一位“误打误撞”的调查员的笔记

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2026年8月14日

亲爱的朋友们：

If you’d told me in 2001, when I first learned of the drug, that I’d ever mention Propecia and serial killers in the same breath, I’d have dismissed you as delusional. And yet, a quarter century on, I can’t think of a better metaphor for the investigative challenges I now face each day.

To understand how I’ve come to this—how seemingly isolated deaths can ultimately be connected as manifestations of the same underlying public-health crisis—consider the case of one of history’s most notorious serial killers: Ted Bundy.

Connecting the Chalk Outlines

In October 2012, Dr. Santmann filed an Individual Case Safety Report with the U.S. Food and Drug Administration (FDA), noting that Randy “was suffering from what is now known as post-finasteride syndrome.” He also quoted from the diary his son kept while a psychiatric in-patient. It read, in part, “I feel completely dead and emotionless inside… Finasteride has permanently turned me into a different person.”

When Randy took Propecia, none of his adverse reactions appeared on the product label, nor did it warn that any could persist post-treatment.

In December 2006, however, the Swedish Medical Products Agency (SMPA) published an analysis titled “Does Propecia Impair Sexual Function after Treatment?” In it, regulators noted: “Prior to the approval of Propecia, there were no data, either from animal studies or from clinical trials, in men with hair loss to suggest any persistent problems.”

Swedish regulators also instructed Propecia manufacturer Merck & Co. to provide every adverse drug reaction report involving sexual function in men who had taken the medication, including those in which symptoms persisted after quitting. Nearly two years later, during the same month Randy died, SMPA required Merck to add a warning that erectile dysfunction could persist after discontinuation, marking the world’s first regulatory warning that finasteride-related sexual dysfunction could continue post-treatment.

Yet doctors and patients outside Sweden remained largely unaware that this increasingly popular hair-loss drug could be associated with long-term sexual dysfunction.

Regulators reported adverse reactions into the WHO’s adverse-event database (VigiBase), but most still maintained separate national pharmacovigilance systems. No regulator had timely visibility into every finasteride report being submitted worldwide, including reports of death.

But Merck had access to something no individual regulator possessed: its own consolidated global adverse-event database—the reports flowing to the company from every market in which it sold finasteride.

I wouldn’t learn the extent of the company’s knowledge until 2021.

The Gallery of Tragedies

Meanwhile, another pattern was quietly emerging. During the foundation’s early years, reports of suicides among men suffering from what appeared to be PFS began arriving with unsettling regularity. So I pinned photographs of each victim to a bulletin board, arranging them chronologically as new cases came in.

What began as a handful of individual reports gradually became something that looked less like a collection of tragedies and more like a dataset. I never imagined that elsewhere in the world, a substantially larger record of adverse events—including deaths—had been accumulating for more than a decade in regulatory databases.

These were among the 30 deaths reported to me:

2012

Jan. 28: Patrick Ortiz, 24, of Bakersfield, California, dies from a prescription opioid overdose.

2013

March 5: John Pfaff, 40, of Encinitas, California, dies by suicide after being struck by a speeding train.

2014

April 12: Daniel Stewart, 37, of Denton, Texas, dies by suicide after hanging himself.

Sept. 8: Steve Kenney, 42, of Doraville, Georgia, dies by suicide after hanging himself.

2015

Nov. 4: Paul Dixon, 31, of Newcastle upon Tyne, England, dies by suicide after hanging himself.

2016

Jan. 20: Eric Rodriguez, 33, of Stevenson Ranch, California, dies by firearm suicide.

June 7: Romain Mathieu, 25, of Morainvilliers, France, dies by suicide from acute carbon monoxide poisoning.

Upon confirming each suicide, I informed Dr. Santmann via text. In July 2016, after Romain’s death showed up on his phone, he decided to file an FDA Citizen Petition. The foundation would make a case for taking finasteride off the market, or at least adding a black box to the drug—the FDA’s most serious warning, reserved for risks that can be life-threatening.

Britain Breaks the Silence

In May 2017, four months before we filed our Citizen Petition, Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) added psychiatric warnings to the finasteride insert, noting that the drug “has been associated with depression and, less frequently, suicidal thoughts.”

