Professor David Healy meets with the MHRA to talk SSRI withdrawal reactions

Notes of the 26 June 2009 meeting – thanks to Bob Fiddaman at Seroxat Sufferers.

I find it unbelievable that all too many GPs still know next to nothing about withdrawal reactions from SSRIs.

Prof Healy considered that there was little evidence available on how to manage patients who had difficulty withdrawing from SSRIs. All agreed that this was a very difficult area to study as the management of the patient would differ depending on the patient.” Maybe if the drug companies would start by admitting there is a problem we could begin to look for some answers.

Unfortunately all the drug companies take the same stance that Glaxo has with Seroxat/Paxil – problem, what problem??

Still, we should get some answers in the Autumn of 2010 – that’s when the High Court in London is scheduled to hear the start of the UK class action against Glaxo and Seroxat. I, for one, cannot wait to follow this trial and see all the secret documents that have been hidden from the public for so long by Glaxo.

Open Court – that’s what we want – let’s have everything out in the full glare of the world’s press.

Anyway – here are the notes from Prof Healy’s meeting with the MHRA:

Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants
Attendees:
Professor David Healy
Mrs Sarah Morgan
Dr Julie Williams
Ms Diane Leakey

1. Introductions and background
MHRA explained that the background to this meeting was a meeting held with Mr Fiddaman in September 2008. Mr Fiddaman had raised concerns about a lack of awareness on the part of health professionals of withdrawal reactions with SSRIs and related antidepressants. Prof Healy explained that he had had a long term involvement with the safety of SSRIs and that he received a large number of e-mails directly from people withdrawing from SSRIs asking for advice on management of withdrawal symptoms. Before the meeting Prof Healy had provided documents that he had produced relating to the management of withdrawal from SSRIs.

2. Existing advice on management of withdrawal reactions with SSRIs/SNRIs
All agreed that most health professionals get their information from guidelines issued by the National Institute for Health and Clinical Excellence (NICE) and the British National Formulary (BNF) rather than directly from the Summaries of Product Characteristics (SPC), although it was noted that the SPC was very important as it dictated the information that would be available to the patient through the Patient Information Leaflet. MHRA informed Prof Healy that they had provided input to the recent consultation for revision of the NICE depression guideline and that the revised guideline would be available towards the end of the year. MHRA had also informed the BNF that they were looking at the area of withdrawal reactions and would contact them in the future regarding proposals for updates to the relevant sections of the BNF. MHRA also raised the important role played by Prescribing Advisors in the Primary Care Trusts in influencing prescribing practice. Prof Healy said that a key point not included in the guidance currently available was the existence of liquid formulations of SSRIs which could be useful in the management of withdrawal to allow slow tapering. Prof Healy also stated that before treatment started there should be a discussion between the prescriber and the patient about the possibility of withdrawal reactions.

3. Awareness of withdrawal reactions in clinical community
Prof Healy expressed the view that general practitioners (GPs) were not aware that withdrawal reactions on stopping SSRIs could be prolonged in some patients and were not aware of how to manage withdrawal reactions in these patients. Prof Healy was concerned that GPs may instinctively advise patients to withdraw by taking tablets on alternate days and this was not an appropriate approach.

4. New evidence relevant to management of withdrawal reactions
Prof Healy was not aware of any new evidence relevant to the management of withdrawal reactions. When asked if he had a view on the size of the problem of serious and prolonged withdrawal reactions with SSRIs, Prof Healy said that this was not possible to measure. Prof Healy said that while the propensity of an SSRI to cause withdrawal reactions was often thought to be only related to the half-life of the
drug, this seemed unlikely to be the case – it could also be related to the potency of the different drugs at the serotonin reuptake site. The lack of understanding of the problem contributes to a lack of effective solutions.
MHRA asked whether in his view there was any way that patients who were more at risk of prolonged withdrawal reactions could be identified. Prof Healy said that he felt that from his experience women seemed to be more at risk than men but it was unknown whether this was because more women than men were treated with SSRIs. MHRA said that their review of the issue had not identified any link between the risk of withdrawal reactions and the gender of the patient. Prof Healy considered that there was little evidence available on how to manage patients who had difficulty withdrawing from SSRIs. All agreed that this was a very difficult area to study as the management of the patient would differ depending on the patient.

