A longstanding problem for people with post-SSRI sexual dysfunction (PSSD) when trying to report their condition to drug regulators has been the absence of a code for PSSD. When regulators receive adverse event reports, they are coded against specific terms in their database which are usually taken from the Medical Dictionary for Regulatory Activities (MedDRA). Without a code for PSSD, it was only possible to record individual symptoms such as loss of libido, genital anaesthesia and erectile dysfunction.
This meant that cases of PSSD were somewhat hidden amongst reports of sexual side effects that were happening while on a medication. It was compounded by the fact that online regulatory databases often don’t indicate whether a reported adverse event persisted after the medication was stopped.
Towards the end of 2023, one of our team was investigating MedDRA codes related to sexual dysfunction and noticed a code for PSSD (10086208).
Further investigation revealed that it was added in 2021. Despite this, all of the evidence suggested that regulators were yet to adopt its use.
We were therefore pleasantly surprised to receive an email last week from someone linked to PSSD Network and RxISK who had recently written to the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The person had asked how many reports had been filed using the MedDRA code for post-SSRI sexual dysfunction, and they also asked for a breakdown by medication.
MHRA provided a detailed response and said they had received 33 UK reports up until 10 November 2024:
Sertraline 11
Citalopram 7
Fluoxetine 5
Escitalopram 4
Vortioxetine 3
Duloxetine 2
Amitriptyline 1
Lithium 1
Mirtazapine 1
Nortriptyline 1
Olanzapine 1
Venlafaxine 1
Adding up the numbers next to each drug comes to more than 33 because a report can list more than one drug. For example, a person may have been taking multiple drugs and might not be sure which had caused the problem.
As per the diagnostic criteria, PSSD relates to serotonin reuptake inhibitors eg. SSRIs, SNRIs, some tricyclics, and other related drugs. Lithium and olanzapine are not serotonin reuptake inhibitors. This raises an important point.
Some people claim to have developed PSSD from drugs that aren’t serotonin reuptake inhibitors and are unhappy when other people say their problem can’t be described in that way. There are many drugs that can cause various kinds of sexual side effects, and these can sometimes persist after stopping the drug, but this doesn’t necessarily mean it is PSSD.
PSSD isn’t a typical sexual dysfunction and has two very distinctive features – decreased genital sensation and pleasureless/muted orgasm. In addition, serotonin reuptake inhibitors produce some degree of genital numbing in almost everyone within an hour of taking the first dose. This effect appears to be unique to this class of drugs and highlights that this is a very specific disorder. Even drugs that can cause comparable features to PSSD such as finasteride and isotretinoin don’t universally produce immediate genital numbing upon taking, and are therefore regarded as separate conditions to PSSD, albeit potentially related.
Confusion can sometimes arise because symptoms can emerge upon stopping the causative drug. For example, a patient may be taking an SSRI and have relatively mild sexual dysfunction. They switch to a different type of drug and develop severe genital numbness. When they stop taking the second drug, the numbness doesn’t go away. They assume it was caused by the second drug because that’s when it occurred, but it may actually have been caused by stopping the SSRI.
None of this is to say that other drugs can’t cause persistent sexual dysfunction, but it’s important to make a distinction when it comes to labelling something as PSSD. As stated in the criteria article, antipsychotics and norepinephrine reuptake inhibitors can produce sexual difficulties that can sometimes persist, but this is not PSSD. A possible exception is the antipsychotic ziprasidone which also acts as a serotonin reuptake inhibitor.
Nortriptyline is usually thought of as a norepinephrine reuptake inhibitor, but it also inhibits serotonin reuptake. Mirtazapine acts on serotonin systems and can produce protracted withdrawal problems, akathisia, enduring sexual dysfunction and visual snow that look close to identical with SSRIs.
It isn’t known how these cases will be handled by regulators and whether they will be recorded as PSSD if it’s mentioned in the report, regardless of the suspect drug.
Reporting
It’s now possible to officially report post-SSRI sexual dysfunction to the UK’s drug regulator using their Yellow Card website, and this might be a good opportunity for anyone who is based in the UK to report their case. It might be worth specifically mentioning post-SSRI sexual dysfunction (MedDRA code 10086208) as well as listing individual symptoms so these can also be recorded against their specific terms.
The situation is less clear for those outside of the UK. For example, post-SSRI sexual dysfunction doesn’t appear in the list of searchable reactions in the FDA Adverse Event Reporting System (FAERS), which suggests it isn’t currently being used by the US regulator. However, FDA normally do use MedDRA, so pressure on them may be worthwhile.
Australia, Canada, New Zealand and European countries already have warnings in the drug labels, so it’s perhaps more likely that they will start using the code, or might have already started using it. Even so, it is still worth ensuring your case is coded with this MedDRA code.
It would be helpful if some of you could contact your country’s drug regulator to ask if they are using the new code and whether any reports have been received. Please let us know what they say.
Old reports are not typically reclassified when new codes are added to a regulatory database, so if you have previously reported your case, it probably won’t be recorded as PSSD. You would need to submit a new report.
We don’t know when MHRA started using the code for PSSD. Strangely, a freedom of information request that was answered by MHRA in April 2023 incorrectly claimed that “The term post-SSRI sexual dysfunction (PSSD) is not recognised by the regulatory dictionary – MedDRA.” We know that it was added by MedDRA in 2021, and MHRA’s recent letter confirms that. Given MHRA’s unawareness of the code in April 2023, they may not have started using it until after that time.