That appears to have been the first national regulatory warning linking finasteride to suicidal ideation. But the only country to follow suit soon after was South Korea. In July 2017, its Ministry of Food and Drug Safety (MFDS) warned: “Mood swings including depressed mood, depression and suicidal thoughts were reported by patients treated with 1 mg of finasteride.”

Yet again, doctors and patients outside those two nations remained largely unaware of reports linking finasteride to suicidality. To understand how the FDA eventually came to acknowledge that emerging signal, we need to step back six years.

In early 2011, plaintiffs sued Merck alleging that Propecia caused persistent sexual dysfunction after discontinuation and that the company failed to provide adequate warnings. By year’s end, roughly 100 men had filed approximately 60 lawsuits in U.S. courts.

By 2018, roughly 600 plaintiffs had joined the litigation. In April of that year, Merck settled the multidistrict litigation for $4.3 million without admitting liability. And in its quarterly report to the U.S. Securities and Exchange Commission (SEC), Merck disclosed the settlement in a litigation footnote, without identifying it as a material event.

Following the settlement, coverage was limited to legal trade publications, all of which are subscription only. It would take 17 months before the story reached the mainstream press.

On Sept. 11, 2019, Reuters published an investigative report, headlined Court Let Merck Hide Secrets About a Popular Drug’s Risks, that exposed previously sealed testimony by former Merck executives in the Propecia litigation suggesting that the company downplayed the drug’s side effects during clinical trials.

A day after the newswire’s exclusive was delivered to major media outlets worldwide, Reuters filed a motion in federal court to unseal documents filed in the mass tort revealing potential risks associated with the drug.

Invisible Pharmacovigilance Illuminated

Sixteen months later, on Jan. 25, 2021, U.S. Magistrate Judge Peggy Kuo approved Reuters’ motion, clearing the way to make documents in the Propecia litigation public. In her decision, she noted that Merck’s arguments for keeping those documents under wraps “are so weak that they would not overcome even a low presumption of access under the common law.”

That allowed Reuters to publish information it had previously been able to use only on background. On Feb. 3, 2021, the newswire ran a follow-up report headlined Merck Anti-baldness Drug Propecia Has Long Trail of Suicide Reports. For the first time, the public could see evidence of what U.S. regulators and the company that developed and marketed Propecia had known for years.

The newly unsealed court documents showed Merck and FDA officials were aware of reports of suicidal behavior among Propecia users when they decided not to add a suicide warning during a 2011 label update. After that decision, the FDA received more than 700 reports of suicide and suicidal thoughts associated with Propecia, including at least 100 deaths. During the drug’s first 14 years on the market the agency had received 34 such reports, including 10 deaths.

By then, I decided to go public in my role with the foundation, assuming the title of president. One of my first acts in that capacity was to publish the documents Judge Kuo had ordered unsealed. All 11, along with 13 others released voluntarily by Merck, are housed in the Propecia Litigation Library section of our website.  

Also in 2021, Merck underwent major corporate changes. A day after Reuters ran its report on the newly unsealed documents, the company announced that CEO Kenneth C. Frazier would retire. Merck then completed its spin-off of Organon—which took Propecia with it—while naming Merck’s President of Global Enterprise Portfolio Strategy, Kevin Ali, as CEO of the new “global women’s health company.”

Out from Under the Rug

By the summer of 2021, nearly three years had passed since we filed our Citizen Petition. So we did what any tiny, underfunded nonprofit would do: we dragged the world’s most powerful drug regulator into court.

In September we filed a lawsuit claiming that, considering the nature and extent of the public health interests raised in the petition, the FDA had unlawfully withheld or unreasonably delayed taking any of the actions we’d requested.

We prevailed, and on June 8, 2022, the agency wrote us: “[W]e are requiring that Organon make labeling changes…to clarify the risks of use of Propecia. We are requiring the addition of suicidal ideation and behavior to the list of nervous system/psychiatric reactions.”

In August 2022, Organon implemented those changes—but only in the Prescribing Information (package insert), a complex document, running 7,154 words, that’s written in scientific terms for doctors and pharmacists. The Patient Product Information, a 947-word document written in lay terms, wasn’t updated in tandem with the Prescribing Information. That wouldn’t happen for another 15 months, after the foundation published its own report on the amended product label.

Compounding this problem, the FDA didn’t mandate that Organon distribute a Dear Health Care Provider Letter to alert physicians and other health care providers about important safety concerns that physicians could communicate to their patients.

