Dear Friends:
The British are coming—to terms with the fact that most finasteride patients have no idea the drug can cause persistent sexual dysfunction and suicidal ideation.
But in the heartbreaking case of Paul Andrew Dixon, that realization came a decade too late.
In September 2014, the UK native began taking finasteride as directed in the patient information leaflet (PIL), which had recently been updated to include warnings of “depressed mood,” and ED that failed to resolve after quitting the medication.
“Depression,” “anxiety,” and “suicidal thoughts,” however, weren’t added until 2017, two years after Paul took his own life due to those very same (and then some) side effects.
He’d just turned 31, and was just a few months away from his wedding day.
Britain sounds second alarm
In April 2024, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Drug Safety Update alerting health care pros that finasteride patients risk developing psychiatric and/or sexual side effects that can persist post-treatment.
The hallmark of this public-health campaign, scheduled for implementation by year end, will be a patient card packed into all finasteride products, including Propecia (finasteride 1 mg, for hair loss) and Proscar (finasteride 5 mg, for enlarged prostate), as well as generic versions of both drugs. It reads, in part:
This medication can cause side effects including depression. In some cases, it may lead to having thoughts of suicide.
Additionally, the following guidelines have been set forth for health care pros:
• Before prescribing finasteride, ask patients if they have a history of depression or suicidal ideation.
• Advise all finasteride patients to read the PIL, which contains a full list of known possible side effects, and to tell family and friends that finasteride can negatively impact psychological well-being.
• Advise patients prescribed finasteride 1 mg to quit immediately if they develop depression or suicidal thoughts, and to contact their doctor asap. Advise patients prescribed finasteride 5 mg to consult their doctor asap if they develop depression or suicidal thoughts.
• Monitor all finasteride patients for psychiatric and sexual side effects, and report adverse drug reactions (ADRs) to the MHRA’s pharmacovigilance database, aka Yellow Card scheme.
A previous Drug Safety Update, citing reports of depression and suicidal ideation among finasteride patients, was issued in 2017. But back then, there was insufficient evidence that those ADRs could persist, says the MHRA.
Global pharmacovigilance groundswell
This new finasteride alert marks the fifth such action by a drug regulatory authority (DRA) in less than two years:
• USA: June 2022. As the result of a Citizen Petition filed by the Post-Finasteride Syndrome Foundation, the Food and Drug Administration ordered Organon & Co., the Merck & Co. spinoff that now owns Propecia and Proscar, to add “suicidal ideation and behavior” to the Prescribing Information of all finasteride 1 mg products.
• France: December 2022. The National Agency for the Safety of Medicines and Health Products announced plans to add a so-called red-box warning to all finasteride 1 mg products, which reads, “This medication can cause side effects, including psychiatric and/or sexual disorders.”
• Japan: August 2023. The Pharmaceuticals and Medical Devices Agency published a disproportionality analysis of suicidality Adverse Drug Reactions associated with finasteride and dutasteride. (Like finasteride, dutasteride is a 5 alpha-reductase-type-2 inhibitor, and is used to treat enlarged prostate, but was originated by GlaxoSmithKline.) For suicidal ideation, the expected number of ADRs was 43, but the actual number was 470, representing a 993% increase. For completed suicide, expected ADRs was 40, but the actual number was 148, a 270% increase.
• Canada: January 2024. Health Canada informed health care pros that “The Warnings and Precautions and Patient Medication Information sections of the Canadian product monographs [aka, labels] for Propecia and Proscar have been updated with the risk of mood alterations [including] depressed mood, depression, self-harm injury [and] suicidal ideation.” HC also reported that, within its own database, it found 23 cases of “suicide, suicidal ideation and/or self-injury…possibly linked to the use of finasteride.”
For a listing of all nations known to have issued PFS warnings, please consult our PFS Global Warning Map.
Patient-prompted probe
The MHRA’s latest safety investigation was launched last year after several long-term PFS sufferers raised concerns that health care pros and new finasteride patients alike are egregiously unaware of the drug’s many potential dangers. The most vocal among those sufferers was Ryan Clark.
