On 15 October 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced new warnings for SSRI and SNRI antidepressants. These will include a new boxed warning in the patient information leaflet for suicidal thoughts and behaviours, a new patient card, a supporting safety leaflet, and the addition of the term post-SSRI sexual dysfunction (PSSD) in the patient information leaflet.
The full document along with a background research document and ‘Patient Card’ can be found HERE. There is a further post to come on withdrawal – RxISK was well represented at this also.
This post is put together by several RxISK players.
How did this come about?
Back in 2018, RxISK wrote and submitted a petition to the MHRA, the European Medicines Agency, and the US Food and Drug Administration (FDA). We requested warnings about persistent sexual dysfunction to be added to all SSRIs and SNRIs. This was on the back of a new study that we had recently published, 300 Cases. Additionally, we provided a large amount of supporting data to the European Medicines Agency including individual named reports and letters from healthcare professionals. We offered the same to FDA.
It resulted in warnings about persistent sexual dysfunction being added across Europe and the UK. Other countries have since followed suit including Ireland, New Zealand, Canada, Hong Kong, Australia and Malaysia. However to date, the FDA has failed to provide a decision on the petition and did not take up our offer of further information. This is all the more bizarre given that they acted upon our subsequent petition about isotretinoin. They have confirmed to us in writing that our SSRI/SNRI petition is still ongoing and no decision has yet been reached.
Some of us figure MHRA would not have done what they have done last week without getting the nod from FDA. And MHRA have mentioned getting agreement to these changes from almost all the pharmaceutical companies – so let’s see if there is movement on the FDA front soon.
Many people, including us, felt that the 2019 warnings were not strong enough. One problem was that they simply referred to “sexual dysfunction” which was quite vague. Neither patients or healthcare professionals could be expected to interpret this phrase as genital numbness and pleasureless orgasm. It also allowed doctors to continue conflating PSSD with a loss of libido that could be attributed to mental problems. People wanted either the individual symptoms of PSSD to be listed, or the name of the condition, or ideally both.
Since then, many more groups and individuals have attempted to liaise with MHRA to push for stronger warnings, in some cases trying to enlist the help of members of UK parliament. This new development is likely the cumulative effect of these efforts, bolstered by the previous petitions and warnings, as well as the condition becoming increasingly well established in the academic literature. The publication of diagnostic criteria and the introduction of codes from MedDRA and SNOMED have also helped to solidify PSSD as a diagnostic entity in its own right.
In terms of suicidal thoughts and behaviour, SSRIs and SNRIs already carry warnings. However, these warnings generally focus on children and young adults when, in fact, these adverse reactions can affect people of all ages. The current warnings also give the impression that these thoughts and behaviours are an exacerbation of a mental problem you already have. But the reality is that antidepressants can cause suicidal thoughts and behaviour in completely normal people with no history of mental disorders. See Experiment at the End of the Millennium for more about this issue. It’s a fascinating read.
What does this mean?
This will be the first time that PSSD has been specifically named in the patient information leaflet for any SSRI or SNRI in any country, and so it’s another step forward in terms of raising awareness of the condition. But in reality, this development probably means very little and is unlikely to have the effect that some people are hoping for.
It is also difficult to give the MHRA much credit. They have indicated that their first report of a sexual dysfunction continuing after an SSRI was stopped was in 1991. Despite this, it wasn’t until a huge effort by RxISK in 2018 that they added warnings, and only in 2026 that they will add the name of the condition.
It remains to be seen what the new warnings about suicide will say and whether anyone will take notice.
What this does not mean
Part of the push for warnings hinges on the idea that our consent to treatment should be informed. But it is a mistake to think that simply giving a list of problems is going to inform consent.
Taking a drug like an SSRI is like learning to ride a bike. Ideally if you and your doctor agree to go ahead with treatment, you should be given something like a 3 day course of the equivalent of 5 mg of Prozac and asked to keep an eye on how you feel on this. You should ask family and friends to feed back any changes they spot in you. Many of the key changes will be visible in hours or day – genital numbing may be there within 30 minutes.
Then you should stop treatment for 3-4 days before going back to see your doctor – as you will spot effects the drug had when you stop that you might not have picked up while taking it. If after this you think you would be able to live life with genital numbing and muted orgasm like this if it were to persist for the rest of your life, you are closer to having the capacity to consent than you would be from simply reading a list of potential effects.
There is another matter not touched on. In the case of PSSD and both suicide but especially homicide on these drugs, shouldn’t the partner of anyone starting treatment be informed of the potential consequences for her or him?
Humor
The combination of MHRA and AI may bring a smile to your face. If you open the patient card, it is likely AI will tell you it can summarise this for you. AI usually tells us this is a long document and it can summarise it for you. The patient card is not long..
We may not all have the same AI but at its very best AI might save a word or two on the original very few words – at a cost of making if if anything less coherent. AI is definitely giving the impression it is principally concerned to be seen to be doing something in this case (taking you over) rather than interested to add cutting edge value. It’s being a perfect bureaucrat. The original document may well have been written by AI.