The Gallery Expands

In the years following Organon’s label update, reports of fatalities among men suffering from what appeared to be PFS began arriving more frequently. Those cases include:

2021

Nov. 2: Carter Friedrich, 26, of Fairfield, California, dies by firearm suicide.

2023

May 23: Andrew Hvatum, 37, of St. Louis, Missouri, dies by suicide after hanging himself.

June 19: Joseph Stanley, 29, of Jacksonville, Florida, dies by firearm suicide.

2024

Dec. 16: Kelsey Libner, 52, of New York, New York, dies by suicide from acute nitrate poisoning.

2025

Feb. 4: Carlos Sarasa González-Aller, 46, of Madrid, Spain, dies by suicide after jumping from an office building.

Feb. 23: Jalan Lotfolahpour, 26, of Frankfurt, Germany, dies from central regulatory failure due to intoxication.

A Question of Causation

Witnessing the media firestorm that ripped through Spain in the wake of Carlos’ death, it became impossible for me to ignore the pattern I’d begun tracing 13 years earlier. If, buried in our patient database, were more such incidents, I wanted to know. Looking back through it, I found four additional cases. Two offer stark illustrations of the pattern:

• Nathan Ficek of Sobieski, Minnesota, calls July 28, 2019, to report debilitating PFS symptoms, telling me, “I’ve accepted that I’ll have these side effects for the rest of my life.” On July 26, 2021, he dies unexpectedly of an undisclosed cause at age 40.

• Paul Rizzuto of Nashville, Tennessee, calls June 9, 2021, to report debilitating PFS symptoms, and asks to be connected with fellow PFS patients. A week later, on June 16, he dies unexpectedly of an undisclosed cause at age 38.

From Defense to Silence

In October 2024, the European Medicines Agency (EMA) began an EU-wide review into “the causal relationship between suicidal ideation and/or suicide and treatment with finasteride.” Six months later, the agency released its results, confirming suicidal ideation as a side effect of finasteride tablets, while concluding that the benefits of the medicine continued to outweigh the risks.

Organon didn’t immediately respond to Reuters’ request for comment following the EMA’s announcement. That was a stark contrast to previous Propecia controversies, when Merck was quick to defend its product, often suggesting that patients were wrong to hold the drug responsible for persistent adverse reactions of any kind. For years, the company’s response had been remarkably consistent: deny, minimize, or redirect the concern. Now, following the EMA’s finding, the response was conspicuously absent.

In December 2010, the BBC published a report headlined Baldness Drug Propecia ‘Risking Men’s Sexual Health’. In it, James Dunford, 26, of Edinburgh, Scotland (who, incidentally, would die unexpectedly of an undisclosed cause seven years later) recounted how he became “completely impotent” three weeks after starting Propecia, and failed to regain regular sexual function long after quitting.

Merck, the BBC noted, claimed “those cases are extremely rare and could be caused by something other than Propecia itself.”

Eighteen months later, in response to an interview with Dr. Santmann about Randy’s suicide, Merck told CBS News Philadelphia that once Propecia is stopped, the sexual dysfunction goes away.

In response to a report on Romain’s death, Merck told French newspaper Le Parisien (English) in 2019 that “health authorities consider the benefit-risk ratio of Propecia to be favorable” and that “the information concerning the cases of sexual disorders and depression are described accurately” in the prescribing information.

In 2022, Merck responded to a New York Post report on Steve’s death: “Merck continues to stand behind [Propecia’s] safety and efficacy when used according to the label.”

And only last year, three months prior to the EMA’s ruling, Organon responded to Carlos’ death by telling Spanish newspaper El Confidencial (English) “At no time has a causal relationship been established between the use of finasteride and suicidal ideation.”

More Pictures at the Deathly Exhibition

I wish I could come full circle with the serial-killer analogy by saying the danger had been contained. I can’t.

Finasteride remains on the market worldwide, prescribed to millions of men despite continuing concerns about serious psychiatric adverse effects.

As of August 1, 2026, VigiBase listed 135 reports coded as completed suicide associated with the drug; the FDA’s recently launched Adverse Event Monitoring System (AEMS), formerly FAERS, contained 287 reports coded as completed suicide. Neither figure establishes causation: these are spontaneous safety reports, not adjudicated determinations that finasteride caused the deaths.

