prescription drug authorized for sale in Canada for the treatment and control of prostate gland enlargement (benign prostatic hyperplasia), and for the treatment of male pattern hair loss (androgenetic alopecia).
  • Finasteride has been marketed in Canada since 1992 under the brand name Proscar (5 mg tablets), and since 1998 under the brand name Propecia (1 mg tablets). Generic versions of finasteride are also available on the Canadian market.
  • Approximately 8.7 million prescriptions of finasteride were dispensed by Canadian retail pharmacies between 2016 and 2022.

Safety Review Findings

  • Health Canada reviewed the available information from searches of the Canada Vigilance databasea, the World Health Organization’s Adverse Drug Reaction databaseb, and the scientific literature.
  • Health Canada reviewed 401 cases (29 Canadian and 372 international) of suicide, suicidal ideation and/or self-injury in patients using finasteride from the Canada Vigilance database. Of the 401 cases, 25 (10 Canadian) met the criteria for further assessment to determine if there was a link between the use of finasteride and suicide, suicidal ideation and self-injury.
  • Of the 25 cases, 23 (9 Canadian) were found to be possibly linked to the use of finasteride. Two cases (1 Canadian) could not be assessed. Eight of the 14 international cases were fatal (resulted in a completed suicide).
  • In 17 of the 25 cases assessed by Health Canada, patients were 40 years of age or younger and taking finasteride for male pattern hair loss.
  • The number of cases of suicide, suicidal ideation and self-injury reported to Health Canada is considered to be low in individuals treated with finasteride (approximately 1 Canadian case for every 10.1 million tablets dispensed in Canada).
  • Health Canada also reviewed 16 publications in the scientific literature. There is a growing body of scientific evidence regarding the association between the use of finasteride and the risks of suicide, suicidal ideation and self-injury. Although there were limitations, the publications reviewed supported a possible link between the use of finasteride and suicidal ideation during treatment and following discontinuation of finasteride, especially in patients treated for male pattern hair loss.

Conclusions and actions

  • Health Canada’s review of the available information found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury. At this time, there is not enough information to establish a link between the use of finasteride and the risk of suicide.
  • Health Canada is working with the manufacturers to update the CPMs for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment.
  • 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 finasteride and other health products to the Canada Vigilance Program.
  • Health Canada will continue to monitor safety information involving 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 should any new health risk 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 finasteride both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Levine, D., Terhune, C., "Exclusive: Merck anti-baldness drug Propecia has long trail of suicide reports, records show," REUTERS, February 3, 2021.

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