I had a meeting early this month with senior staff and various experts from the MHRA to discuss the lack of informed consent and adequate patient safety warnings on antidepressant medication in the UK.

 

They seemed receptive to the points I raised. Below is a summary of each point (kept as brief as possible, as obviously discussion was very in depth), and the MHRA’s reaction.

 

I am awaiting further feedback from them on the meeting, including minutes. I will post further updates, however going via politics and large organisations does take time and persistence.

 

I also shared details of my experience, which they made considerable amounts of notes on.

 

There were a number of further points that I wished to raise, however I only had an hour. If I can keep the line of communication with them open, I intend to raise further points.

 

 

No warning about Protracted Withdrawal Syndrome in Patient Safety Leaflets

 

I raised that the PIL only includes advice not to stop abrupty, and that for Mirtazapine it also states “If you stop suddenly, you may feel sick, anxious or agitated and have headaches. It is possible that some of your symptoms may come back.”.

 

There is NO warning whatsoever of a serious, neurological syndrome which the RCPsych lists 27 symptoms for, and states that doctors cannot predict nor prevent it, and can last for years, with it’s own diagnostic codes etc and multiple patient voice surveys with hundreds of UK sufferers.

 

I stated that compared to other warnings about side effects, surely for patients what is far more important than incidental effects whilst taking a drug is a risk of years of long term harm, and questioned why there was no warning about this whatsoever.

 

I stated that at the very least PILs should include warnings that:

 

• Mirtazapine is a dependence-forming drug
  
• Before taking it, patients should be aware that there is a risk of severe and debilitating symptoms lasting many years after stopping it, significant enough to be a known syndrome with a diagnostic code.
  
• Doctors cannot predict this, and also cannot prevent it. Following advice of doctors is not enough to prevent it.
  

 

 

Dependence-Forming Drugs

 

I noted that in internal discussions about risks of antidepressants between the NHS, RCPsych and MHRA, antidepressants are described as “dependence-forming drugs”.

 

I then pointed out that nowhere in any patient-facing information anywhere on the NHS site, is information provided by doctors nor in the Patient Information Leaflets is the word dependence ever used.

 

I then stated that I could not consent to taking a dependence-forming drug.

 

 

Patient Information Leaflet Contains Scientifically Unsound Information

 

In the follow-up information provided after the meeting, I also pointed out that the PIL contains an explanation that antidepressants correct chemical imbalances in the brain, which was never objectively proven and is a position that psychiatry has since abandoned.

 

I questioned why such information would be present in the leaflet in the first place if it was not evidence-based and could easily mislead patients to believe that they had an objectively measurable chemical “need” for medication.

 

 

House of Commons Report

 

I raised a house of commons report done in the early 2000s: HC 42 I 04.05.pdf

 

I pointed the MHRA towards numerous quotes from it:

 

“During six previous investigations, user reports of often serious problems had been systematically discounted or ignored.”

“There was perhaps a degree of complacency in the Minister’s view of the Yellow Card Scheme. This system is widely considered to be failing and was described to us as “worthless” and “bit of a pup””

 

“Richard Brook, who was one of two lay members originally on the EWG examining SSRI antidepressants, told us: I seemed to be the lone voice on this expert committee saying, “This is of concern”, and the response I would get is from the Chairman or the officials, “Yes, this is very worrying, but it is going to have to be formally investigated”, and it seemed to go, in my view, into a black hole and remains there to this day despite questions on the floor of the House and questions elsewhere.”

 

“The suicidality problem was first investigated in 1990/1; withdrawal reactions were investigated in 1993, 1996 and 1998. In 2002, the MCA organised a further intensive review of both problems. This review was abandoned in April 2003, following criticism about conflicts of interest involving key figures on the review team.”

 

“The appointment of lay members was unprecedented; their contribution to the work of the EWG was subsequently warmly acknowledged. However, one of the two lay members left soon after the review began. The other was Richard Brook, the chief executive of Mind, who resigned in protest half way through. A third lay member was appointed to the EWG eight months later, by which time the report was virtually complete. In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action”

 

“The EWG was therefore unable to focus on its original brief, relating to withdrawal problems and possible suicidality in adults, until the end of 2003. Its final report identified a significant lack of important data, a clear and substantial risk of sometimes severe withdrawal reactions”

“There appears to have been a lack of effective warnings relating to the frequency of withdrawal symptoms experienced with Seroxat” “However, working papers seen by the EWG state that the original licence application recorded Seroxat withdrawal reactions in 30% of patients. The regulators denied this.”