For anyone still considering finasteride, consider this: Just 19 days before completing our annual address, I received an email (cc’d, incidentally, to Organon) with the subject line “Death by suicide.” It read, in full:

“Our 26-year-old son took his life on June 4 in Australia after being on this medication for five months. He had no mental health problems. This drug is extremely dangerous and should not be allowed to be sold. How many suicides does it take from this medication worldwide for someone’s death to count?”

I wish I could say emails like that are rare. They aren’t. The one above was the third such message I’d received in the previous 18 months—from Australia alone.

Fifteen years after I began connecting the chalk outlines, the investigation remains ongoing.

(If you have a loved one whose death you believe was linked to finasteride use, please email us at ColdCase@pfsfoundation.org.)

Now let’s get to the highlights of our regulatory, research, and awareness efforts from the past 12 months.

REGULATORY ACTIVITY

While we regularly applaud France and the U.K. for taking their finasteride pharmacovigilance to the next level, we’ve admittedly come to expect it in recent years. What we didn’t expect this year was a Middle Eastern nation to join the effort.

Israel Breaks Ranks

In August, the Israeli Ministry of Health (MOH) issued a safety warning (English) to health care providers nationwide about the potential for suicidal ideation among finasteride patients. 

Einat Gorelik, MD, director of the agency’s Risk Management and Drug Information Department, noted at the top of her Dear Doctor dispatch that it was prompted by the FDA’s April 2025 alert on topical finasteride, and the EMA’s May 2025 review of causative links between 5-alpha-reductase inhibitors (5-ARI) and suicidality.

Dr. Gorelik based her warning 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.

The MOH’s recommendations for reducing the risks of depression and suicidal ideation include a forthcoming patient information card, like those implemented in recent years by the MHRA and French drug regulator ANSM.

Doctor-Patient Contract

In February, ANSM imposed yet-stricter regulations (English) on finasteride, namely in the form of what it calls a shared-information certificate.

Beginning April 16, anyone taking finasteride 1 mg for the first time was required to sign—along with the prescribing doctor—a form that spells out the myriad risks the drug poses to human health, including:  

• Psychiatric disorders (depressed mood, depression, suicidal thoughts);

• Sexual dysfunction (including erectile dysfunction, ejaculation disorders, decreased libido);

• The possible persistence of certain effects after discontinuation of treatment.

Designed to help ensure that doctors thoroughly review with patients the possibility of life-altering adverse events arising from finasteride use, the certificate is valid for one year. After that, it must be renewed annually. And it must be presented by the patient to the pharmacist for each new prescription and refill.

Britain Raises the Bar

In May, the MHRA announced new measures to minimize the risk of suicidality among patients taking finasteride and fellow 5-ARI dutasteride. Those measures—which include a new warning on the finasteride 1 mg label that sexual dysfunction may contribute to mood disorders—were formulated after a three-month review of:

• Medical literature cited in the EMA’s May 2025 finasteride-safety probe.

• Actions taken by regulators in other nations, and

• Local pharmacovigilance (Yellow Card) data.

For the latter, the MHRA compiled all its reports of 5-ARI-related suicidality between 1994 and May 31, 2025, turning up:

• finasteride suicidal ideation: 170 cases

• finasteride suicides: 19 cases

• dutasteride suicidal ideation: 5 cases

• dutasteride suicides: 0 cases

RESEARCH

Ask 10,000 random Americans to describe Michigan in five words or less, and I bet not one would respond with “a hotbed of medical innovation.” Before the decade’s out, however, that may be how at least a handful come to see the Mitten State—if they’ve developed PFS.

An All-Star Team Assembled

Thanks to the vision and generosity of Kenneth M. Peters, MD, an international roster of clinicians and researchers investigating PFS, post-SSRI sexual dysfunction (PSSD), and post-Accutane syndrome (PAS) gathered this spring at Corewell Health William Beaumont University Hospital in Royal Oak, Michigan, for the First World Congress on Post-Drug Syndromes (PDS). Held April 23 through 25, the event sought to explore the possibilities and logistics of developing effective therapies for these often-devastating conditions.

The congress kicked off with advocacy groups for each syndrome, including the PFS Foundation, providing overviews of their work and discussing their missions. For the remainder of the event, clinicians and researchers from as far away as Finland and Australia lectured on their respective areas of expertise, which spanned urology, neurology, psychology, endocrinology, epidemiology, and epigenetics.

