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| Heather Simmonds, Director | |
| Prescription Medicines Code of Practice Authority | |
| 12 Whitehall | |
| London SW1A 2DY | 20 May 2002 |
Dear Mrs Simmonds,
We wish to make a formal complaint under the Code of Practice for the Pharmaceutical Industry about statements relating to the safety of Seroxat (paroxetine, GlaxoSmithKline) made on behalf of the company by Mr. Alan Chandler, Director of Corporate Media UK. In considering this case, we ask the Code of Practice Authority to take into account the circumstances and outcome of our previous complaint about this company – Case AUTH/IFPMA/5/7/01 Statements about Paxil (IFPMA Reference C2001101) – which related to comparably misleading statements made about the same drug.
1. In an article by Anastasia Stephens in The Independent of 1st October 2001, Mr Chandler was reported as saying (of paroxetine and other SSRIs) "There’s no reliable scientific evidence to show they cause withdrawal symptoms or dependency." I telephoned him on 3rd October to ask if he had been accurately quoted. He confirmed he had: "Absolutely, Anastasia reported exactly what I said". I then wrote to Mr Chandler, asking him to substantiate his statement, "by reference to any authoritative body of opinion in agreement with you – or failing that, by any medically qualified person within GlaxoSmithKline PLC"
Mr Chandler replied on 17 October 2001, simultaneously stating that he was not referring to withdrawal symptoms, but had been accurately quoted. He claimed he had been quoted out of context, but that this "is not the fault of the journalist as she was covering a complex situation." This contradicted his earlier statement that he had been accurately quoted, but we did not pursue the issue, as Social Audit was then engaged in the aforementioned complaint against GSK’s Dr David Wheadon, who had claimed that withdrawal reactions from paroxetine were ‘very rare’. We did produce Mr Chandler’s statement and response at the Appeal Board hearing, but no adjudication was involved.
2. We would have left it at that, had we not seen reported comments of the same general kind, attributed to Mr Chandler, reported by Catherine Jackson (Editor) in an article in the April 2002 issue of Mental Health Today: "You have a product that’s been available for over ten years and has benefited tens of millions of patients. As more patients use the product globally you are bound to get these reports of bizarre side effects," says Alan Chandler, director of Corporate Media UK. "There is no scientific evidence that Seroxat leads to addiction and dependency. There have been one or two reports of discontinuation symptoms with abrupt cessation, which is why our data sheets [doctor and patient information leaflets] reflect new advice to taper off the medication. The data sheet is a living document and as usage of the product increases the labelling reflects the current usage experience"
I wrote to Mr Chandler again, on 7 April 2002, asking him to confirm he had been accurately quoted. Three weeks later, I wrote again with the same request, as I had received no response. Mr Chandler replied on 3rd May. He declined either to confirm or deny the remarks attributed to him. It was open to him to deny he would ever have said anything like, "there have been one or two reports of discontinuation symptoms with abrupt cessation", but he did not. That statement is misleading and unacceptable – for reasons explained and amply documented in our earlier complaint. As Mr Chandler knew, or ought to have known, withdrawal reactions indicative of dependence have been reported with paroxetine (e.g. to the WHO Centre at Uppsala and to the Medicines Control Agency) more than any other drug.
3. The statements complained of clearly violate Article 7 of the WHO Ethical Criteria – "…. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks …." These statements also fall short of the requirements of the IFPMA Code: "Information must be provided with objectivity, truthfulness and in good taste … accurate, fair and objective and presented in such a way as to conform … to high ethical standards" (I.2) … based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression (I.3) …"
We have previously supplied both the Authority and the Company with evidence of our concerns relating to the nature, extent and severity of withdrawal symptoms and dependence with paroxetine – in particular, the monograph (Medawar, 1997) published in the International Journal of Risk and Safety of Medicine and the further evidence reported (1997-2001) on our website, The Antidepressant Web. However, we outline below the facts that persuade us that the Company is in breach of several provisions of the ABPI Code of Practice, under which this complaint is made.