 

“Three separate reviews conducted by the MCA/CSM in the 1990s were all based on Yellow Card counts, and produced misleadingly low estimates of the risk level”

 

“The MHRA/CSM failed to warn of the lack of evidence (since the early 1990s) of SSRI effectiveness in mild depression, suggesting that most users might expect minimal benefit when exposed to significant risks”

 

I questioned why, 20 years after establishing that there were serious risks and a lack of effective warnings, there are zero warnings about any of this for patients, and why I was able to suffer the exact same life-altering harm decades later.

 

 

Patient Voice Surveys

 

I pointed the MHRA towards two patient voice surveys:

 

Antidepressant Withdrawal: a Survey of Patients’ Experience by the All-Party Parliamentary Group for Prescribed Drug Dependence – 2018

 

The nature and impact of antidepressant withdrawal symptoms and proposal of the Discriminatory Antidepressant Withdrawal Symptoms Scale (DAWSS) – 2024

 

I then made the following points:

 

• Despite the MHRA justifying not providing any warnings with low yellow-card counts, researchers have no problem finding hundreds of people affected in the UK at any one time should they want to study this iatrogenic harm
  
• Many sufferers reported significant disability and suffering for years
  
• Mean number of symptoms experienced by sufferers was 19.1
  
  • NHS website only lists 7 symptoms
    
  • PIL doesn’t warn of a multi-year syndrome with many symptoms at all
    
  • NHS website just mentions in one line that some people may have severe symptoms that last “a lot longer”
    
  • Both of the NHS and RCPsych pages on stopping antidepressants are buried amongst general guidance on antidepressants.
    
  • The NHS page for side effects doesn’t mention protracted withdrawal syndrome at all and doesn’t directly link to anything about persistent harms despite it having a SNOMED code and the NICE guidelines specifically acknowledging it.
    

  [*]The information given and total lack of strong warnings is totally inadequate. Even if you’re specifically looking for it, it’s hard to find the single line of text that describes this condition having “severe symptoms for a year or more” which also itself understates the median durations in patient voice studies.

  [*]The same issues were reported in this more modern study as the ones highlighted in the APPG survey in 2018, highlighting that absolutely nothing is changing and that the NHS continues to do serious harm with no actions being taken to prevent nor mitigate it taken by them, nor the MHRA.

 

 

Patient-Facing Information Contains Zero Information on Risk

 

I pointed out that even though a “stopping antidepressants” guide by the RCPsych exists, patients aren’t aware of it nor that stopping them is dangerous.

 

I pointed out that BEFORE deciding to take them, patients need to know that they might struggle to stop them again, and that if they have an adverse reaction they may be stuck between two bad options of continuing to react adversely or being exposed to danger by stopping.

 

I pointed out that at the moment, finding this information relies on patients not trusting their doctor, and having a 6th sense to know that they should research that this particular drug might have lots of other information out there about risks of stopping it. Most drugs are not dangerous to stop, and most people would never think to randomly do this when starting antidepressants.

 

I stated that doctors MUST provide information that they’re dependence-forming and that they are risky to stop before a patient decides to take them.

 

I also pointed out that the dreadful treatment by doctors experienced by me, and many in the patient voice surveys was enabled by the complete lack of information provided to them about this risk and these harms, despite them being well-known by the MHRA and RCPsych and the subject of many internal discussions between them and the NHS.

 

 

Summary Points

 

• Providing no warnings to patients about known long term harms of treatment is indefensible and unethical after decades of them being known to every responsible organisation involved.
  
• All guidelines focus on how to stop, not warning patients in advance of taking these medicines that they can cause severe long term harms after stopping that doctors have no way to predict nor prevent.
  
• The overwhelming majority of these medicines are prescribed by GPs, who have no information on this topic and studies show will typically deny its existence and leave patients disabled and suffering if it happens.
  
• Inaction between patient voice surveys has resulted in the further disabling and suffering of hundreds more people in the UK, currently nothing is done to prevent another in a few years from displaying the same results. Every single one of those is a human being.
  

