March 13, 2025
Dear Friends:
You’d think that any organization pushing a prescription medication on the public would be required to disclose its potential dangers alongside its benefits.
But when it comes to US telehealth firms—which boast a $54 billion annual market—you’d be wrong.
Business Bible’s scrutiny
The Wall Street Journal today published an investigative report (They Wanted a Quick Fix for Hair Loss. Instead, These Young Men Got Sick) examining the correlation between ever-easier access to finasteride from companies like Hims and Keeps, and an upswing in the number of finasteride patients reporting persistent adverse reactions to the drug.
“Sawyer Hart was 27 and healthy when he got his finasteride prescription from Keeps in 2023. A week in, Hart experienced erectile dysfunction, so he stopped taking the drug. After that, unexplained panic attacks kept him home, and he was later hospitalized,” reports Rolfe Winkler, who covers digital health exclusively.
In addition to Hart, the paper spoke to 16 other PFS patients who were prescribed generic Propecia (finasteride 1 mg) by telehealth companies, including former US Army sergeant, and current YouTube crusader, Mark Millich.
“Soon after taking the medicine, Millich said he felt strange symptoms. He woke up one day anxious, dizzy and slurring his words. Later his libido plunged, and his genitals shrank and changed shape,” writes Winkler. “His doctor said the symptoms were caused by [finasteride.]”
(So compelling were Millich’s adverse reactions to finasteride that within hours of the WSJ publishing its story, the DailyMail.com—the world’s most popular online newspaper—published its own version, headlined My genitals shrank and changed shape. Doctors discovered surprise culprit that should terrify men.)
Most all the PFS patients interviewed by the WSJ complained that they weren’t aware the hair-loss medication carried any risks of serious side effects. Some said as well that what scant warnings they were given were inadequate.
Old news, to us
The PFS Foundation first brought this alarming trend to light more than two years ago, in the wake of the US Food and Drug Administration’s mandate that suicidality be added to the Propecia label, which had come about as a result of the Citizen Petition we’d filed five years earlier.
When the August 2022 deadline for that label change arrived, Organon, which owns Propecia, had indeed updated the drug’s label as directed. Other major dispensers, however, apparently elected to flout the federal directive, prompting us to report:
Since their foundings in 2017—the Big 3—Hims, Keeps, and Ro—have raised about $1.3 billion in venture capital, according to CrunchBase, giving them ample means to aggressively target men looking for hair-loss treatments…
The problem is, according to [our] review of all three telemeds’ consumer digital content, not one of them, as of press time, has followed Organon’s lead by swapping in the revised Propecia [Prescribing Information] containing suicidality ADRs. Meanwhile, more and more PFS patients who contact us for help tell us that they were prescribed finasteride by Hims, Keeps or Ro, among other telemeds.
Mum’s the word—and it’s OK with the FDA
Now, more than two years later, another facet of the problem is rearing its head.
“Finasteride…has been on the market for three decades with potential side effects including sexual dysfunction and depression. But a new generation of young men are discovering the medicine—and its potential risks,” writes Winkler.
“That is largely because they are peppered with ads on social media pitching hair-loss medications from telehealth companies, which unlike drugmakers aren’t required to disclose side effects and other risks in advertisements. It is a loophole telehealth companies have long exploited to sell medicines.”
Hims & Hers Health, Inc. (HIMS), the one publicly traded company among the Big Three, closed the day down more than 7%. Year to date, the stock is off more than 30%. In 2024, Hims raked in $1.5 billion in revenue from more than two million customers.
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.