MHRA Announces New Warnings for Suicide and PSSD

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.