Good on you for doing this. What did the MHRA say to all this? 

 

Also it's a miracle that protracted withdrawal is even officially recognised now by the government via SNOMED.

For the most part, they made notes.

 

They agreed that the language around "dependence" needed review, and also that if there's a syndrome that lasts for years after with severe symptoms patients will want to know about that.

 

I'm not expecting anything to happen quickly. I have to go through my MP for this and even that takes a considerable amount of time.

 

I am also chasing other organisations such as the NHS and RCPsych but I'm not even sure my MP's office sent the documentation I wanted them to in June.

 

The main feedback that the MHRA provided is that making yellow card reports is absolutely vital, as they need to get good information on this issue. I encounter a lot of resistance trying to get people to do this.

Update:

 

I have received quite a lot of material from the MHRA, including meeting minutes which will help me to put better detail here as it recorded most of what was said and what points were raised. I woke up at 3:30am and travelled to London with a lot of physical difficulty that day so it is good that someone was taking minutes full time, as my memory of everything said might not be perfect.

 

I'm not sure when, but at some point I will update, or potentially even totally edit this thread in line with the minutes, and the next steps. I haven't had a chance to go through all of the material yet.

 

I may also lock this thread to comments, and put a separate "activism discussion, questions and suggestions" thread as I have done in the guides section, just so that each thread is a concise record of what's been said and done, with clear information, and can be updated to remain that way in line with discussions that happen elsewhere.

Hi, @Luke

 

Re: MHRA (Medicines and Health Care Products regulatory agency)

 

Did you get the impression that they did not know about the syndrome? You said that they agreed that “if” there were a syndrome that lasts for years, patients would want to know about that. Was there a question whether this syndrome exists or were they completely silent on the issue?

What are yellow cards? Could you fill us in on that matter? How do they work, if you know. Did they bring up the yellow card issue during your testimony? Thanks.

🧚🏻‍♀️Rosetta

9 hours ago, Rosetta said:

Did you get the impression that they did not know about the syndrome? You said that they agreed that “if” there were a syndrome that lasts for years, patients would want to know about that. Was there a question whether this syndrome exists or were they completely silent on the issue?

 

They were well aware that withdrawal reactions exist and can last years, and were aware of:

• A House of Commons report from 2004 highlighting these risks and previous failures to address them
• Recent patient voice studies highlighting multi-year recovery trajectories and symptoms etc. 

9 hours ago, Rosetta said:

What are yellow cards? Could you fill us in on that matter? How do they work, if you know.

 

They are reports of adverse reactions and harm done by medicines in the UK, made to the MHRA:

Yellow Card | Making medicines and medical devices safer

 

The MHRA collects and publishes statistics on these reports:

What is being reported | Making medicines and medical devices safer

 

9 hours ago, Rosetta said:

Did they bring up the yellow card issue during your testimony? Thanks.

 

Yes. We had a fairly long discussion about the difference between figures published in response to parliamentary questions, and the actual statistics. They provided an answer, I was not convinced by it.

 

They also explained why I had not received a response to multiple enquiries. There's not a lot I can do about that.

 

They also stated:

• Staff manually read the accompanying text with reports and add symptoms to databases if they're not already there from the more rigid selections and to look for trends
• They are aware that yellow cards are a fraction of the harm done, but it is very difficult to extrapolate this from very low report numbers. Everyone harmed by these drugs in the UK really needs to report it.
• Those who have reported a long time ago but are still suffering ideally should email or similar with their report number with updates, so the MHRA can see that people are taking a long time to recover- I have done this. They need to balance getting data with not harassing people. They are working on an online portal which would allow for better case tracking and updating your own reports etc.

 

Separately to yellow cards, there is a review of antidepressant risks going on at the moment in the UK. They want to have another meeting with me later in the year to get my take on any proposed outcomes of this.

Thank you so much for your work. I am in the USA, and we seem to be behind Europe in all things pharma. But, the existence of OUTRO is a good sign for us.

16 hours ago, Luke said:

They want to have another meeting with me later in the year to get my take on any proposed outcomes of this.

Thanks for the answers to my questions and for the making the effort to meet with them considering how ill you feel.  I hope you have a long window soon. 
 