Ryan, 57, who spent most of his career employed by Her Majesty’s Government, was stricken with PFS in 1998, and has since developed a dizzying array of health woes including adrenal dysfunction, autonomic dysfunction, androgen deprivation, benign tumors, chronic insomnia, cognitive dysfunction, dermatological disorders, gastrointestinal disorders, generalized anxiety disorder, global soft tissue atrophy, muscle atrophy, neuropathy, suicidal ideation, and sexual dysfunction.
He began contacting the MHRA in July 2021, to lobby for more vigorous warnings on finasteride packaging, and tighter guidelines on prescribing the drug, but was repeatedly rebuffed. It wasn’t until February 2023 that an MHRA medical assessor wrote to tell him the agency had jumped head-first into a new finasteride probe.
Tightening the leash on telemeds
The agency spent more than a year at that task—analyzing finasteride ADRs, studying medical literature, reviewing safety requirements for drug makers, engaging with scientific experts and patient groups, and assessing actions taken by foreign DRAs.
Such input was then compiled into a Public Assessment Report (PAR) titled Safety Review of Finasteride, which focuses heavily on the problem of fast-and-loose access to the drug via digital-health providers, aka telemeds. Notably:
• “Propecia is commonly prescribed online, which may increase the risk that [persistent sexual and psychiatric] side effects are not communicated sufficiently.”
• “Regarding the prescribing process for finasteride, the MHRA met with online pharmacies, and while some do have thorough screening and monitoring processes in place, others do not.”
• “We also engaged with Digital Clinical Excellence, which aims to provide a collective clinical voice for digital healthcare providers. They created Best Practice Guidelines for online pharmacies prescribing finasteride.”
• “If the prescriber feels that a patient’s asynchronous form-based assessment does not provide sufficient information to make a safe prescribing decision…it may be that a telephone or video consultation…is needed.”
The PAR concluded: “It is clear, when looking at pharmacovigilance databases, there are increased signals for…suicide, depression, and sexual dysfunction.” Among the most recent data cited:
• The MHRA has received 281 Yellow Card reports of finasteride linked to depressed mood disorders and suicidal and self-injurious behaviors, and 426 associated with sexual dysfunction.
• Across both sexual dysfunction and depressive disorders, time to onset of symptoms was documented in 42% of total reports, with the average time to onset being 330 days.
• There were four fatal ADRs, listed as “completed suicide.” All were male, between the ages of 21 and 31 years old.
One of them was Paul.
Once upon a Tyne
The pre-PFS Paul was fun-loving and carefree, boasting an abundance of friends. In all likelihood, he had a long, healthy existence ahead of him.
Born in Newcastle upon Tyne, he spent his entire life there, never far from his loving family: mum Julie, dad Trevor, and older brother Philip.
After completing his studies at Bedlingtonshire Community High School, Paul earned a history degree at Northumbria University. Within a few years, he’d worked his way into Tesco Bank as a service-delivery analyst, helping the $20 billion institution maintain compliance and improve its customer experience.
Much of his leisure time was spent attending football matches with friends; enjoying the odd beer whilst supporting his beloved Newcastle United (NU). Never just a spectator, however, Paul would often be found on the football field (as well as the cricket field) competing in matches with his mates.
He had a knack, too, for imitating his idols. Like Kevin Keegan. Before serving as NU manager from 1992 to 1997, “King Kev” spent 17 years playing for six pro teams, including NU. In a 2008 YouTube video, Paul cracked his mates up with a spot-on rendition of the football legend’s “I will love it!” rant.
Second only to sports on Paul’s leisure list was travel. In December 2006, he jetted off to Melbourne for the Ashes, a biennial cricket series between England and Australia dating back to 1882. So enamoured was he by the Land Down Under that he stayed for nearly a year. Soon after landing, he landed a gig selling magazines, and made some amazing friends whilst he was there.