5. Dependence/withdrawal for women of child-bearing years
Prof Healy had asked for the issue of use of SSRIs in pregnancy to be included in the agenda. He said that it was an important issue and the subject of upcoming court cases in the USA. Prof Healy said that it was important that women of childbearing years were appropriately informed of the risk of withdrawal reactions with SSRIs before beginning treatment and stated that in his view doctors may be liable under the Congenital Disabilities Act 1976 if they did not adequately inform patients of the risks of treatment during pregnancy.
MHRA said there had been communications about a small risk of congenital malformations associated with paroxetine and this issue was under further discussion at EU level. Prof Healy highlighted a recent publication describing an animal study looking at reproductive toxicity of a variety of SSRIs. MHRA asked for the reference and to be kept informed of any further new evidence of relevance to this issue.
MHRA noted that NICE had published its antenatal and postnatal mental health: clinical management and service guidance and that it was important that NICE was kept informed of any new evidence or advice in this area. MHRA agreed to find out whether review of the guideline was planned and to let Prof Healy know the best contact point for communication on this issue. Post meeting note: Prof Healy confirmed post-meeting that he had contacted NICE on this issue.

6. Opportunities for better communication with health professionals
Prof Healy said that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes.

7. AOB
MHRA thanked Prof Healy for attending the meeting and agreed that it would be important to keep in contact on important new evidence in this area.

40 Responses to “Professor David Healy meets with the MHRA to talk SSRI withdrawal reactions”

  1. Sara Storer Says:

    I too am awiting the court case in 2010.My life is a living hell due to seroxat and the physicians lack of understanding of this drug class.I have been treated with so many SSRIs/ NEUROLOEPTICS my brain is all over the place

  2. Lynn Says:

    Hang in there. It is possible that your brain can heal at least enough for you to feel half normal again, although this can take years.
    Schema therapy might help, even though it was developed for something else.

  3. Sarah Stapley Says:

    Seroxat is t drug here but need help im on Venlafaxine (Efexor). Now clear my semi coma Somnolence iv had 7yrs now -tho dr never blieved) wz drug ‘not’ depression. Took mths to realise – im blacklisted! 6 Drs say im alcoholic drug user. Help?

  4. Lynn Says:

    I can only suggest that you try to get to a psychiatrist and join a support group. If you drink alcohol every day and are unable to stop, that may be contributing to your fatigue. You may want to get a general checkup and ask for help with a plan to detoxify yourself with the emotional support of some doctor-okayed group. You can ask the psychiatrist for help tapering off the Effexor. You have the right to quit a psychiatric drug, but you do need a doctor’s help. You may have to go along with a doctor calling you an addict in order for him or her to be willing to help you withdraw from the anti-depressant. There is withdrawal with these “medications”, and there is the occasional doctor who is starting to recognize this truth. It sounds to me like you need professional help and a lot of support. You may have to give up trying to make doctors understand how you know that Effexor has hurt you and just try to force yourself to accept whatever help they are psychologically able to provide. You do have to right to say that you would like support in getting off the Effexor, but most doctors cannot stand being told anything which contradicts their training and their own schema thinking. I don’t know what you mean by blacklisted, but doctors can’t legally refuse you a visit there, can they? I think a good next step would be to find some publically funded resource center and ask if there is a therapist you can sign up with. You might want to try to force yourself not to insist that Effexor is the only problem, especially if you do drink and take illegal drugs regularly. The therapist will not be able to hear it. I have found that being respectful and refraining from arguing with doctors and therapists eventually helps the occasional one relax and be willing to hear small, calm, factual descriptions of symptoms and seem more compassionate and willing to help. If you can refrain from pushing over several appointments or group sessions, you will develop credibility for your perceptions and interpretations. The biggest hurdles are holding your legitimate need for validation in abeyance, and trying to keep reminding yourself of the prize you may be able to get in the future if you stick with this plan, which is the help you actually want. Good luck.
    Lynn

  5. Sarah Says:

    dont drink & med recs show i bgan to take amphetamines ‘after’ Dr ignored my sleeping days at a time he insisted i admit my depression & refused to send me to specialist. Got another Dr to refer me recently, their ‘refering’ was
    ‘drinks, drugs & lazy’

  6. Sarah Says:

    Sorry my browser on fone is crap.. I got wyeths clinical trials for all’ treatments & somnolence is a v high ADR. Yet its not on PIls. I complaind about my Dr to manger at the practice. Since then iv been given wrong prescriptions. Even told ‘Go Away!’

