U.S. and European health regulators are warning the public of possible health risks linked to finasteride, a popular hair-loss drug.
The European Medicines Agency issued an alert on Thursday, stating it had confirmed suicidal thoughts as a side effect of finasteride tablets. The European regulator announced it would be implementing new measures to warn and protect the public.
This comes following an alert issued by U.S. health regulators in late April, which warned against the possibility of sexual dysfunction and depression linked to topical finasteride — a newer version of the medication that’s applied directly to the skin.
“There is no FDA-approved topical formulation of finasteride,” the agency said in the alert, adding that the safety, effectiveness, or quality of these products has not been evaluated.
“There are potential serious risks associated with the use of compounded topical finasteride products.”
While topical finasteride is also increasingly popular in Canada, a Health Canada spokesperson confirmed last week it was never approved here either.
The pill version of the hair loss drug, also sold under the brand name Propecia, is associated with the same rare but serious side effects. It is approved by the U.S. Food and Drug Administration (FDA) and Health Canada and has been on the market for the past 30 years.
In recent years, however, topical finasteride has been popularized by a number of new telemedicine websites focused on men’s health. These gels or lotions are often marketed as having fewer side effects than oral finasteride.
Rare but debilitating side effects
In February, Radio-Canada investigative program Enquête published an investigation into the drug, which featured the testimonies of 25 men who said oral or topical finasteride had caused devastating side effects.
The symptoms mentioned in the FDA’s statement echo the ones these men described to journalists. The agency says it has identified 32 cases of adverse reactions linked to topical finasteride over the past five years, with symptoms including anxiety, brain fog, depression, suicidal thoughts, insomnia, decreased libido, erectile dysfunction, and testicular pain.
Wei Wong, a Montreal man who was prescribed topical finasteride in 2023, said that after 10 days of using the hair loss serum, he developed debilitating side effects that continue to afflict him.
Wong claimed he was not told the product was not approved by Health canada, and said he chose the topical finasteride because his research suggested it caused fewer side effects than the finasteride tablets.
Many of the men interviewed by Radio-Canada were also under this impression: some claim that when they began experiencing side effects of oral finasteride, their doctors advised they switch to the ‘gentler’ topical version.
Wong believes this new FDA warning will help reduce the number of men who experience finasteride’s sometimes debilitating side effects.
“I am, however, perplexed at the paradoxical framing; the warning cites persistent side effects from topical finasteride, explains that topical finasteride is expected to enter the bloodstream as oral finasteride does, acknowledges the side effects reported are identical to those of oral finasteride, and somehow concludes that oral finasteride is FDA approved and therefore safe,” Wong wrote in an email.
Illegal marketing of topical finasteride in Canada
Canadian regulatory authorities confirm that selling unapproved health products is illegal. However, in Canada, topical finasteride is considered a compounded preparation, a medication custom-made by a pharmacist at the request of a doctor.
While this practice is permitted for individual use, Canada’s Food and Drugs Act prohibits the mass production and advertising of compounded drugs.
Despite these restrictions, many Canadian websites openly promote topical finasteride, showcasing sleekly branded bottles on their websites and social media posts.
These advertisements are problematic, says Jean-François Desgagné, president of the Quebec Order of Pharmacists.
Earlier this year, Enquête reporters tested three telemedicine platforms, obtaining oral finasteride prescriptions from Essential Clinic, Jack, and Rocky. This experiment concluded that the medical consultations offered by these sites were rushed and superficial, with healthcare professionals providing very limited information about the risks associated with the medication.
Neither Rocky nor Jack responded to our emails regarding the new FDA warning and Health Canada’s comments.
Essential Clinic co-founder Hisham Al-Shurafa said he has been selling topical finasteride since 2021. He noted that the product information pamphlet clearly states it is not approved by Health Canada.
However, clients navigating the site to obtain this medication are not obliged to consult this document. The lack of Health Canada approval does not appear to be mentioned anywhere else on the Essential Clinic website, or in its advertisements for topical finasteride.
Health Canada officials say that since January 2024, they have received five complaints concerning the sale and advertising of finasteride-based products on various websites.
“In two cases, Health Canada sent regulatory letters to the responsible companies, informing them of non-compliance and asking them to cease their activities. Two cases are still under review by the department, and one case revealed no non-compliance.”
The agency did not specify which companies were targeted.