Along with those friends, Paul attended a bash to meet the cast of the daytime drama Neighbours. In attendance was the show’s newest face, an 18-year-old ingénue in the role of Donna Freedman—obsessive fan of pop star Ty Harper.
Few would have imagined that, 15 years later, she’d be the world’s highest-paid actress, having racked up such blockbuster roles as Leonardo DiCaprio’s wife in The Wolf of Wall Street, and Ryan Gosling’s sweetheart in Barbie.
But to Paul that night, Margot Robbie was simply another new friend in waiting. Thus armed only with an impish grin, he lured her over to his table for a snapshot.
“She asked us for a photo, so we felt it was only fair,” he later kidded on Facebook. “She was star struck with us lads!”
Growing concerns
By 2013, Paul was engaged to his girlfriend, and looking forward to exchanging “I do’s” at the alter. But each time he pictured that scene, worries about his thinning hair crept up on him. Needless to say, he wanted to look his best on the biggest day of his life.
After a while, he logged onto the website of The Belgravia Centre, which bills itself as “The UK’s Leading Hair Loss Clinic.” Without a prescription, nor live visual consultation of any kind, he was able to buy Propecia and have it delivered to his door.
He’d taken the drug a few years earlier, only to quit after, as he put it, “no longer wanting to be controlled by the drug.” But the stakes were higher now, so he figured going back on Propecia, just for the remaining time ahead of his wedding, would be safe enough.
Telling paper trail
Paul’s medical records paint a picture that would be hard to file under any heading other than “suicide stemming from finasteride use.”
In April 2015, eight months after restarting the drug, he was suddenly beset with anxiety. A month after that, he tossed his remaining pills in the rubbish bin.
By midsummer, Paul’s anxiety had not only persisted, it increased to the point where he could barely muddle through a workday. So first thing Monday, August 17, instead of heading off to Tesco, he drove straight to see his doctor at the Oxford Health Centre.
There, a GP noted Paul’s increasingly worse flare-ups of “panic attacks/anxiety,” prescribed relaxation exercises, and sent him home with a note dismissing him from work through month’s end.
Two days later, on August 19, Paul returned to Oxford Centre, complaining that his anxiety had grown worse. This time, another GP noted “no clear precipitant” for the condition, and that Paul was taking an over-the-counter sleep medication to help with insomnia. Then the GP prescribed the antidepressant citalopram.
On August 21, Paul yet again made his way to Oxford Centre, this time seeing his regular doctor, Katherine Elliott. She was the first to note that he’d been on finasteride for eight months, before stopping in May. Dr. Elliott ordered a range of tests to try and identify the root of his anxiety and weight loss. Then she prescribed zopiclone, a class C controlled medication used to treat insomnia.
At this point, Paul’s records showed that he had “good support from” his fiancée, felt “no stress at home,” was “getting married next year,” held a “good, stable job,” experienced no “low mood,” didn’t use tobacco products, and enjoyed, at most, three alcoholic drinks a week.
“So true,” Philip Dixon tells us. “Paul never smoked or took recreational drugs. He was always in good health, always happy.”
A week later, on August 28, Paul again saw Dr. Elliott (who, the day before, had asked a psychiatrist to weigh in on her patient’s case). She noted that Paul is “still anxious and is convinced he has post-finasteride syndrome… He has spoken to [Belgravia] and they said he will gradually get back to normal.” She noted, as well, two new symptoms: erectile dysfunction, and chronic dry mouth.
Over the next two months, Paul returned to see Dr. Elliott six times. Although he reported starting back to work part-time, sleeping a bit better, and the partial return of his sexual function, he also complained about low testosterone levels, irritable bowel syndrome, and incipient depression.
Meanwhile, Dr. Elliott had reached out to another specialist: endocrinologist Simon Pearce at Newcastle’s Royal Victoria Infirmary. His response wouldn’t arrive until four days after Paul died. But no matter. Because it read, in part:
I am afraid I don’t really know anything at all about post-finasteride syndrome. As this is the first I have heard of it, I am not in a good position to advise you. With best wishes.