3.2 "The promotion of a medicine must be in accordance with the terms of its marketing authorization and must not be inconsistent with the particulars listed in its summary of product characteristics"
The statement, "There have been one or two reports of discontinuation symptoms with abrupt cessation" – especially in the context of a reference to tens of millions of satisfied users – is tantamount to claiming that withdrawal reactions are very rare (traditionally, <1:10,000). Though the Summary of Product Characteristics does not put a figure on the incidence, all available evidence indicates this is a grotesquely misleading under-estimate. The EMEA/CPMP position paper published in April 2000, acknowledged that withdrawal reactions were "well-recognised." They also stated that the term 'withdrawal reactions' should be used, not 'discontinuation reactions' as has been proposed by some marketing authorisation holders". The incidence of withdrawal reactions reported in the US label since modification by the FDA in late 2001 is greater than 1:100 and should therefore be described as "common". The implication that withdrawal symptoms occur only with "abrupt cessation" is unwarranted.
7.2 "Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all evidence and reflect that evidence clearly. They must not mislead either directly or by implication."
Mr. Chandler’s statement that, "there is no scientific evidence that Seroxat leads to addiction and dependency" is not inconsistent with the SPC. But we contend it is unfair, ambiguous and misleading, all the more so as a statement directed to a lay readership. The assertion that paroxetine is not a drug of dependence relies on [a] the lack of evidence to which EMEA/CPMP referred; and [b] a studiedly narrow and inappropriate interpretation of the definition in the 10th edition of the International Classification of Diseases. See Appendix One.
Since publication of the ICD-10 guidelines, the World Health Organisation (1998) has published a statement on "Selective serotonin reuptake inhibitors and withdrawal reactions," which makes it clear: [a] that dependence should be regarded as not an ‘on or off’ phenomenon, but as a condition that should be measured by degree; [b] that on existing definitions, sensibly interpreted, SSRIs can and do cause ‘dependence’; and [c] that in the last analysis, the patient’s experience with the drug is the test of whether or not a drug causes dependence:
"There is obviously some confusion about the concept of dependence ... The simplest definition of drug dependence given by WHO is 'a need for repeated doses of the drug to feel good or to avoid feeling bad' (WHO, Lexicon of alcohol and drug terms, 1994). When the patient needs to take repeated doses of the drug to avoid bad feelings caused by withdrawal reactions, the person is dependent on the drug. Those who have difficulty coming off the drug even with the help of tapered discontinuation should be regarded as dependent, unless a relapse into depression is the reason for their inability to stop the antidepressant medication.
In general, all unpleasant withdrawal reactions have a certain potential to induce dependence and this risk may vary from person to person. Dependence will not occur if the withdrawal symptoms are so mild that all patients can easily tolerate them. With increasing severity, the likelihood of withdrawal reactions leading to dependence also increases …" (WHO Drug Information, 1998)
Referring specifically to Mr. Chandler’s comment that, "there have been one or two reports of discontinuation symptoms with abrupt cessation", we refer to the published evidence cited in our previous complaint. We accept the point made in the EMEA/CPMP review (1999) that, "strong evidence which would allow definitive statements about the frequency of withdrawal reactions with the different SSRIs, is not available." However, investigators have consistently reported an incidence of withdrawal problems far greater than the incidence proposed by GlaxoSmithKline. Typical figures are 3/6 cases (50%) reported by Barr et al (1994); 5/13 - 38.5% (Keuthen et al, 1994); 10/50 - 20% (Coupland et al 1996); and 5/12 - 41.6% (Bhaumik & Wildgust, 1996). One recent review concluded as follows:
"In summary, with several ‘newer’ antidepressants, including, sertraline, paroxetine and venlafaxine, abrupt discontinuation after a moderate length of treatment leads to at least 1 out of 3 patients spontaneously reporting one or more discontinuation symptoms. Higher rates are reported when information on symptoms is solicited and in one study (Rosenbaum et al, 1998) approximately 2 out 3 paroxetine and sertraline recipients fulfilled criteria for a discontinuation syndrome. " (Haddad, 2001)
In addition to the aforementioned study by Rosenbaum at el (1998), we refer to the study reported by Oehrberg and associates (1995); the correspondent in the published paper is identified as Dr R Judge from SmithKline Beecham Pharmaceuticals, Harlow. The investigators reported: "… only 19 patients out of 55 (34.5%) who had received paroxetine reported any adverse event on discontinuation, as compared with seven out of 52 (13.5%) on placebo.
