Regulatory Update: Canada Concludes ‘There May Be a Link Between Finasteride and Risk of Suicidal Ideation’

February 29, 2019

Dear Friends:

Could Canada be thawing to the notion of a finasteride-free nation?

Earlier this week, our neighbor to the north announced that Propecia and Proscar patients may be at risk for considering and attempting suicide, and mandated that the manufacturer update its product insert to reflect this potential danger.

The move by FDA-equivalent agency Health Canada (HC) comes just eight months after warning that “Rare cases of muscle-related disorders…have been reported in patients treated with finasteride.” What’s more, “In some cases, these disorders were found to be reversible with discontinuation of finasteride therapy.” (It seems safe to assume that if "some" reported cases returned to normal after quitting finasteride, other cases were persistent, and may possibly be permanent.)

HC’s latest finasteride action also comes just 25 days after French FDA-equivalent agency ANSM issued a letter to 100,000 health professionals reminding them that patients treated with finasteride are at risk for developing psychiatric disorders and persistent sexual disorders. (English translation here .)

On Feb. 26, HC issued a Summary Safety Review titled Proscar and Propecia (finasteride): Assessing the potential risk of suicidal thoughts and/or behavior (suicidal ideation), in which it notes:

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 agency also states that “Between 2012 and 2016, the Canadian reporting rate for finasteride and suicide/self-injury-related events increased by 2.5 times.”
HC then concludes that “there may be a link between Proscar and Propecia (finasteride) and the risk of suicidal ideation,” before announcing that it has “notified the manufacturer to update the Canadian product information to include a warning on this potential safety issue.”
 
We once again thank Health Minister Ginette Petitpas Taylor for ensuring that Health Canada is taking proper action in response to adverse drug reaction reports filed by Canadian PFS patients.

Anyone living in the US who suffers from PFS should report his symptoms to the US Food and Drug Administration; anyone living outside the US who suffers from PFS should report his symptoms to the US Food and Drug Administration as well as to his national drug-regulatory agency, as directed on our Report Your Side Effects page.

If you or a loved one are suffering from PFS, and feeling depressed or unstable, please review our Frequently Asked Questions page as soon as possible. After that, don’t hesitate to contact the PFS Foundation via our Patient Support hotline: social@pfsfoundation.org

Thank you.

Related News

PFS is Front-page News in the Netherlands (Feb. 25, 2019)

Regulatory Update: France’s FDA-Equivalent Agency Reissues Finasteride Warning (Feb. 2, 2019)

French Urologist to Top TV News Mag: Propecia is a potentially dangerous drug—’I even told my brother-in-law to stop taking it’ (Feb. 10, 2019)

France’s Le Monde to 300,000 Readers: Finasteride Users Beware (Feb. 1, 2019)

Regulatory Update: ‘Muscle-related Disorders’ Added to Canadian Finasteride Label in Response to Report by FDA-equivalent Agency (July 28, 2018)

Regulatory Update: Germany’s FDA Equivalent Issues ‘Red Hand Letter’ on Finasteride ADRs (July 6, 2018)

French Warning of Propecia-Induced Depression and Suicidal Ideation Prompts Wave of Media Attention (Dec. 19, 2017)

Regulatory Update: Korea Mandates Propecia Label Change Based on Reports of Depression and Suicidal Ideation (July 15, 2017)

Regulatory Update: European Medicines Agency Recommends Adding Depression and Suicidal Ideation to Finasteride Label (April 10, 2017)