La advertencia marca la primera carta «Estimado Doctor» de una autoridad reguladora a raíz de las recientes medidas de seguridad de la finasterida de la FDA y la EMA.
16 de agosto de 2025
Estimados amigos:
El 7 de agosto, el Ministerio de Salud de Israel emitió una advertencia de seguridad (en inglés) a los proveedores de atención médica de todo el país sobre el potencial de ideación suicida entre los pacientes que toman finasterida.
Pharmacovigilent mitzvah
Einat Gorelik, MD, director of MOH’s Risk Management and Drug Information Department, noted at the top of his 1,700-word dispatch that it was prompted by recent actions from the US Food and Drug Administration (FDA), and European Medicines Agency (EMA), namely:
▪ April 22: The FDA alerted consumers, health providers and compounders that “There are potential serious risks associated with the use of compounded topical finasteride products,” none of which are FDA-approved. That, based on 32 cases involving symptoms common to PFS reported to the agency’s Adverse Event Reporting System between 2019 and 2024, including erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain. Most of those 32 cases involved side effects that “continued to persist after product discontinuation.”
▪ May 8: The EMA released the results of its investigation into reported links between use of 5-alpha reductase inhibitors (5-ARIs) finasteride and dutasteride, and suicidality, concluding that the drugs “can cause depressed mood, depression or suicidal thoughts. In some patients taking 1 mg finasteride tablets, problems with sexual function…may contribute to mood changes, including suicidal thoughts.” In all, the probe turned up 313 cases of suicidal ideation probably or possibly stemming from finasteride use, and 13 probably or possibly from dutasteride use. The EMA nonetheless opted not to remove the drugs from the market, stating that “the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses.”
In addition to the FDA and EMA’s findings, Dr. Gorelik based his warning, commonly known as a “Dear Doctor” letter, on (a) an original review of observational studies examining the incidence of depression and suicidality among finasteride patients, and (b) an analysis of reports of depression and suicidality among finasteride patients, within the MOH’s own database.
Epidemiological mavens
In his review of medical literature, Dr. Gorelik cites nine studies, published over the past decade. The most recent of them arrived just five months ago, in The Journal of Cosmetic Dermatology.
Titled Finasteride Use: Evaluation of Depression and Suicide Risk, the epidemiological research sought “to evaluate the association of depression and suicide with oral finasteride in males, using data from the [FDA’s] Adverse Event Reporting System (FAERS).”
“In this study, we investigated whether reporting in FAERS database could detect a signal…for [adverse events] as per 5 MedDRA preferred terms, namely, ‘completed suicide,’ ‘depression suicidal,’ ‘suicidal behavior,’ ‘suicidal ideation’ and ‘suicide attempt,’” writes lead researcher, Mesbah Talukder, a pharmacology professor at BRAC University in Dhaka, Bangladesh.
Notably, Prof. Talukder and his team of three fellow researchers divide those neuropsychiatric AEs into three chronological periods:
1. Pre-PFS era: 2006–2011
2. First post-PFS era: 2013–2018
3. Second post-PFS era: 2019–2023
The researchers—who «found no significant correlation between oral finasteride and depression/suicide reports from 2006 to 2011 but noted a significant number of such reports in 2013–2018 and 2019–2023″—point to three factors that potentially explain the latter two jumps:
▪ In 2012, the US FDA updated the finasteride package insert to include information on the so-called PFS;
▪ An article on persistent sexual dysfunction and depressive symptoms associated with oral finasteride [MS Irwig, Depressive Symptoms and Suicidal Thoughts Among Former Users of Finasteride With Persistent Sexual Side Effects, Journal of Clinical Psychiatry, 2012] gained significant media attention around that time; and
▪ In July 2012, the PFS Foundation was established to support research on so-called PFS.
Results of Prof. Talukder’s study, as with many pharmacovigilance studies, are presented in terms of reporting odds ratio scores (RORs), which compare the odds of an AE being reported for a particular pharmaceutical product to the odds of that same event being reported for other pharmaceutical products.
An ROR greater than (>) 1.0 indicates a higher-than-average reporting rate for the respective AE/drug combination. And while there’s no universally agreed-upon benchmark for what constitutes a safety signal—i.e., data that warrants further investigation and, arguably, disclosure via public-health communication channels—many pharmacovigilance sources put that benchmark at ≥ 2.0.
In his finasteride study, Prof. Talukder reports the data for suicidal behavior as follows:
▪ In the pre-PFS era…there was no signal for suicidal behavior for any dose of finasteride.
▪ A signal was detected for this AE only in the 2nd post-PFS era; furthermore, a signal was detected for any dose (ROR = 3.23) and 1 mg (ROR = 6.63) of oral finasteride.
And the data for suicidal ideation is reported as follows:
▪ In the pre-PFS era…there was no signal for suicidal ideation for any dose of oral finasteride.
▪ Across the 1st post-PFS era…a signal was detected for suicidal ideation with oral finasteride of any dose (ROR = 2.83), 1 mg (ROR = 3.63), and 5 mg (ROR = 1.85).
▪ Likewise, in the 2nd post-PFS era…a signal was detected with the use of oral finasteride at any dose (ROR = 4.96), 1 mg (ROR = 9.90) and 5 mg (ROR = 2.37).
Otherwise put, that ROR of 9.90 means men taking finasteride 1 mg are nearly 10 times more likely to suffer from suicidal ideation than are men taking other prescription medications.
Be well
In his analysis of AEs from the MOH database, Dr. Gorelik writes:
The Risk Management Department received several reports of suicidal thoughts and depression for finasteride products. Several reports were received via letters from pharmaceutical companies authorized to market finasteride, and individual reports were received from the public… All reports were for products intended for the treatment of androgenetic alopecia, and the average age was 35 years. Approximately 50% of the reports of depression and suicidal thoughts/behavior included reports of sexual dysfunction.
Dr. Gorelik also notes that, similar to the US, there are no MOH-approved topical-finasteride products in Israel, only unapproved compounded products.
Three pharmaceutical companies currently hold marketing authorization for finasteride in Israel: Organon, Teva Pharmaceuticals, and Bioavenir; and six for dutasteride: GlaxoSmithKline, Unipharm, Teva, Inovamed, KS Kim, and Taro.
In terms of MOH’s recommendations for reducing the risks of depression and suicidal ideation during 5-ARI therapy, Dr. Gorelik tells health providers:
• When prescribing finasteride products, patients should be informed of the possible side effects and instructed to discontinue treatment and seek medical help in cases where mood changes, depression, or suicidal thoughts appear.
• Patients should be informed to seek medical advice if they experience impaired sexual function, for fear of the impact of these side effects on mood, and to consider discontinuing treatment.
• A risk-management plan will be implemented for oral finasteride prescribed for the treatment of androgenic alopecia, which will include a patient information card.
The MOH’s warning marks the first Dear Doctor letter sent by a drug-regulatory authority (DRA) in the wake of the FDA’s alert on topical finasteride, and the EMA’s investigation into causative links between 5-ARIs and suicidality. Ditto the introduction of a patient information card in any nation outside of Europe.
“We applaud this move by Israel to proactively make its citizens aware of the many potential dangers to physical, mental, and sexual health posed by a medication used chiefly for cosmetic purposes,” says PFS Foundation President Philip Recchia.
“Moreover, we recommend that drug-regulatory authorities in every nation where finasteride has been granted marketing authorization issue their own Dear Doctor letters in the near future.”
(For a complete list of all known regulatory actions surrounding finasteride safety, see our PFS Global Warning Map.)
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.