This trial is especially significant because GlaxoSmithKline indicated in response to our previous complaint (letter of 14 August 2001) that its estimate of the incidence of withdrawal reactions was substantially based on the finding that only 7 patients out of the 8,143 on its clinical trials database were reported to have experienced a withdrawal syndrome. Apart from the fact that the design of many trials on the SKB database (number unknown, but believed to be the large majority) would positively obscure evidence of the nature, incidence and severity of withdrawal - the number of patients experiencing withdrawal reactions in this one trial reported by Oehrberg and associates is over twice the number on the whole SKB clinical trials database. Not only was this trial excluded from the Company database, but it also signals an incidence of withdrawal reactions far in excess of the low levels the company implicitly claims.
Nor can the assertion that withdrawal symptoms are very rare (<1:10,000) be reconciled with evidence from spontaneous reporting. However troublesome the interpretation of these data may be, the major confounding factor is under-reporting. Yet by September 2001, the Committee on Safety of Medicines had received 1,242 reports of withdrawal reactions to paroxetine – a far higher number than for any other drug on the ADROIT database. The prominence of paroxetine in the ADROIT tabulation is underlined by the analysis by Price and colleagues in the Medicines Control Agency/Committee on Safety of Medicines: "withdrawal reactions with paroxetine constitute a greater proportion of reports (5.1%) than with the other SSRIs (0.06-0.9%). (Price et al, 1996)
The same picture emerges from the data generated by the Uppsala Monitoring Centre (27 January 2001), which has operational responsibility for the WHO's Programme for International Drug Monitoring. The table below identifies drugs on the Centre's database that have attracted most reports of withdrawal problems indicative of dependence. By a wide margin, paroxetine tops this list.
DRUG NAME |
REPORTS |
| Paroxetine | 2003 |
| Venlafaxine | 1058 |
| Alprazolam | 842 |
| Sertraline | 585 |
| Hyoscine | 519 |
| Fenfluramine | 450 |
| Fluoxetine | 402 |
| Tramadol | 389 |
| Phentermine | 371 |
| Methadone | 316 |
| Lorazepam | 282 |
| Dexfenfluramine | 277 |
| Diazepam | 192 |
| Triazolam | 188 |
| Clonazepam | 112 |
We further object to the statement that, "there have been one or two reports of discontinuation symptoms with abrupt cessation", on the grounds that SmithKline Beecham has known for many years that the frequency of withdrawal symptoms was likely to be substantial, following studies on healthy volunteers, carried out in the 1980s: "On average about half the volunteers taking part in a group of studies specifically designed to detect withdrawal problems suffered symptoms which suggest they had become physically dependent on the drug" (Boseley, 2001). The source of this information was Dr David Healy, who had personally examined this documentation in discovery relating to a US court case. Healy (2001) reported his concerns to the Medicines Control Agency, indicating that the results of these studies showed "withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines".
The further implication of the statement complained of is that withdrawal symptoms exist only when there is abrupt cessation of treatment. In our previous complaint, we requested the company to produce such relevant evidence as it had to support this assertion, but it did not respond. We have no problem accepting that gradual reduction of dosage may attenuate withdrawal problems, but clearly it does not abolish them. Gradual tapering of dosages had been employed in the three cases reported by Barr et al; in four of the five cases reported by Keuthen et al; and "the majority of cases occurred despite slowly tapered withdrawal" in the series reported by Coupland et al. See also CADRMP, 1998; DTB, 1999, below). Referring to the practice of dose tapering on cessation of treatment, on recent review concluded: "as yet there is no controlled data to recommend its effectiveness, the length of time over which it should occur or the minimum dose that one should taper to" (Haddad, 2001).
7.9 "Information and claims about side effects must reflect available evidence or be capable of substantiation by clinical experience …"
We rely on the arguments and evidence set out above. We also invite the company to inspect the 1000-odd spontaneous reports from SSRI users on the Social Audit website, the large majority of which relate to (a) withdrawal and dependence problems with paroxetine (Paxil, Seroxat, Aropax) rather than other SSRIs; and (b) reactions that are unexpectedly severe, disabling and often intensely disturbing. Our website is only one of several where users so complain. We submit that such a volume of reports, describing severe problems of a kind that manufacturers routinely deny and of which many prescribers appear unaware, can and should be considered "available evidence" within the meaning of the Code. We submit in support of this complaint a selection of comments posted on our website relating to users’ experience of dependence of paroxetine; see Appendix Two.
20.2 "Information about medicines made available to the public .. must be … presented in a balanced way … and must not … be misleading with respect to the safety of the product"
We rely on the arguments and evidence set out above, drawing attention also to the following Supplementary Information in the Code: "Particular care must be taken in responding to approaches from the media to ensure that the provisions of this clause are upheld.