Toxicity
MHRA steer a million miles away from branding PSSD as a toxic state. They downplay it’s likely frequency. But more to the point, they don’t tell anyone that there is no research happening on establishing what underpins PSSD or how to treat it, other than the research being done by people with PSSD.
This should be shocking but it’s not. It’s another example of the Dogs Bark, the Caravan Moves on. Back nearly 40 years ago, the companies marketing SSRIs used the injuries caused to thousands by indiscriminate benzodiazepine use as marketing copy for the need to switch from benzos to SSRIs. SSRIs were going to be the proper treatment people should have had all along. But in the last nearly 40 years, no company or government has made any effort to establish what can be done to remedy the enduring benzodiazepine injuries and there will be no effort made to remedy SSRI injuries.
No-one with PSSD should expect, and we imagine few if any do expect, that there will be any support for research to understand what has happened and how to remedy it.
None of us or our doctors will be skeptical of the next generation of wonder drugs – like the Glip1 agonists.
Vortioxetine
When EMA listed sexual dysfunction in small print in 2019, they made it clear this didn’t apply to the Vortioxetine label supposedly because they did not have enough information that it also caused the problem. We had reports from several vortioxetine users back then and have far more now – enough for RxISK to say vortioxetine (Trintellix – Brintellix) causes PSSD.
A likelier explanation for the omission of vortioxetine is that it was then and is still in some places on patent. And both regulators and pharmaceutical companies have a greater felt need to look after the health and wellbeing of pharmaceutical companies than they have to look after ours,
Anonymous
One oddity to the documents is that the members of the expert working group are not named. Why? What those who have been injured by treatment possibly fail to understand is their ‘betters’ are scared of them. They expect social media vilification and worse – not realizing that most of the nastiest trolling on social media comes from senior figures of the medical professions.
The best example of this was Daniel Casey who chaired the 1991 FDA Hearing on Prozac and suicide – wearing a bullet-proof vest under his shirt and jacket.
Chris says
Actually, I do expect there will be research on this. AI/ML is also increasingly in public hands, plus not every health system is privately funded.
Dr. David Healy says
Chris
Research on what – suicidality or PSSD? AI isn’t going to do research. It will be people who do it – and I can see those already affected continuing to do it as they’ve done before AI was a blink in anyone’s eye and they may use AI now but the risk with AI is that you will get locked into an echo chamber
D
Anne-Marie says
I asked ai if ai/ml can predict ssri alcohol cravings. This is what it says below. It looks like it just uses the information already out there. I was hoping ai could think for itself.
Yes, AI and machine learning (ML) can predict the risk and pathways of SSRI-induced alcohol cravings
, though it is an emerging area of precision psychiatry. While some people find that Selective Serotonin Reuptake Inhibitors (SSRIs) reduce their urge to drink, a specific subset of patients experiences an intense, paradoxical surge in alcohol cravings and impulsivity after starting these antidepressants. [1, 2, 3]
AI/ML models do not look at a single cause; instead, they integrate multi-dimensional datasets to build predictive “early-warning” models. AI approaches track and predict this phenomenon through several interconnected mechanisms: [1]
1. Genomic and Molecular Modeling
2. Pharmacokinetic and Exposure Modeling
3. Neuroimaging (fMRI) & Connectome Mapping
4. Digital Phenotyping and Natural Language Processing (NLP)
Summary of AI vs. Traditional Approaches
Predictive Domain
Traditional Approach
AI/ML Approach
Genetics, Brain Activity, Behavioral Triggers
Dr. David Healy says
I’ve greatly shortened this comment as AI spends a lot of time saying nothing and the more time just repeating the more you’d figure its not got a lot to offer – yet anyway. As a tool for someone to guide toward issues that might reveal something it may be more helpful
D
Jo Ann Cook says
The core warning on antidepressants has existed for two decades. Despite this warning a massive campaign took place in Canadian schools in early 2000 instructing children and teenagers to accept the erroneous belief that antidepressants are helpful and necessary to solve life challenges. The result of this campaign is an astronomical surge in student violence. See link below. Yet our educators continue to look for other excuses for this violence, such as more psychologists and social workers are needed.
The industry propaganda fed to students and teachers is that mental health drugs such as antidepressants create successful adult lives, free of auto accidents, school failure, drop outs, divorce, suicidal behaviour, unemployment and criminal behaviour, such as violence. The opposite is true,
Simon Davison, a Canadian psychiatrist and one of the main participants of the creation of a false mental health school curriculum was reported to favour targeting young minds as “they are more receptive to new information”. He was a key player in making “a major move” of ,services, more often antidepressants and other psychiatric drugs into elementary and high schools. His vision of “schools as a hub for the early diagnosis and treatment of mental health disorders” is a reality today. Davidson received funding from Eli Lilly, Pfizer, and Smith-Kline Beecham, now GlaxoSmithKline.