Among those lecturers were Mohit Khera, MD, of Baylor University, Irwin Goldstein, MD, of San Diego Sexual Medicine, David Healy, MD, of Data-Based Medicine, Antonei Csoka, PhD, of Howard University, and Alfonso Urbanucci, PhD, of Tampere University. The world’s two most prolific PFS researchers, Roberto Cosimo Melcangi, PhD, of the University of Milano, and Michael S. Irwig, MD, of Harvard Medical School, participated remotely via video conference.

Capping off the congress was a session on drafting a manuscript for The Journal of Sexual Medicine, which will include sections on the incidence and prevalence of PDS, diagnosing PDS, treating PDS, and research priorities for identifying potential therapies. If all goes well, the paper will be submitted for publication by year-end. 

For more on the PDS Congress and its long-term goals, see this interview with Dr. Peters, who’s Chair of Urology at Beaumont, by Robb Dixon of fellow patient-advocacy group SIDEfxHUB, who also presented at the event.

Indicted in the Court of Public Opinion

In September, Mayer Brezis, MD, publicly posed this question:

“Who is liable for waiting two decades to warn the public that finasteride can cause severe neuropsychiatric reactions, thus putting millions of patients at risk for suicide?”

His verdict? “The FDA could and should have requested disproportionality analyses, but it did not. The manufacturer [Merck] was aware of underreporting but dismissed the problem.”

That was the conclusion of his systematic review of post-marketing surveillance, which asked who was responsible for this epidemiological debacle.

Titled Failing Public Health Again? Analytical Review of Depression and Suicidality From Finasteride, his paper appeared in The Journal of Clinical Psychiatry, which has an impact factor of 5.3.

Notably, Dr. Brezis, who holds a Master of Public Health degree and serves as Professor of Medicine (Emeritus) at Hadassah Medical Center in Jerusalem, dedicated his research to the memory of a friend who died by suicide shortly after beginning, then quitting, finasteride for hair loss. He disclosed as well that he served as an expert witness on a recent trial involving a 49-year-old Israeli man who died by suicide in 2015 after taking Propecia, which prompted him to publish his evidence presented in the litigation.

A Different Pathway

And now, we once again applaud France for leading the PFS awareness charge worldwide. 

During the same month that Dr. Brezis published his review, the nation where at least 26,000 men take finasteride for hair loss challenge long-standing assumptions often used to question the mere existence of PFS.

Researchers at the Regional Pharmacovigilance Center in Limoges unveiled a study analyzing cases of depressive disorders among finasteride patients not also suffering from loss of libido or sexual dysfunction.

Titled Isolated Depressive Disorders and Suicidality with Finasteride Use for Androgenetic Alopecia: A Call for Enhanced Vigilance, the retrospective descriptive analysis was published Sept. 18 in Therapies, the official publication of the French Society of Pharmacology and Therapeutics.

In all, Marie-Laure Laroche, MD, and Hélène Géniaux, PharmD, turned up 40 such incidents, with a median age of 31, in France’s National Pharmacovigilance Database (BNPV). Forty percent of those cases included suicidality, while only 22.5% had any pre-finasteride history of anxiety, depression or suicidality.

“Contrary to hypotheses that depression might result from finasteride-induced sexual dysfunction, our findings support the possibility of a direct effect of finasteride on the brain,” wrote Dr. Laroche. “One proposed mechanism involves the disruption of neurosteroids such as dihydrotestosterone (DHT) and allopregnanolone, both known to exert [anxiety-reducing] and antidepressant effects.”

From Michigan to Milano

Published in the Journal of Neuroendocrinology, Finasteride Withdrawal Induces Anxiety-like Behavior and Novelty Avoidance in Adult Male Rats was the first known effort to investigate how behavioral effects following finasteride withdrawal might differ from those seen during treatment.

“[A]lthough finasteride has limited behavioral effects after chronic treatment, the drug suspension leads to persistent behavioral alterations characterized by increased locomotion, increased anxiety-like behavior, and marked avoidance of novel stimuli,” wrote coauthors Lucia Cioffi, PhD(c) and Silvia Diviccaro, PhD.