2. "Activities or materials associated with promotion must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry.
We recognise that the Authority regards a ruling of a breach under Clause 2 as a sign of particular censure, to be used sparingly. We nevertheless request that a breach under this provision be ruled, taking into account:
In relation to this last point, we emphasise that the users’ comments attached in Appendix II are representative of recurrent themes: many prescribers are not aware of the significance of withdrawal and dependence problems (Young & Currie, 1997); users are not often warned about the possibility of withdrawal effects and dependence; prescribers are often unaware of the risks of mistaking withdrawal symptoms for ‘relapse’ and sometimes reluctant to accept patients’ accounts of withdrawal symptoms, causing considerable distress; patients unable to discontinue medication are obliged to resume drug taking, much against their free will; withdrawal effects may be extremely distressing and disabling; and withdrawal and post-withdrawal effects are reported to be worse than the condition for which the drug was prescribed.
For the record, and in support of this complaint, we are again enclosing a copy of our monograph (Medawar, 1997). Please let me know if you require any further information. We look forward to hearing from you.
| Yours sincerely, |
| Charles Medawar |
References
ADROIT: Medicines Control Agency drug analysis print for paroxetine dated 12/09/01.
L.C. Barr, W.K. Goodman, L.H. Price, Physical symptoms associated with paroxetine discontinuation (letter). Am J Psychiatry 1994 Feb, 151 (2), 289.
S. Boseley: Murder, suicide. A bitter aftertaste for the ‘wonder’ depression drug, The Guardian, 11 June, 2001. See: http://www.guardian.co.uk/Archive/Article/0,4273,4201752,00.html
S. Bhaumik, H.J. Wildgust, Treatment outcomes including withdrawal phenomena with fluoxetine and paroxetine in patients with learning disabilities suffering from affective disorders (Letter), Human Psychopharmacology, 1996, 11, 337-338.
N.J. Coupland, C.J. Bell, Serotonin Reuptake Inhibitor Withdrawal, J. Clin. Psychopharmacol., 1996, 16, 3, 356-362
S. C. Dilsaver, Antidepressant withdrawal syndromes: phenomenology and pathophysiology, Acta Psychiatr. Scand., 1989, 79, 113-117.
EMEA/CPMP: Position Paper on Selective Serotonin Uptake Inhibitors (SSRIs) and Dependency/Withdrawal Reactions, EMEA/CPMP/2775/99, (London: European Medicines Evaluation Agency, Committee on Proprietary Medicinal Products, 12 April, 2000).
FDA: labelling changes for Paxil, approved 28 September 2000, posted 16 November 2000 at http://www.fda.gov/medwatch/safety/2000/sep00.htm#paxil
P. Haddad, Antidepressant discontinuation syndromes, Drug Safety, 2001, 24(3), 183-197.
International Federation of Pharmaceutical Manufacturers Associations, Self-Regulation of Marketing Practices (Geneva: IFPMA, 1997), Code of Pharmaceutical Marketing Practices (1982-2001); .
N.J. Keuthen, P. Cyr, J.A. Ricciardi, et al,. Medication withdrawal symptoms in obsessive-compulsive disorder patients treated with paroxetine. J Clin Psychopharmacol, 1994 June, 14 No 3, 206-207
C. Medawar, The Antidepressant Web, Int J Risk & Safety in Medicine 1997 October, 10, 2, 75-126. See numerous additions, 1998-2001, at http://www.socialaudit.org.uk/5100what
S. Oehrberg, P.E. Christiansen, K. Behnke, A.L. Borup, B. Severin, J. Soegaard, H. Calberg, R. Judge, J.S. Price, P.C.Waller, S.M. Wood (Medicines Control Agency), A.V.P. Mackay (Committee on Safety of Medicines): A comparison of the post-marketing safety of four selective serotonin reuptake inhibitors including the investigation of symptoms occurring on withdrawal, Br. J. Clin. Pharmacol., 1996, 42, 757-763.
J F Rosenbaum, M Fava, S L Hoog, R C Ascroft, W B Krebs: Selective Serotonin Reuptake Inhibitor Discontinuation Syndrome: A Randomised Clinical Trial, Biol Psychiatry, 1998, 44, 77-87.
