Overview • US FDA • Health Canada • European Medicines Agency (EMA) • France • Germany • Sweden • United Kingdom • Australia • Japan • Korea • Document library • Posts
Summary Safety Review – Finasteride – Assessing the Potential Risks of Suicide, Suicidal Thoughts (Suicidal Ideation) and Self-injury – 19 Jan 2023
From Key Messages, with emphasis added:
Health Canada’s review…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.
Health Product InfoWatch – March 2019
This safety review evaluated the risk of suicidal ideation associated with Proscar and Propecia (finasteride). Health Canada’s review concluded that there may be a link. Health Canada has notified the manufacturer to update the Canadian product monographs on this potential safety issue.
Summary Safety Review – Finasteride – Assessing the Potential Risk of Serious Muscle-Related Side Effects – 22 Jun 2017
Health Product InfoWatch – June 2018: Product monograph update: Proscar and Propecia (finasteride)
Summary Safety Review – Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) – Assessing the Potential Risk of Seizures – 5 Aug 2016
Summary Safety Review – Finasteride – Assessing the Potential Risk of Suicidal Thoughts and Behaviour (Suicidality) – 17 Dec 2015
Health Product InfoWatch – December 2015: Finasteride and suicidality