This latest research marked the completion of study No. 2 within the Milano Project. Launched April 2024 in partnership with the PFS Foundation and SIDEfxHUB, the project is comprised of seven preclinical studies designed to map the basic science of PFS and, in turn, identify potential therapies for this emerging epidemic.

(For a complete list of noteworthy PFS studies, see our Medical Literature page.)

MEDICAL AWARENESS

The Geneticist and the First Follicles

Clinicians, pharmacologists and researchers continue to voice their concerns about finasteride use, particularly in young men. Year over year, the number of such professionals aggregated on our Doctors & Researchers Speaking Out page broke 200 rising from 190 to 206.

Among the 32 new entrants is one of the distinguished lecturers at the First World Congress on PDS: Alfonso Urbanucci, PhD. In an October report in Danish life-sciences magazine MedWatch (Patient Organization in Sharp Criticism of the Danish Medicines Agency), the Project Group Leader at Oslo University Hospital’s Institute for Cancer Research said:

“Our research shows that a percentage of individuals are genetically predisposed to side effects, and we are working to understand the genetic disposition for those potential side effects.”

Seven months later, Robert Klitzman, MD, professor of psychiatry at Columbia University Irving Medical Center, weighed in on whether Donald Trump was still taking finasteride—as the president disclosed during his first term. Dr. Klitzman was the go-to guy in a Washington Post report headlined The Hair-loss Drug Trump Took for Years Is Now Absent from His Medical Records.

“Trump’s allies have mocked the persistent focus on the president’s health [but] Klitzman said the White House’s lack of transparency about Trump’s use of a hair-loss drug may reflect its unwillingness to be honest about the nearly 80-year-old president’s health,” wrote Dan Diamond. “[Klitzman] also noted that use of finasteride has been linked with an increased risk of depression, which could affect a president’s performance.”

EPIDEMIOLOGY

Suicide Spike

We continue to monitor and publish ADR data for finasteride housed on VigiBase. Year over year, reports coded as completed suicide rose 17.4%, suicidal ideation 17%, psychiatric disorders 12.6%, erectile dysfunction 9.5%, and suicide attempt 9.2%. 

From an aggregate perspective, the total number of finasteride ADRs rose 9.6%, to 27,866. The absolute number of 2,545 new ADRs during this period translates into nearly seven new finasteride adverse-event reports every day.

(For additional epidemiological data, see our PFS by the Numbers page.)

MEDIA AWARENESS

A Bull Market in Bulldog Reporting

Here in our news feed on March 6 we asked, Could Undercover Reporting Become the New Norm Among Media Working to Expose Illicit Access to Finasteride? The rhetorical question was prompted by investigative reports into finasteride safety by 10 major media outlets in eight nations over the previous 12 months. Three of those reports employed undercover tactics in aggressive efforts to protect public health:

• ROME (October 24, 2025) — Investigative news magazine FarWest airs an episode titled The Undisclosed Risks of a Hair-Loss Drug in which host Salvo Sottile exposes “the disarming ease” with which finasteride can be obtained in Italy. Working clandestinely, one of his reporters walks into five random pharmacies and asks for finasteride. In each case, he informs the pharmacist that he has no prescription, then asks if it would still be possible to buy the drug. Four of the five pharmacists say yes—and proceed to dispense the medication. “Selling a prescription drug without a prescription is a crime,” warns Sottile.

• TEL AVIV (October 25, 2025) — During the weeks leading up to attorney Jonathan Davies filing closing arguments in the Israeli Propecia litigation, investigative powerhouse Shomrim (think the ProPublica in Hebrew) teams up with i24 News to produce print and broadcast reports highlighting the growing body of evidence linking finasteride to suicidality. For her N12 Magazine report on the dangers of finasteride, Suicide, Serious Side Effects and Disclosures: What Do We Know About the Drugs We Take? (English), Yael Shani catches a doctor on tape telling a patient, vis-à-vis the drug’s depressive side effects, “I’ve been taking it for 30 years and nothing ever happened to me.”

• LONDON (January 20, 2026) — BBC Radio’s FileOn4 debuts an investigative report into whether U.K. finasteride hawkers are heeding the MHRA’s 2024 alert on the drug being linked to depression, suicidality and sexual dysfunction. Titled Thin on Information?, it enlists experts to weigh in on the ethics of transplant surgeons downplaying the drug’s risks, and the legality of influencers touting finasteride on social media. While posing as a hair-transplant patient, producer Rob Byrne is told by one clinic director, “studies…have proved there is no such thing as sexual dysfunction” arising from finasteride use.