Uppsala Monitoring Centre: printout dated 27 January 2001 of ‘Most reported dependence drugs 68 to date"
World Health Organisation: Ethical Criteria for medicinal drug promotion (Geneva, WHO, 1988)
World Health Organisation: WHO Drug Information, 1998, 12, 3, 136-138.
World Health Organisation: International Classification of Diseases, 10th Edition. (Geneva, WHO, 1992)
AH Young, A Currie, Physicians’ knowledge of antidepressant withdrawal effects: a survey, J. Clin Psychiatry, 1997, 58 (suppl 7), 28-30.
Appendix One(a) a strong desire or sense of compulsion to take the substance;
(b) difficulties in controlling substance-taking behaviour in terms of its onset, termination or levels of use;
(c) a physiological withdrawal state ... when substance use has ceased or been reduced, as evidenced by the characteristic withdrawal syndrome for the substance; or use of the same (or a closely related substance) with the intention of relieving or avoided withdrawal symptoms
(d) evidence of tolerance, such that increased doses of the psychoactive substance are required in order to achieve effects originally produced by lower doses (clear examples of this are found in alcohol and opiate dependent individuals who may take daily dose sufficient to incapacitate or kill non-tolerant users);
(e) progressive neglect of alternative pleasures or interests because of psychoactive substance use, increased amount of time necessary to obtain or take the substance or to recover from its effects;
World Health Organisation: International Classification of Diseases, 10th Edition. (Geneva, WHO, 1992)
Selection of comments from users of paroxetine (Seroxat, Paxil, Aropax) posted to discussion boards (1999-2002) at http://www.socialaudit.org.uk
| Date | Responder | Quote |
| 21 Jan 1999 | Anonymous | "I was on Paxil 20mg once per day X's 4 months. Not very long. I stopped taking the medication abruptly because I was not told any different. The warning label on the medication was not significant enough to alarm me. The withdrawl symptoms I experienced were terrifying. Dizziness, chills, very vivid awful nightmares, nausea, anorexia, headache, and diarrhea." |
| 17 Oct 1999 | Anonymous | "two weeks ago I stopped taking them. I was fine for the first 5 days other than I began to feel extremely fatigued. On the sixth day, however, I began to feel sick and for the next 8 days experienced the most weird and disstressing physical symptoms I have ever had the misfortune to suffer. These included dizziness, sweating acute nausea, gait instability-like being drunk or walking on the deck of a ship. Also jolts/rushes to the head like being in a lift decending rapidly. There were lots of other insidious symptoms ie visual disturbances etc and to begin with I did not associate these symptoms with seroxate withdrwal, I suspected that there may be a link but after reading the manufactures leflet which accompanied the tablets I dismissed the idea thinking I must be suffering from something much more serious. I made an appointment with the doctor to find out what serious condition I could be suffering from that would cause these very disstressing symptoms and it is at this point I discover through the internet that I am indeed suffering from Paroxetine withdrawal reactions. Having gone through 8 day of withdrawal I have no intention of going back on seroxate to eleviate my present condition in the hope that the worst is over and I will soon be "back to normal" pysically. I would not like to predjudice any ones use of seroxate with my experience, no doubt it can and does help some people but I think the manufacturer is guilty of not stating more clearly how bad it can be actually comming off the drug-after all I was only on a low dose for a very short time!" |
| 27 Oct 1999 | Kim Andrews | "I have been taking Seroxat for 10 months…I also tried to come off it like so many of you. I can only say it scared me to death. I am now on a half dose but I am experiencing tingling, numbness, ear ache, muscular pains and memory loss. My skin is also very itchy. I feel so mad that I was not warned by the makers of this drug" |
| 31 Oct 1999 | Anonymous | "I was on Seroxat (40mg) for 1 year when I decided the time was right to start decreasing my dose…I slowly decreased the tablets, this took place over 4 months, not because anyone advised me to withdraw slowly but because I was frightened of spiralling back into depression. Once I was on 10mg (half a 20mg tablet) per day I was advised to take 1 tablet every other day. On my first day without a tablet by 16.00 I started feeling ill - dizziness, sickness, headache etc. This deteriorated until I physically could not get out of bed. I had no idea what was happening. My husband thought I should take a tablet, just in case, and within 3 hours I was starting to recover. Despite this experience I wasn't totally convinced it was the tablets to blame for those symptoms - so I tried again and again. Eventually I returned to my doctor for help. I was told in no uncertain terms it is impossible to be addicted to Seroxat and that 'it was all in my mind'. I was sent away to try again. I tried as many ways as I could to reduce the dose further but I could not decrease my dose below 10mg." |