🧚🏻‍♀️Rosetta

22 hours ago, mars said:

Thank you so much for your work. I am in the USA, and we seem to be behind Europe in all things pharma. But, the existence of OUTRO is a good sign for us.

 

It's marginally better in that it is being talked about and some recognition of harms is gradually appearing.

 

Other than that, we hand them out to millions with no regard for the consequences and the overwhelming majority of practitioners outright dismiss any possibility of adverse reactions, as proven by a multitude of patient voice studies.

 

8 hours ago, Rosetta said:

Thanks for the answers to my questions and for the making the effort to meet with them considering how ill you feel.  I hope you have a long window soon. 
 

🧚🏻‍♀️Rosetta

 

No problem, thank you.

I am scheduled to provide feedback on current UK warning labels on antidepressant drugs in the UK as part of the MHRA's review of them. I do not know who else is contributing, but I am aware that they are seeking feedback from other patients, and also "experts".

I will not have massive amounts of time, and it is focused mainly on this topic above, so I must try to keep things focused, but they do also want feedback on the patient experience, things like whether doctors had any knowledge and so on.

I currently plan to raise the following points:

• Warning labels make absolutely no mention that withdrawal syndrome can last for many years and cause a large list of severe symptoms after stopping the drug and that clinicians cannot predict nor prevent this.

• The above is despite the RCPsych having a ranking list of drugs most likely to cause this whilst saying it cannot be accurately predicted nor prevented, there being guidelines slowly being developed to try to prevent it, and there being an NHS clinic to try to deal with the harms these drugs have done to people.

• My experience precisely follows the large patient surveys done in the UK, in which hundreds of people stated that they'd been disabled by these drugs and that doctors had no knowledge of this, actively caused further harm and were often hostile.

• The RCPsych is developing guidelines, and so are other organisations, that recommend tapering in tiny steps. Currently the recommendation is that patients do this themselves DIY, which is utterly unacceptable. The pharmaceutical industry MUST be forced to provide doses for tapering and make them widely available on the NHS.

• Dose accuracy standards mandated by the MHRA are wider than the steps patients are supposed to DIY taper by.

I would welcome any feedback on the points I plan to raise, or whether any others are worth considering. Please keep in mind that there is SO much more I could say if I had hours, but I don't, so unfortunately I must be quite selective and focus on UK policy and guidelines and how they should change.

I am currently due to provide this feedback to the MHRA in October.

Hi Luke, is there scope to mention the ADRs that last for years and the kindling effects that are cumulative of coming off and back on?

Oh, and I also plan to mention that messaging around these drugs in the UK that I took the drug on the basis of has largely been false. At the time I took Mirtazapine:

• NHS material was full of repeat statements that "antidepressants are safe and effective" which have now been withdrawn. They were never based on good evidence. Why have pharmaceutical companies been allowed to push marketing statements such as this in clinical information?

• The information label in my Mirtazapine stated that it works by correcting a chemical imbalance in the brain. There has never been enough evidence to meet an acceptable threshold to include this in a factual information leaflet in the box. It is now an entirely abandoned theory. How did pharmaceutical industry marketing with no evidence make it into patient information?

On 9/7/2026 at 5:43 PM, SparklingG said:

Hi Luke, is there scope to mention the ADRs that last for years and the kindling effects that are cumulative of coming off and back on?

Potentially yes, what do you think I should say about this? I could perhaps roll it into my first point and say that I'm in touch with multiple individuals who have experienced a similar, multi-year syndrome from individual or a small number of doses which is totally at odds with the messaging that withdrawal scales with dependency. Does that sound appropriate?

On 12/18/2025 at 12:53 PM, Luke said:

I had a meeting early this month with senior staff and various experts from the MHRA to discuss the lack of informed consent and adequate patient safety warnings on antidepressant medication in the UK.

 

They seemed receptive to the points I raised. Below is a summary of each point (kept as brief as possible, as obviously discussion was very in depth), and the MHRA’s reaction.

 

I am awaiting further feedback from them on the meeting, including minutes. I will post further updates, however going via politics and large organisations does take time and persistence.

 

I also shared details of my experience, which they made considerable amounts of notes on.

 

There were a number of further points that I wished to raise, however I only had an hour. If I can keep the line of communication with them open, I intend to raise further points.