Other news
SNOMED
On 7 October 2024, Dr Mark Horowitz announced on X that PSSD had been added to SNOMED. This is an international set of clinical healthcare terminology for use in electronic health records.
SCTID: 1340196008
Persistent sexual dysfunction following withdrawal of selective serotonin re-uptake inhibitor (disorder)/
PSSD – post selective serotonin re-uptake inhibitor sexual dysfunction
While this is a positive step forward, it remains to be seen how beneficial it will be to patients. If you already have a supportive doctor who acknowledges that your condition is the result of previous antidepressant use, then the new SNOMED code offers a means of more formally recording your condition as PSSD in the medical notes. But if your doctor is dismissive and refuses to believe that your problem is anything other than a psychological issue, the availability of the new code might make little difference.
If your doctor has difficulty finding the SNOMED code, you can quote SCTID: 1340196008. Different medical practices may update their systems at different times, perhaps only a few times a year, so it’s possible that it may not be available for everyone yet.
There is also now a SNOMED code for protracted antidepressant withdrawal syndrome (disorder) – SCTID: 1285639002. It may be worth getting this into your medical record as well.
Orphanet
We were recently advised by a member of the PSSD community that their efforts had led to PSSD being recognised by Orphanet, an international organisation that specialises in rare diseases. He had spent a lot of time at this, and it’s quite an achievement to get them to recognise the condition.
It is worth clarifying that it isn’t known how many people fully recover their original sexual function after using serotonin reuptake inhibitors, and there is no robust data establishing that PSSD is rare, but it does qualify as rare in Orphanet terms. As discussed in our recently published journal article about PSSD epidemiology, the available data suggests the contrary.
One of the advantages of being listed in Orphanet is that it opens the door to getting rare disease research funding.
tim says
Thank you to all at RxISK, and other groups, who have worked with such absolute commitment resulting in such encouraging progress being reported this morning.
mary H. says
Thanks for the information shared here, David, which has raised a few questions in my mind.
As far as protracted withdrawal and PSSD are concerned, we should be concentrating on those people who are ( or have been) on an SSRI – is that correct?
Would you suggest that for PSSD, if one recognises him/herself as being in that group once they have followed your guidelines here, they should PERSONALLY send in a yellow card report – even if their GP refuses to acknowledge their suffering as being PSSD?
Is there a similar guideline that you could provide for protracted withdrawal? I would assume that your reply for the PSSD question would run true for this condition also?
Now to SNOMED – a short survey within our withdrawal groups found that areas are using the codes as such but needed support in finding these two particular ones. There was an explanation from one doctor that these codes are better known to their office staff rather than the doctor who sees the patient. To me, that would indicate a big problem – without the doctor being specifically aware of these new additions, their patient is hardly going to have the condition recognised in that surgery’s system. Is there anything we can suggest to overcome this?
Doctors seem to suggest that they have no time for getting the codes applied to their patient – surely, for any patient who qualifies for Benefits, having the SNOMED code should ease the doctor’s workload when it comes to completing their part of a Benefits Application Form?
We were pleasantly surprised to find that Wales ( here in the North anyway) understands the SNOMED codes – although unsure about their knowledge of these recent ones.
Our survey wasn’t in any way representative of the whole of the UK – simply pockets of it according to our contributors’ postcodes. Of the few that came back to us, those in the South of England are aware of them as is the Manchester area of the North. Further up north, they are aware but not yet fully operational. Scotland has a similar system in place, but doesn’t come under the SNOMED heading. That had previously also applied in Wales.
By the very nature of this survey, it was not essential to arrange an appointment with the GP as anyone within the surgery should have been able to provide an answer to the questions. This would have been possible by email if attending the surgery was not a possibility.
That leads me to another headache – the majority of our attendees were unable to carry out the survey in any of the suggested ways. This, in the main, was due to their present conditions being so overwhelming that they couldn’t entertain the thought of taking on anything extra to their daily, completely exhausting routine.
I feel that this leads us to a further fragmentation of support. Those who are well enough are able to suggest these changes to their surgeries – but what about the others? Are they going to be left behind yet again – due to being unable to tend to their own needs? Is there any perceived way that we could possibly put something in place to help this particular group? Having lost faith in their doctors, are they to be punished now for not being able to share this information with their surgeries?
This group, for sure, are not going to be able to put forward a case for their own possible suffering of PSSD or protracted withdrawal. They could so easily be pushed even further down the pecking order. Their chances of positivity seem slimmer than ever. There must, surely, be something that we can do for them? An advocate should be available but, there again, their link is to the system which has already repeatedly let them down. It is unlikely that the advocate will go against a doctor’s advice concerning a given patient’s condition. There lies another source of great unhappiness.
The Yellow Card System can be completed by the individual as we know, so the problem there would have more to do with their present situation – extent of symptom suffering etc. – so they would likely miss out on this also.
I would love to have some suggestion that we could share with our group to improve their feelings of inclusivity within the system. I appreciate, of course, that getting all who CAN go ahead with the suggestions will make a difference and that that is the overall purpose of your post. I have simply grabbed at the chance of shining a light on those for whom this suggestion is, at present, an impossibility.