Death of the life of the party
October 8 marked the beginning of the end for Paul, when he posted, in part, on a PFS patient forum:
I’m getting worse each day and I’m beginning to think I’ll be better off at peace and rid of all this horrendous pain. There’s only so much anxiety, insomnia, brain fog, testicular pain, depression, dry mouth, panic attacks, zombie-like state that I can take.
I’ve spent the last day or so looking over old pre-fin pics on Facebook and the great life I once had and I just think I will never get back to that… I will in my suicide note lay it bare so in death I hope I can stop this drug from ruining more lives.
On October 15, he again posted, in part:
I can barely leave the house I’m so anxious… Thinking of quitting my job to focus on recovery… Fingers crossed sleep improves, as this is compounding everything and stopping recovery.
Two days later, he vented his wrath publicly for the first time, tweeting to Belgravia: “FUCK OFF YA HORRIBLE VERMIN LOWER THAN A SNAKES BELLY”
On October 25, Paul emailed Belgravia, accusing them of ruining his life, and threatening to injur himself. When a police officer showed up at his door the next morning, Paul shared with him the events that prompted his outrage toward the clinic.
Later on, a street-triage team—mental health pros who collaborate with the police—deemed Paul stable enough to remain at home. Then they issued a note excusing him from work until November 28. According to the team’s report:
Paul said he had no plans or intent to end his life. He identified his fiancée and family as strong protective factors… Paul said he has not taken the sleep aid tablets [prescribed by Dr. Elliott] as he is worried about more side effects like he is currently suffering from hair loss treatment.
On the afternoon of October 28, the day after his 31st birthday, Paul stepped into his car, pulled out of his driveway, and sped a few kilometers up the road. Until he slammed into a tree, breaking his arm.
When his family asked if he’d meant to harm himself, or anyone else, he said no. He later told Dr. Elliott, however, “If I’d died in that crash, I wouldn’t have cared.”
To support Paul, his parents and brother spent all of Saturday, October 31, watching football with him. “Paul was still very anxious,” says Philip,” but by many indications, he was making his best efforts to cope.”
Paul’s family felt confident enough to leave him alone the next day, checking in only by text. He had a hospital appointment early Monday morning, to treat his broken arm, and his mum would be driving him there.
Monday arrived, and on her way to collect Paul from his home, his mum got a call saying he’d gone missing. His family then tracked him via his mobile phone. A few hours later, they came upon him in the woods, where he’d hung himself from a tree.
Paul was rushed to the emergency ward of the Royal Victoria Infirmary. Forty-eight hours later, he passed away.
No failure to warn
Fast forward to June 7, 2016. Karen Dilks, Newcastle’s senior coroner, has just completed an inquest into Paul’s case. Much of the evidence heard at that public hearing was presented by the Dixon family, who were resolved to make it clear that Paul was not crazy, nor was he even Paul by the time he died.
“We were always 100 percent convinced that finasteride put Paul into the mental state that made him take his own life,” says Philip. “It was a state that could not have looked more different than the brother, son, fiancé, friend and colleague loved by many here in Newcastle.”
One day after the inquest, Jim McDonald, a member of the Coroner’s Office staff, penned a letter to the MHRA. It read, in part:
Between 2009 and 2011 and April 2014 and May 2015 Mr Dixon took 1 mg of Finasteride daily to treat hair loss. In or around August 2015 he experienced symptoms of anxiety which became more profound in October 2015. On the 2nd November Mr Dixon hanged himself by a ligature causing Hypoxic Brain Injury and his death on the 4th November.
The Senior Coroner felt that this was important information that should be shared with you to assist in your Regulatory Role. She further hopes that the information will assist in updating the Patient Information leaflets that are distributed to those prescribed Finasteride.
“In the case of finasteride, ‘do no harm’ should mean never prescribing it at all,” says Philip. “But as it continues to be prescribed worldwide, we need to continually remind doctors that this drug could prove fatal to any patient.”
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar, and again in 1997, as Propecia.
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.