How PSSD, PFS and PAS warnings got on leaflets
How finasteride got its warning card, how isotretinoin's lasting sexual side effects reached the label, and the part your reports play.
Ever read your leaflet and asked who decided what goes in it? Antidepressant, finasteride and isotretinoin leaflets got their warnings once side-effect reports built up and a regulator reviewed them. They now warn that sexual problems can last after stopping, the warnings behind PSSD, post-finasteride syndrome (PFS) and post-Accutane syndrome (PAS).
Each line has a dated paper trail, and it starts with people reporting what happened to them.
Sam’s interview shows the gap a leaflet line can leave. He took finasteride for hair loss and read that erection problems might happen.
Was anything said about them lasting? “Nothing permanent,” he says. His story is on our site, and it’s the kind of account that starts the process below.
So how does a report become a leaflet line, and what can you add to the record?
How does a side effect get on a leaflet?
It starts with a report. A patient, a doctor or a pharmacist tells the regulator they suspect a medicine caused a problem. In the UK that’s the Yellow Card scheme, and the MHRA says only a suspicion is needed.
Reports go into a database alongside published studies. When they point to a possible pattern, the EU medicines regulator calls it a signal: information on a side effect that “may be caused by a medicine and requires further investigation”.
Its safety committee then assesses the signal. The regulator says the outcome can be no action for now, a request for more data, or a change to the product information. That change is made through a “variation”: the company updates the leaflet with the wording the regulator sets.
Someone suspects a medicine caused a problem and tells the regulator.
Reports, studies or other sources point to the same pattern.
Experts weigh the evidence and decide what, if anything, should change.
The company updates the leaflet with the wording the regulator asked for.
The antidepressant warning shows each step. In 2019 the EU’s drug safety committee looked at reports in its database, published studies, social media and reviews sent in by the companies.
On 16 May 2019 it asked the makers of six SSRIs and four SNRIs to submit that variation within two months. The new leaflet line reads: “In some cases, these symptoms have continued after stopping treatment.” UK leaflets carry the same line: you’ll find it in the Cipralex leaflet today.
The line doesn’t use the name PSSD. In October 2026 the MHRA said the name will be added to the leaflets of some UK antidepressants. Our page on what regulators say about PSSD follows that story.
The leaflets only mention sex, but these conditions are more than that. Proposed criteria from 2022 describe, for PSSD, a lasting change in genital sensation, often numbness, plus emotional numbing, problems with cognition and changes in other senses. For PFS they also list problems with cognition and depression.
How did finasteride get its warning card?
In two stages: first a leaflet line, then a card in every pack. In 2010 the product information was updated. It said erection problems that continued after stopping had been reported after the medicine went on sale.
The second stage was about who knew. The MHRA began a new review in 2023 because patients were worried about “the apparent lack of awareness” of these side effects among health professionals and patients. It searched the Yellow Card database and found 375 reports of sexual or fertility problems with finasteride between 1992 and January 2023.
Most of those side effects were already in the leaflet. So the MHRA’s expert advisers recommended something new: a card inside every pack, saying sexual problems have sometimes continued after stopping. The MHRA announced it in April 2024.
How did isotretinoin’s lasting sexual side effects get on the label?
In the UK, through an expert review that began in September 2019. It looked at Yellow Card reports, studies and evidence from patients and families. In April 2023 the MHRA said the product information would warn of “reports of long-lasting sexual dysfunction” after stopping isotretinoin.
The same review said it was “not possible to say” that isotretinoin definitively caused many of these effects. A leaflet line records a risk that has been reported. It isn’t proof.
In the US the route was a petition. David Healy, a professor of psychiatry, asked the FDA in 2018 to warn about lasting sexual problems.
In June 2026 the FDA told the makers to add “sexual dysfunction that may continue after discontinuation of treatment” to the label’s list of side effects. The line didn’t go into the label’s separate warnings section, and our article on the FDA’s isotretinoin decision explains why.
“Any mention in the label gives the person affected a better footing in their dealings with doctors,” Healy wrote afterwards.
What can you do?
These medicines help many people. If you have side effects, that’s a decision for you and your prescriber. For antidepressants, don’t stop suddenly. For finasteride and isotretinoin, follow what the leaflet says.
Taking it to your GP
You could start with: "My leaflet says these problems can continue after stopping. I think that's what's happening to me."
- Can this go in my notes as a suspected side effect?
- Will you send a Yellow Card report, or should I?
- What else could explain my symptoms, and how do we check?
