Patient-alert card and ‘Dear Doctor’ letter will be rolled out in effort to minimize risk of this frequently-debilitating, sometimes-fatal ADR
May 11, 2025
Dear Friends:
From Sweden to Spain—and in 25 nations along the way—thinking about killing yourself is now an official side effect of finasteride.
On Thursday, the European Medicinces Agency (EMA) released the results of its probe into the causal relationship between 5-alpha reductase inhibitors (5-ARIs) and suicidality.
Dangerous ideation
“Finasteride tablets can cause depressed mood, depression or suicidal thoughts,” the EMA wrote. “In some patients taking 1 mg finasteride tablets, problems with sexual function…may contribute to mood changes, including suicidal thoughts.”
The five-month procedure, directed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) and encompassing all 27 nations within the European Union (EU), reviewed available information on this growing public-health concern while weighing its impact on the benefit-risk balance of both finasteride and fellow 5-ARI dutasteride.
Sources included studies and case reports published in scientific literature; epidemiological data from EudraVigilance; results from clinical trials; and anecdotal evidence from patients or their relatives, healthcare providers, researchers, and patient advocacy groups.
In all, the PRAC turned up 313 cases of suidical ideation probably or possibly stemming from finasteride use, and 13 probably or possibly from dutasteride use. The majority of those cases involved patients taking finasteride 1 mg, prescribed for hair loss. How frequently finasteride patients in the EU suffer from suicidal ideation is, however, impossible to estimate from the available data, the EMA noted.
The agency opted not to suspend or remove 5-ARIs from the market, having concluded that “the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses,” adding that “A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines.”
All wet across the pond?
Nestled among the EMA’s findings is also one data point that might seem perplexing to anyone with even tepid interest in the epidemiology of PFS, which is this:
“The review found no evidence linking suicidal ideation to finasteride skin sprays and no new information is being included in the product information for these sprays.”
Yet in a safety alert issued just 19 days ago, the US Food and Drug Administration (FDA) wrote: “There are potential serious risks associated with the use of compounded topical finasteride products.”
That, based on 32 cases involving adverse drug reactions (ADRs) reported to the agency between 2019 and 2024. Among them are: erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain.
Most of those 32 cases, the FDA noted, involve side effects that “continued to persist after product discontinuation,” which is of course a textbook definition of PFS.
28.35 grams of prevention
The EMA will nonetheless undertake efforts to help “minimize the risk of suicidal thoughts with finasteride and dutasteride medicines.” They include:
▪ Adding a patient card in the packages of all finasteride 1 mg products to let consumers know that the drug can cause depressed mood, depression or suicidal thoughts.
▪ Supplementing the finasteride product label with instructions to seek medical advice if patients experience problems with sexual function (such as decreased libido or ED), which are known side effects that may contribute to mood changes.
▪ Dispatching a direct health care professional communication (aka “Dear Doctor” letter) to relevant providers, and publishing it on a dedicated page on the EMA website.
Dissenting opinion
In the results of its suicidality probe, the EMA wrote that health care professionals should “advise patients using 1 mg oral finasteride for androgenetic alopecia to stop treatment and seek medical advice if they experience depressed mood, depression or suicidal ideation.”
“The problem with such advice is that it implies a happy ending for any finasteride patient who suffers from any number of commonly reported side effects. Toss your pills in the trash, talk to your friendly neighborhood doctor and—voila!—troubles gone,” said PFS Foundation President Philip Recchia.
“But after interacting with more than 3,300 PFS patients over the past 13 years, including 25 suicide cases, trust us when we tell you that these adverse events more often than not persist indefinitely.
“And since there are no scientifically proven therapies for PFS, doctors are severely limited in how they can help, assuming they can help at all. In fact, it’s not uncommon for doctors to contact us asking for help.
“So it’s incumbent on all health providers and pharmacists to advise against ever taking finasteride in the first place. Because at the moment, that’s the only way to ensure they do no harm.”
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).
In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”
Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.
Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, 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 don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
Thank you.