2023 – mid-year update

Drug regulators in France and Canada announced new warnings. A popular podcast discussed post-finasteride syndrome, while influencers urged followers to avoid finasteride.
Regulation

In January, Health Canada published a safety review (archived) which found a “possible link between the use of finasteride and the risks of suicidal ideation and self-injury.” The agency plans to update product safety information and notify health professionals of the changes.

In March, the Daily Mail reported that the UK Medicines and Healthcare Products Agency (MHRA) will launch a safety review of finasteride.

In May, French regulator ANSM announced the most significant regulatory change for finasteride in over a decade, in any country. Starting in April, red boxed warnings began to appear on packaging of the 1 mg dose taken for hair loss. The warning states, in part: “ATTENTION: This medication can lead to undesirable sexual and/or psychiatric effects.” It includes a QR code linking to an information packet which describes long-term effects: “Side effects may persist after stopping treatment and in some cases for an indefinite period of time.” These changes reflect long efforts by French advocacy group AVFIN to alert ANSM to the drug’s risks.

Packaging of finasteride (1 mg) in France after a regulatory change ordered by ANSM, the national regulator. Starting this year, all boxes must include a red boxed warning with a QR code linking to an information packet.

Also in April, Organon, the current marketer of Propecia, took the drug off the market in France. Finasteride (1 mg) remains available in generic form.

In June the U.S. Food and Drug Administration held a Patient Listening Session on post-finasteride syndrome. The agency describes these sessions as “cross-center meetings that allow the patient community to share their experiences directly with the FDA. During these sessions, patients, caregivers, and their advocates can share their experience with a disease or condition by talking directly with the FDA staff.” In the future, a summary may be published on the Patient Listening Session page under ‘Patient-Led Listening Session Summaries.’

See also: Regulators are waking from their slumber

Media & social media

In March, the Daily Mail broke the news that the UK’s drugs regulator was to launch an inquiry into the safety of finasteride: ‘Watchdog launches investigation into hair loss pill as men report huge rise in side effects including depression, low libido and erectile dysfunction.’ On the same day, the Medical Minefield podcast, part of the newspaper’s digital arm, aired an episode called ‘Just how safe is the hair-loss drug taken by millions of men?

In April, the Huberman Lab Podcast aired an episode called ‘The Science of Healthy Hair, Hair Loss and How to Regrow Hair.’ It included a 5-minute segment on post-finasteride syndrome. While Dr. Huberman was tentative about the status of the syndrome, he made an often-overlooked point about the changing role of dihydrotestosterone (DHT) across the lifespan.

Several men’s fitness influencers, with hundreds of thousands of followers collectively, sounded alarms about the risks of finasteride. The page also includes Joe Rogan describing his negative experiences with finasteride in a 2019 episode of his show, The Joe Rogan Experience.

Research

On the research front, there have been 22 papers published so far this year addressing risks and harms of 5-alpha reductase inhibitors (the drug class to which finasteride, dutasteride and saw palmetto belong). As usual, articles have come from the fields of urology, dermatology, pharmacovigilance and epidemiology. There were also five articles on cancer risk, one on legal matters and another on the burgeoning telehealth sector. Da Silva and de Souza, urology researchers in Brazil, published a study of the effects of dutasteride and tamsulosin on penile morphology. It has been added to a review of studies showing alterations of penile tissue linked to treatment with 5-alpha reductase inhibitors.

Finasteride Watch website

More compilations of firsthand experiences were added. One compiles user reviews from Drugs.com and Ask a Patient; another gathers reports of men who used the natural 5-ARI inhibitors saw palmetto or stinging nettle.

The lost men’ reviews adverse events in clinical trials which foreshadowed current concerns about long-term harms of finasteride and dutasteride. Another post reveals that finasteride is much more disruptive of hormone signaling than commonly understood.

A bibliography of research on birth abnormalities associated with 5-ARIs was added.

A new special section called ‘The Partnership’ documents how physician-researchers supported the launch and marketing of Propecia and Avodart as ‘key opinion leaders’ (KOLs). In exchange for promoting the drug, they received benefits such as research grants to their institutions, roles in clinical trials, and co-authorship of articles with Merck and GSK researchers. Some also signed on as consultants and speakers. (More recently, some of the KOLs cast doubt on post-finasteride syndrome: see Fertig et al, 2016 and the work of Kevin McVary, MD.)

This year, the post on penile alterations linked to 5-ARI treatment has been the most popular page other than the home page.

Coming soon: an in-depth critique of papers by a dermatologist who has been a strident skeptic of post-finasteride syndrome.

See also: 2023 – year in review