  7. Sarah Says:

    Cont… This is dspite all other ADRs i have also. Im very ill tapered from 300mg-75mg alone (in aprox 11mths). Im a single mum (daughters 17) unable to get benefits cz Drs say i time wasting junkie! Its cruel, unjust & ilegal! Yet no £ for a lawyer.

  8. Lynn Says:

    I don’t understand the English medical system. Is there a mental health clinic in your city? Doctors and psychologists in the U.S. know that calling someone “lazy” is abusive, unhelpful, and an excuse for not helping people. A schema therapist would have a better chance of helping you than English doctors, apparently. The only thing I can think of, not being familiar with your medical system, is for you to try to see if there is a schema therapist anywhere near you. I am really sorry for what you are going through and that I cannot offer any other advice.

  9. Sarah Says:

    I know! but honestly thank & apreciate u having answered-the referral.. ‘she has a poor attendance at clinics uses drugs, is sound in time place & person, self harms non psychotic symptoms, non suicidal ‘hopefully’ she will be motivated to make

  10. Sarah Says:

    Cont.. Aptment? told dr about the hell of withdrawal (anger, harming myself & other v worrying behaviors) the referal says ‘she finds ‘if’ she reduces further ‘then’ gets side fx’ ì didnt think bout mental health help. Il check out! Thank u 🙂

  11. Lynn Says:

    Godd luck!🙂

  12. Lynn Says:

    Good luck, sorry!

  13. Sarah Says:

    Thank u! I failed DWP tribunal Mon, tho agreed i need medical help. The idiotic morons acknowledge my being alergic to the med im addicted to, without med help But deem me fit for work & stop my benefits (includes free efexor) maybe il b in the,.

  14. Sarah Says:

    Cont.. In a few weeks? I know some will view me ‘dramatic’ but i am festering on a low boil once im without ‘cold turkey’? … Im nauseas more with the thoughts at the moment, iv been violent already (during reduction) i dont want to do this anymore

  15. Lynn Says:

    Are they going to make you go off Effexor cold turkey?
    Is there any way to get tapering down prescriptions?
    Maybe if you can get a copy of The Antidepressant Solution by Joseph Glenmullen and give it to somebody, he or she will understand that you can’t go off this drug cold turkey.
    I went off Xanax cold turkey and attacked someone six days later. I was just lucky that I thought to tell the police that I had run out of my medicine and they took me to the hospital instead of arresting me.
    You really have to print something from a medical website about ssri withdrawal and ask the doctor you spoke to to read it. It sounds the people you just spoke to don’t understand how ssri’s work. You could kill yourself or someone else if you are not allowed to taper off the Effexor.
    I think you should force yourself to be as calm and polite as if your life depended on it, now matter how you feel. I know that that may be impossible, but if you have any strength left, please try. Your life may depend on being able to convince these people to give you tapering prescriptions and samples or coupons or something to buy them.
    This website might be persuasive to an intelligent medical person.
    www drglenmullen com/index_files/Page483.html
    I’m so sorry you’re having such a difficult time getting the help you need.
    Lynn

  16. Sarah Says:

    Thats the thing ive even handed over Prof David Healy statements, prof Taylor (Hospital Pharmacist) own account of withdrawal & more, but becz it truly was an error to hav ever put me on never mind upping the dose. Im now a big problem & it getting..