Report it: it helps everyone
A doctor’s note helps you. A report to the medicines regulator helps everyone else: it is how patterns get noticed.
- No proof needed. A suspicion is enough, even years after stopping.
- Where: the Yellow Card scheme in the UK, MedWatch in the US.
- Use the right words. For an SSRI or SNRI antidepressant, write Post-SSRI sexual dysfunction (MedDRA 10086208). For finasteride, write Post 5-alpha-reductase inhibitor syndrome (MedDRA 10082430). PAS has no term yet, so say the symptoms continued after you stopped isotretinoin.
Our reporting guide walks you through it
What else do people ask?
Does a warning on the leaflet prove the medicine causes it? No. It means a regulator has reviewed the reports and decided people should be told. No reliable figure exists for how often these effects happen, and the leaflets don’t give one. Our pages on PSSD, PFS and PAS set out what is known so far.
Why do leaflets differ between countries? Each regulator runs its own review and sets its own wording, so the lines differ. If you quote one, give its country and date. Our pages on PSSD warnings around the world and isotretinoin warnings list what each says.
Do reports from patients really count? Yes. Each review above used patients’ reports or accounts. The EU’s 2019 assessment also looked at social media. Using the right MedDRA term helps your report land in the right place, as our page on PSSD and PFS codes explains.
Sam read about erection problems, but “nothing permanent”. If yours have lasted, report it: the lines about lasting effects in today’s leaflets began with reports like yours.
Sources
- European Medicines Agency, PRAC. Recommendations on signals adopted at the 13–16 May 2019 PRAC meeting, EMA/PRAC/265212/2019, section 1.3, EPITT 19277, adopted 16 May 2019. Evidence: EudraVigilance, literature, social media and cumulative reviews from the companies. Variation to be submitted “within 2 months” for citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, duloxetine, venlafaxine, desvenlafaxine and milnacipran. Package leaflet wording, section 2: “In some cases, these symptoms have continued after stopping treatment.”
- European Medicines Agency, Signal management, accessed 21 October 2026. Definition of a signal; PRAC prioritises and assesses signals; possible outcomes include updating the product information through a variation. “The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event.”
- MHRA, The Yellow Card scheme: guidance for healthcare professionals, last updated 24 July 2025: “You do not have to prove causality to report a suspected ADR.”
- MHRA, Finasteride: review of safety data and expert advice on management of risks, 29 April 2024. The full report (PDF) gives the reasons for the review (section 1) and the 2010 update on lasting erection problems (section 3.3). It also gives Yellow Card data to 5 January 2023, 375 reports with sexual dysfunction and fertility disorders from 27 November 1992 (section 5.2); the patient card recommended by the Pharmacovigilance Expert Advisory Group (sections 6 and 7, annex 1).
- Cipralex (escitalopram) patient information leaflet, UK, electronic medicines compendium, section 2.
- MHRA, Isotretinoin (Roaccutane): new safety measures to be introduced in the coming months, Drug Safety Update, 26 April 2023. Review by the Commission on Human Medicines’ Isotretinoin Expert Working Group, set up in September 2019, using Yellow Card reports, published studies and a public call for information.
- MHRA, Antidepressants: new safety measures, Drug Safety Update, 15 October 2026: the term “PSSD” will be added to the leaflets of antidepressants associated with a risk of sexual dysfunction that may continue after stopping.
- Absorica and Absorica LD (isotretinoin), US prescribing information, DailyMed, revised August 2026. Section 6, Adverse Reactions, Reproductive System: “sexual dysfunction that may continue after discontinuation of treatment”. FDA response to citizen petition FDA-2018-P-4088, letter to David Healy dated 16 June 2026, posted 17 June 2026 (petition received 29 October 2018; Adverse Reactions entry granted, Warnings and Precautions entry denied); and FDA, labeling updates for generic isotretinoin, 17 June 2026.
- David Healy, Regulators Bearing Gifts, davidhealy.org, 20 June 2026.
- Healy D, Bahrick A, Bak M and colleagues. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med 2022;33(1):65-76. Proposed criteria. Section 3: ancillary symptoms of PSSD include “emotional numbing”, “cognitive impairment” and “other sensory problems”; section 5 covers PFS.
- Videos: Moral Medicine, The Hidden Devastation of Finasteride – Sam’s Story, June 2025, “nothing permanent” at 4:32; NHS Black Country Integrated Care Board, What is the Yellow Card Scheme?, Medicine Safety Week, November 2021.
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