 

 

No warning about Protracted Withdrawal Syndrome in Patient Safety Leaflets

 

I raised that the PIL only includes advice not to stop abrupty, and that for Mirtazapine it also states “If you stop suddenly, you may feel sick, anxious or agitated and have headaches. It is possible that some of your symptoms may come back.”.

 

There is NO warning whatsoever of a serious, neurological syndrome which the RCPsych lists 27 symptoms for, and states that doctors cannot predict nor prevent it, and can last for years, with it’s own diagnostic codes etc and multiple patient voice surveys with hundreds of UK sufferers.

 

I stated that compared to other warnings about side effects, surely for patients what is far more important than incidental effects whilst taking a drug is a risk of years of long term harm, and questioned why there was no warning about this whatsoever.

 

I stated that at the very least PILs should include warnings that:

 

• Mirtazapine is a dependence-forming drug
  

• Before taking it, patients should be aware that there is a risk of severe and debilitating symptoms lasting many years after stopping it, significant enough to be a known syndrome with a diagnostic code.
  

• Doctors cannot predict this, and also cannot prevent it. Following advice of doctors is not enough to prevent it.
  

 

 

Dependence-Forming Drugs

 

I noted that in internal discussions about risks of antidepressants between the NHS, RCPsych and MHRA, antidepressants are described as “dependence-forming drugs”.

 

I then pointed out that nowhere in any patient-facing information anywhere on the NHS site, is information provided by doctors nor in the Patient Information Leaflets is the word dependence ever used.

 

I then stated that I could not consent to taking a dependence-forming drug.

 

 

Patient Information Leaflet Contains Scientifically Unsound Information

 

In the follow-up information provided after the meeting, I also pointed out that the PIL contains an explanation that antidepressants correct chemical imbalances in the brain, which was never objectively proven and is a position that psychiatry has since abandoned.

 

I questioned why such information would be present in the leaflet in the first place if it was not evidence-based and could easily mislead patients to believe that they had an objectively measurable chemical “need” for medication.

 

 

House of Commons Report

 

I raised a house of commons report done in the early 2000s: HC 42 I 04.05.pdf

 

I pointed the MHRA towards numerous quotes from it:

 

“During six previous investigations, user reports of often serious problems had been systematically discounted or ignored.”

“There was perhaps a degree of complacency in the Minister’s view of the Yellow Card Scheme. This system is widely considered to be failing and was described to us as “worthless” and “bit of a pup””

 

“Richard Brook, who was one of two lay members originally on the EWG examining SSRI antidepressants, told us: I seemed to be the lone voice on this expert committee saying, “This is of concern”, and the response I would get is from the Chairman or the officials, “Yes, this is very worrying, but it is going to have to be formally investigated”, and it seemed to go, in my view, into a black hole and remains there to this day despite questions on the floor of the House and questions elsewhere.”

 

“The suicidality problem was first investigated in 1990/1; withdrawal reactions were investigated in 1993, 1996 and 1998. In 2002, the MCA organised a further intensive review of both problems. This review was abandoned in April 2003, following criticism about conflicts of interest involving key figures on the review team.”

 

“The appointment of lay members was unprecedented; their contribution to the work of the EWG was subsequently warmly acknowledged. However, one of the two lay members left soon after the review began. The other was Richard Brook, the chief executive of Mind, who resigned in protest half way through. A third lay member was appointed to the EWG eight months later, by which time the report was virtually complete. In evidence to this Committee, Mr Brook expressed concerns about the influence of the industry on drug regulation, specifically the perceived threat by MHRA staff of legal entanglement resulting from regulatory action”

 

“The EWG was therefore unable to focus on its original brief, relating to withdrawal problems and possible suicidality in adults, until the end of 2003. Its final report identified a significant lack of important data, a clear and substantial risk of sometimes severe withdrawal reactions”

“There appears to have been a lack of effective warnings relating to the frequency of withdrawal symptoms experienced with Seroxat” “However, working papers seen by the EWG state that the original licence application recorded Seroxat withdrawal reactions in 30% of patients. The regulators denied this.”