  17. Sarah Says:

    Cont.. Clearer (upon thinking it through) what an easy way to ‘rid’ & excuse the medicating me all this time. I hav decided to write letters to as many ppl as poss with what is going on. My view at mo. If anything good ‘can’ come from this? Then

  18. Sarah Says:

    Cont.. To expose everyone that hasnt bothered to listen & create a media scandal of the medication. If i write the letters now n await the last day of medication (cz hopin i ‘wil’ find help 1st) b4 sending, cz il kno i wont b taken seriously otherwise…

  19. Sarah Says:

    Cont.. Im unable to take it all in. Truly do not believe that 100s of 1000s of ppl know cz they going thru it yet the Dr.s dont! Im blacklisted negative referrals, prescription accident, fake generic! punished 4 complaining. ThanQ 4 talkin to me🙂

  20. Lynn Says:

    Maybe if you send the medical people an incredibly polite note promising not to sue them if they give you tapering down prescriptions, they might be willing to deal with the situation appropriately, instead of acting like they are suffering from guilt twisted into punishing anger. I think your idea of writing your account of the facts which have happened to you and then waiting to send it is a very good idea. I know that when I am heated, I write stuff that I wish I had not written later. I think people with prickly egos may possibly be able to give a little if they do not feel attacked or blamed. The more intense you get with trying to get people like this to listen to you, the more they want to turn away. I have found that I get the most apparent actual listening when I try to phrase things as factually as possible in a very quiet voice, without staring, and letting there be longish pauses between ideas. If you look like you are asking them something, instead of telling them to do something, they may calm down and get more professional. I have also found that writing something when I am upset and then reading it several times out loud helps me see the things which mean so much to me which some medical/psych people might claim is unbearably abrasive. A couple psych people I have met seemed to have as fragile egos and as easily offended and angered personalities as any mentally ill person I have met. When I go back to something I have written a couple days later, I often see things that I need to remove if I want the recipient to want to help me, and I think I have usually gotten a decent response, even when the person has been unable to give me what I want, and I can at least feel that I may have made a decent impression, so that the person will be willing to listen to me again in the future because I didn’t make him or her feel attacked. It is really difficult placating the egos of difficult doctors and counselors, but in my experience, it is the only way to have the ghost of a chance of getting what you need, and most med/psych people (in the U.S.) including phone staff really appreciate it when the patient/client tries to be incredibly calm and respectful, because apparently a lot of patients are abusive.
    Was the prescription accident with a new tapering dose? If you take the mistaken pills to your doctor and don’t accuse anyone of anything, just politely ask for him or her to call the pharmacy and ask for the prescription to be replaced, I ‘m sure your doctor or the office’s nurse will be happy to do that.

    I think that older doctors must be recognizing the personality changes that they have been witnessing in their ssri patients over the decades. They just have to be made to feel safe enough to admit it before this hell can be stopped.
    Lynn

  21. Sarah Says:

    I know what u mean, despite the fact Drs r ‘not’ in fact clued up about the medication (esp brain med!) they arrogantly believe being a Dr automatically gives ‘higher knowledge’ than the person taking it, regardless of my research (thorough! Med journals

  22. Sarah Says:

    Cont.. Clinical trials etc (clinical trials as everyone knows being v limited via lack of ‘full truths)’ i have in my posession Wyeths published trials of Efexor. My initial ADR ‘somnolence’ 7yrs ago (still have today along with countless others) was

  23. Sarah Says:

    Cont.. Mistaken 4 a relapse of depression (now know i shouldve never been medicated the 4yrs prior to the ADR, 2yrs unless ‘severe &/or manic depression’ i was only ever ‘down’ if anything) i dont care about the error truly! I care about how im being

  24. Sarah Says:

    Cont.. Treated bcz of it. I know what u r saying & u r right but to be heard is seemingly impossible. Whats more everytime ive asked for help & explained my situation (politely & acted dumb) i either get more screwed over or get wrong advice through total

  25. Sarah Says:

    Cont.. Ignorance. 1 dr told me u ‘cannot’ get withdrawal from Efexor. When i said i actually was going thru, he said Quote ‘well u shouldnt b trying to come off’ & ‘these medications can b taken indefinitely!’ UnQuote.. That was a few months ago. My

  26. Sarah Says:

    Cont.. Complaint wz to the manager of the Drs surgery to say my situation of ‘needing’ help to come off yet oddly could never get to see my Dr (always booked up when it came to me) she told him all i said & ive been screwed since. Called drug abuser etc

  27. Sarah Says:

    Cont.. The prescription was my medication with someone elses name on it. I got given (banned in USA- ‘Ranbaxy’) generic which made me so ill im Feb. They gave me it on Friday too. I caused a scene cz the chemist said Feb that hed do a yellow card (report)