Robbed of His Health, Dixon Sets the Airwaves Afire

Meanwhile, this year’s Media Maven Award goes to Robb Dixon. In addition to conducting the aforementioned interview with Dr. Peters, SIDEfxHUB’s Communications Director appeared on Good Morning Britain to warn viewers of finasteride’s potential dangers. On February 11, he told hosts Susanna Reid and Ed Balls that he quit the drug after six months due to mild sexual dysfunction and brain fog. But then:

“All hell broke loose… A complete and utter collapse of my health with neurological, sexual and physical problems. They manifested almost instantaneously. It actually woke me up out of my sleep… It must have been four or five in the morning—10 out of 10 anxiety,” said Robb. 

“I’d never experienced anxiety like this before. I had no mental or physical health issues prior to taking finasteride. Water just pouring out of the palms of my hands. Blaring tinnitus. Visual snow—like a de-tuned TV across my whole field of vision.”

Meanwhile, just as our reporting year was drawing to a close, an unexpected postscript arose.

FOR THE RECORD

P.S. (Pattern Surveillance)

If you’d told me in 2021, after Merck spun off Organon—and packed Propecia along with it—that Kevin Ali would be gone four years later, I’d have dismissed you as a cockeyed optimist.

The man Merck chose to build what it touted as “the world’s leading women’s health company” had been handsomely rewarded for the assignment. In 2021, the year Organon became an independent company, his reported compensation totaled $16.8 million. By 2025, he was history.

But not for nothing.

As Reuters reported October 27, “Ali will resign from his role after an internal investigation into sales of its Nexplanon contraceptive implant to wholesalers pointed to ‘improper’ practices.” Those improper practices involved encouraging some U.S. wholesalers to buy more Nexplanon than needed at the end of several quarters between 2022 and 2025.

Although the practices affected less than 1% of annual consolidated revenue in 2022 and 2024, they helped Organon meet quarterly forecasts and external revenue expectations.

Organon also disclosed that Ali agreed not to receive severance or equity-related retirement benefits in connection with his resignation. Had he been terminated without cause, his severance plan would have entitled him to $6.25 million in pay, plus a prorated annual incentive and other benefits worth roughly $1.9 million.

While none of this involved Propecia, it did prompt me to lean in thisclose.

Passing the $11.75 Billion Bucks

On April 26, 2026, six months after Ali’s departure, Organon agreed to be acquired by Sun Pharmaceutical Industries in an all-cash deal worth about $11.75 billion.  

It marked the largest overseas acquisition ever by an Indian pharmaceutical company. But to the accidental investigator, that wasn’t the deal’s most notable element.

On June 25, 2022, one year after we’d unveiled our Propecia Litigation Library, we launched an interactive map plotting all the nations known to have issued warnings of finasteride’s potential to cause persistent symptoms. To do that, we’d audited drug regulator websites in more than 100 nations, coming up with 53 at launch, including superpowers China and Russia.

An admirable start, but with roughly 190 drug-regulatory authorities on earth, plenty of territory remained unexplored. So every quarter since then, we’ve audited the remaining regulators, coming up with three additions to our Global Warning Map: Japan, Malaysia, and South Africa.

One nation nonetheless continues to elude us; one that’s regularly described as an emerging superpower; one that, in April 2023, became the most populous nation on earth:

India.

And therein lies an uncomfortable rub. Assuming the acquisition closes early next year as projected, Sun will become the owner of Organon, and with it the Propecia business that Organon inherited from Merck.

Yet our regular reviews of India’s drug-regulatory databases and public-safety communications have never identified a warning that finasteride can cause persistent side effects, including serious neuropsychiatric reactions.

*    *    *

As we embark on Year 15 of our mission, we ask everyone to donate generously so that we may continue this urgent work.

In the meantime, as directed on our Report Your Side Effects page, anyone living in the US who suffers from PFS should report his or her symptoms to the FDA. Anyone living outside the US who suffers from the condition should also report to the FDA, as well as to his or her local DRA.

Finally, if you or a loved one are suffering from PFS and feeling depressed or unstable, please don’t hesitate to contact us via our Patient Support hotline: social@pfsfoundation.org

Sincerely,

Philip Recchia
President

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