Thank you for alerting readers to the new warnings. This information needs to be disseminated to our schools, The educational curriculum is devoid of any warnings. Our youth are being captured by the industry and are the future enablers of antidepressants in their peers. The exploitation tools even include having students ratting on their fellow students who may have life challenges.
No youth under 21 should be on antidepressants, similar to the restrictions of alcohol. The medical industry is complicit in this ongoing disaster,, making our youth suicidal and increasingly violent in our schools. I witnessed the development of this morally reprehensible trend in our schools and documented its rise in the book Making Healthy Children Sick What the Mental Health Industry Is Not Telling You.
Thank you again.
Read in The Globe and Mail: https://apple.news/ANvbxUeroRkSxBNDiX8Wt1Q
tim says
“Taking a drug like an SSRI is like learning to ride a bike. Ideally if you and your doctor agree to go ahead with treatment, you should be given something like a 3 day course of the equivalent of 5 mg of Prozac and asked to keep an eye on how you feel on this. You should ask family and friends to feed back any changes they spot in you. Many of the key changes will be visible in hours or day – genital numbing may be there within 30 minutes”.
“Then you should stop treatment for 3 – 4 days before going back to see your doctor – as you will spot effects the drug had when you stop that you might not have picked up while taking it. —– ”
What an invaluable evidence-based NICE Prescribing Guideline these words of wisdom would make.
Urgently needed, evidenced, life saving and family suffering preventing SAFETY FIRST PRESCRIBING.
This policy would have saved our loved one and allowed a joyous, gifted and fulfilling life to continue.
Thank you.
If only all prescribers could understand and accept this.
If only all Vocational Trainees in General Practice could be taught this.
Mrs Fiona Mills says
I was on Lithium therapy for nearly 25 years for the treatment of diagnosed bipolar disorder. I was repeatedly told of the dangers posed by falling outwith the very narrow therapeutic range and the necessity for regular blood tests and immediate action, particularly if blood test results came back higher than the top end of the range. Last year, I unintentionally lost 14kg in weight, which altered my serum levels of lithium and thyroxine. My medical practice failed to alert me that I had thyrotoxicosis and a few months later, that I was above range for lithium. I had lithium toxicity symptoms. When I phoned to find out my blood test result, I was told that I was slightly above the normal lithium range but the doctor was not concerned so no further action was necessary. I had to call back to ensure that I had symptoms of toxicity and that I should have been approached to verify the existence of toxicity symptoms. An unapologetic GP simply told me to decrease the dose, repeat the blood test in a couple of months to “see if I was still within the therapeutic range” There was no mention still, of my thyrotoxicosis status. Furthermore, over the course of the previous 5 years, I had requested cessation of lithium therapy as I had never felt any benefit and actually believed that it was doing more harm than good. Warned off doing so, every time. Also during the whole lithium therapy, I was also given many different SSRIs, changing each one after perceived benefits were short lived or non existent. I lost track of how many times I dipped into suicidal ideology and the number of intentional attempts at ending my life. From the age of roughly 33 to nearly 55, I was an in patient at a psychiatric hospital well over 20 times, ranging from a few days to 6 weeks. Earlier this year (2026), I made the decision to titrate myself off lithium. ONE week post lithium, I thought a miracle had happened. Lack of energy, crippling fatigue, brain fog, a new vastly improved clarity of thought, suicidal ideology completely vanished, libido returned, the constant heaviness that had weighed down on me was gone. ONE week! Even while recovering from a now full blown endocrine/metabolic crash, present but not reported to me before I stopped taking lithium, I still felt so much better and could think clearly enough to pursue a referral to an endocrinologist to sort out the clinical mess I was in. I then titrate myself off the SSRI Escotalopram, which I had been prescribed on and off for about 2 years.
Yes, I agree that honest labelling on these powerful psychiatric drugs is absolutely necessary, I feel that monitoring individuals and actually taking on board an individuals concerns about any aspect of use of these therapies requires investigation. I feel failed by a system that was supposed to protect, treat and monitor me. I was allowed to become seriously ill with no intervention. Any concerns I raised seemed to be dismissed. More frustrating is the fact I have a degree in physiology and a masters in analytical chemistry and had started a career in research and development, to which medicine was interwoven. I believe that my expertise in research saved my life. And yet, no one would have an honest conversation with me. Oh and at age 53, I was finally recognised as being high functioning autistic, something I had voiced for over 20 years. Both grown children have autism and autism is in my family. Perhaps it’s time to start listening more to what patients have to say? And not just reach for the prescription pad to offer another powerful, potentially damaging or life threatening drug while leaving that person to carry on, business as usual, without adequate or any boots on the ground support and put the onus on us, who are already under extreme mental health pressure, to somehow negotiate a hostile system, which is difficult enough to access as it is, to report any symptoms, concerns or simply have questions answered honestly and in a timely fashion.
I may not have been around to post this, many times. I survived to tell the tale. I’ve lost close friends to suicide and nearly lost friends to, in my opinion, medical negligence. So who’s next?