  28. Sarah Says:

    Cont.. It ‘was’ a dif person (same chemist) both times the signed boxs wer not! & both times ‘sealed’ packets. They never seal just fold. I admit i take a little satisfaction in the fuss i kickt up bcz it threw them & theyve promist my usual generic

  29. Sarah Says:

    I am as u know out of benefit.. I have to pay. What with? So if im refused the medication wen i next go in? it will b less of a problem now to convince them the issue ‘im addicted!’ personally im avoiding the what im capable of when without them!😥

  30. Lynn Says:

    I’m sorry. I thought the U.K. government paid for healthcare. People who can’t work in the U.S. because of physical and mental health problems can apply for a government benefit. If you have no way of getting government help to pay for your next prescription, I guess all you can do is document everything you have gone through and send it to a newspaper so if something bad happens when you go through withdrawal, you will have proof of how badly the doctors and chemists treated you. I know that will not help you, but at least the truth can be known and maybe some authority can force medical people to improve their knowledge and treatment of people whose brains have been damaged by their prescriptions. I am so sorry. I guess I thought that the English system got citizens what they needed.
    Someone I know had such a bad time getting off Effexor that she had to count out grains from the capsules in order to reduce her withdrawal effects. Do you have enough pills left so that you can start tapering down now? It may be too sudden a withdrawal, but it might be less devastating to your brain than an abrupt drop in the levels, which is what Dr. Glenmullen says throws the brain into shock.
    I wish I could think of something more helpful.

  31. Sarah Says:

    U are helping truly. by talking to me, i know no-one who has been on the medication themselves. Read stories & accounts but never ‘spoken’ with anyone on the/similar drug nor anyone who really knows the ugliness of it all. I am with no benefit but so r

  32. Sarah Says:

    Cont.. Alot of ppl who cannot work its a huge scam to lower unemployment figures & a fake health company Atos r stating that being able to walk, talk bend n stretch makes u fit 4 work. Many ppl have had benefit re-instated at the tribunal but they do have

  33. Sarah Says:

    Cont.. D rs to back them. During the await 4 the tribunal Drs r supost to sign med certs so u can claim benefit. I had month of no £ (dec09-may10) bcz i had been signed a’dud’ med cert. My local MP helped me get ‘that’ information. I then had a legal

  34. Sarah Says:

    Cont.. Advisor ring the Dr on my behalf to obtain a med cert (the dud one stated i was awaiting tribunal it said nothing of my ‘mid reducing dose’ or in fact ‘any’ medical related text) i managed to get a 3mth backdated med cert wiv legal advisors help

  35. Sarah Says:

    Cont, Which i owed out from borrowing. But this was after they tried to giv me a 1mth 1st. It was on ‘that’ med cert the drug & alcohol abuse was written. It hurt to have to but desperate 4 benefit backdate-but that didnt cover anytime since (council tax

  36. Sarah Says:

    Cont.. Rent, health care. – uk call NHS free but a % of every working persons pay is taken for healthcare. I am researching so much the nhs is spending billions on brain meds. And then billions on brain med ADRs when they go wrong (hosp etc) but to put

  37. Sarah Says:

    Cont. A stop on it will b an admission & exposure of Wyeth, Glaxo etc & theyre too scared to do this despite saving lives (even £ in their case!!) isnt enuf! Im awaiting a Dr to come back off hol (he the senior Dr at the surgery -only found out recently

  38. Sarah Says:

    Cont.. Hes my only hope now. I wil go to the chemist tomorow to pick up the proper generic a friend has said if i faced with having to pay then he wil pay it. Despite all this i am blest wiv good ppl i wil never forget that. I wont b going cold turkey

  39. Sarah Says:

    Cont.. Just yet😀
    It givs me at least 1mth 2 try what i can regarding all of this. I truly will fight 2 the bitter end & yep exposure! if n wen i am left to go it without. If i have to? I will scream Drs names to the papers. Theyl wish theyd helped😥

  40. Lynn Says:

    I’m glad you have a month and another prescription. If your friend can help you pay, then you can probably make it through this.


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