 

“Three separate reviews conducted by the MCA/CSM in the 1990s were all based on Yellow Card counts, and produced misleadingly low estimates of the risk level”

 

“The MHRA/CSM failed to warn of the lack of evidence (since the early 1990s) of SSRI effectiveness in mild depression, suggesting that most users might expect minimal benefit when exposed to significant risks”

 

I questioned why, 20 years after establishing that there were serious risks and a lack of effective warnings, there are zero warnings about any of this for patients, and why I was able to suffer the exact same life-altering harm decades later.

 

 

Patient Voice Surveys

 

I pointed the MHRA towards two patient voice surveys:

 

Antidepressant Withdrawal: a Survey of Patients’ Experience by the All-Party Parliamentary Group for Prescribed Drug Dependence – 2018

 

The nature and impact of antidepressant withdrawal symptoms and proposal of the Discriminatory Antidepressant Withdrawal Symptoms Scale (DAWSS) – 2024

 

I then made the following points:

 

• Despite the MHRA justifying not providing any warnings with low yellow-card counts, researchers have no problem finding hundreds of people affected in the UK at any one time should they want to study this iatrogenic harm
  

• Many sufferers reported significant disability and suffering for years
  

• Mean number of symptoms experienced by sufferers was 19.1
  

  • NHS website only lists 7 symptoms
    

  • PIL doesn’t warn of a multi-year syndrome with many symptoms at all
    

  • NHS website just mentions in one line that some people may have severe symptoms that last “a lot longer”
    

  • Both of the NHS and RCPsych pages on stopping antidepressants are buried amongst general guidance on antidepressants.
    

  • The NHS page for side effects doesn’t mention protracted withdrawal syndrome at all and doesn’t directly link to anything about persistent harms despite it having a SNOMED code and the NICE guidelines specifically acknowledging it.
    

  [*]The information given and total lack of strong warnings is totally inadequate. Even if you’re specifically looking for it, it’s hard to find the single line of text that describes this condition having “severe symptoms for a year or more” which also itself understates the median durations in patient voice studies.

  [*]The same issues were reported in this more modern study as the ones highlighted in the APPG survey in 2018, highlighting that absolutely nothing is changing and that the NHS continues to do serious harm with no actions being taken to prevent nor mitigate it taken by them, nor the MHRA.

 

 

Patient-Facing Information Contains Zero Information on Risk

 

I pointed out that even though a “stopping antidepressants” guide by the RCPsych exists, patients aren’t aware of it nor that stopping them is dangerous.

 

I pointed out that BEFORE deciding to take them, patients need to know that they might struggle to stop them again, and that if they have an adverse reaction they may be stuck between two bad options of continuing to react adversely or being exposed to danger by stopping.

 

I pointed out that at the moment, finding this information relies on patients not trusting their doctor, and having a 6th sense to know that they should research that this particular drug might have lots of other information out there about risks of stopping it. Most drugs are not dangerous to stop, and most people would never think to randomly do this when starting antidepressants.

 

I stated that doctors MUST provide information that they’re dependence-forming and that they are risky to stop before a patient decides to take them.

 

I also pointed out that the dreadful treatment by doctors experienced by me, and many in the patient voice surveys was enabled by the complete lack of information provided to them about this risk and these harms, despite them being well-known by the MHRA and RCPsych and the subject of many internal discussions between them and the NHS.

 

 

Summary Points

 

• Providing no warnings to patients about known long term harms of treatment is indefensible and unethical after decades of them being known to every responsible organisation involved.
  

• All guidelines focus on how to stop, not warning patients in advance of taking these medicines that they can cause severe long term harms after stopping that doctors have no way to predict nor prevent.
  

• The overwhelming majority of these medicines are prescribed by GPs, who have no information on this topic and studies show will typically deny its existence and leave patients disabled and suffering if it happens.
  

• Inaction between patient voice surveys has resulted in the further disabling and suffering of hundreds more people in the UK, currently nothing is done to prevent another in a few years from displaying the same results. Every single one of those is a human being.
  

I just read this whole thing and i want to thank you for doing this!

Edited September 10Sep 10 by Some0n3

Thank you.

The best way to thank me, is to report your adverse reaction to the relevant authorities in your country. Reporting numbers are shockingly low and I repeatedly get pushback when I ask people to.

If the thousands and thousands of people who suffered harm from these drugs reported it, it wouldn't be ignorable.

Any feedback on any of this?