Summary Safety Review - Finasteride - Assessing the Potential Risk of Suicidal Thoughts and Behaviour (Suicidality)

December 17, 2015

Product

Finasteride

Potential Safety Issue

Suicidal thoughts and behaviour (suicidality)

Key Messages

• Finasteride is a drug that is used to treat and control benign prostatic hyperplasia (non-cancerous enlargement of the prostate gland). At a lower dose, it is used to treat male pattern hair loss.
• The issue of suicidal thoughts and behaviours was first assessed in 2012 further to reports of depression and suicidality potentially linked with finasteride use. That safety review could not determine a link between finasteride and suicidality due to the limited information available. At that time, it was decided that Health Canada would carry out a re-assessment of the potential safety issue after 2 years.
• In this follow-up review, Health Canada examined new data, however evidence available for assessment was still considered to be too limited to determine whether or not a link between finasteride use and suicidality exists. Health Canada therefore continues to monitor this issue and encourages healthcare professionals to report any side-effects suspected of being linked to finasteride use.

Overview

This safety review was carried out as a follow-up assessment on the potential risk of suicidality with the use of finasteride. The issue was first identified through Health Canada's routine monitoring activities but there was not enough information to draw a conclusion about the potential risk.

Use in Canada

• Finasteride (5 mg) is used to treat and control benign prostatic hyperplasia. It can also be used at a lower dose (1 mg) to treat male pattern hair loss.
• There are currently 2 brand name finasteride products sold in Canada: PROSCAR (5 mg) and PROPECIA (1 mg). There are also some generic finasteride products sold in Canada.
• Proscar has been sold in Canada since 1992, and Propecia since 1998.

Safety Review Findings

• From 1992 to the time of this review, Health Canada received 11 reports of suicidality that were suspected of being linked to the use of finasteride in Canada. Of these, 6 cases describe factors which appeared to be related to finasteride use, but 4 cases could not be assessed due to the limited information provided. One case was considered as unlikely related to finasteride use. Following the completion of this safety review, Health Canada received an additional report of suicidality with finasteride use. This case was assessed and it was determined that it may have been related to finasteride use.
• The World Health Organization's database contained 170 reports of suicidal thoughts and 56 reports of completed suicide with the use of finasteride at the time of the review. However, the data was not robust enough to definitively conclude on the strength of the link between finasteride and suicidality.
• Some literature reports have described a potential link between finasteride and suicidality, including studies describing side-effects such as depression, even when the patient stopped using finasteride. However, these few studies involving a small number of patients had limitations that could not confirm nor exclude a link between finasteride and suicidality.

Conclusions and Actions

• Health Canada's safety review concluded that the evidence was too limited to determine whether or not a link between finasteride and suicidality exists.
• Currently, the prescribing information for finasteride lists depression as a side-effect. Although it does not specifically list the risk of suicidality, it does advise patients to talk to their doctor or pharmacist promptly if they experience any known or unexpected symptoms.
• Health Canada will publish a Health Product InfoWatch article on finasteride and suicidality to inform Canadians about this safety review, and to encourage healthcare professionals to report any side-effects suspected of being linked with finasteride.
• Health Canada continues to monitor side effect 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 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 known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.