| 18 Nov 1999 | "ppitz" | "I have been taking seroxat for about 9 months. I stopped taking it 14days ago. I feel angry my dr. never told me of the horrific withdrawl symptoms. I have had such a variety of weird symptoms it would be hard to list all of them. The worst has been this tinny electrical swooshing feeling between my ears. It's aweful. Also like going down a lift too fast. I couldn't sleep but felt too bad to do anything. Now 14days later it is 3:30am and I still have insomnia. Sometimes my feet feel incredibly cold and last night they felt really hot and itchy. My legs ache something fierce. The latest is for the last 24 hours I have had the strangest still neck. After 2 weeks I am distressed I still feel the swooshing electrical feeling in my head." |
| 23 Nov 1999 | Anoymous | "I have taken the seroxat for 10 months…2 months ago i started to come off "it". Almost immediately i had withdrawal symptons, the worst being these "electric shock"/dizziness/disturbances of vision that alot of people above seem to have experienced. I also had nausea, itchiness(several times i combed my hair for nits!!)sweatiness muzziness etc etc…is it naive of me to expect the drug companies to have researched this??" |
| 16 Dec 1999 | "Catherine" | "How long does the withdrawl take? Does anyone have an idea? I feel worse now then when I was prescribed Seroxat. I left a happy little message a couple of mths ago 'how nice to smile...the way to re-find myself' lies all lies if I knew then what I know now. I will never again touch anti-depression drugs and if anyone ever asks my advice I'll suggest they get their doctor to try some before they go prescribing these personality sapping horrible things. I want my body to be rid of these chemicals. I want me back. I want to be in control of my emotions. I don't want to be this irrational and sick to the bottom of my stomach. Please can anyone give me an estimate ??? I've been taking 2omg for 6mths now and i'm trying to push my body as far as I can to rid this drug, while still attempting to live a 'normal' life … I can't believe I'm here trying wean myself off these drugs." |
| 26 Dec 1999 | Anonymous | "This is my final withdrawal ( I was weaned off)and I definately feel that shaky vision, dizziness, nausea, way irritability and worse- slow, tortuous gray." |
| 28 Jan 2000 | Anonymous | "I have been taking Paxil for about 7 years. I just keep getting refills and nothing else. I have tried several times to wing myself, but no luck. When I decrease the paxil I immediately have horrible headaches, nausia, and dizziness." |
| 30 Mar 2000 | "Kristin" | "Went OFF the Paxil 2 months later. It's been 10 days, and it's also been a living hell. Someone here compared the feeling in the head to being dropped in an elevator... EXACTLY.... extreme mood swings, amazing rage and anger … nausea. The worst side-effect is definitely that strange floaty head-thing. Feel like I'm going crazy…Not until I began looking around at sites like these (thank goodness for them) did I feel that people out there understood how I was feeling and that Paxil was definitely the culprit." |
| 20 April 2000 | Roger Bradley | "I've been taking Seroxat for 5 years. I started out taking 20mg/day which was reduced to 10. My GP wrote to me three weeks ago asking me to go and see him regarding my continuing use of Seroxat. When I saw him I described the results of a previous attempt to stop, vertigo, mood swings etc. He stated he had never heard of any withdrawal effects related to this drug!!!…I'm now taking 2.5mls/day. Yet the symptoms of withdrawal are if anything worse than they were before if, as I did the other day, I miss a dose. Within 24hrs of missing the 2.5ml dose I was feeling suicidal, aggressive, sick, dizzy and exhausted. I don't know where to go to get advice on how long these effects are likely to last. My GP is the last person I can turn to. Does anyone know where I can get the help I need? I don't ever want to feel the way I felt a couple of days ago again." |
| 2 May 2000 | Susan Smith | "After a year and a half I am now coming off seroxat. I took my last tablet - 20mg - about a week ago. My GP (doctor) advised me that there should be no adverse symptoms if I tailed off gradually, which I did. Two days ago I experienced disorientation and dizziness, and nausea. I am also experiencing extremely vivid dreams and cannot sleep, and these symptoms continue. I was relieved to read on this site that I am not alone..." |
| 1 June 2000 | Sean Moore | "Oh my God, I cannot believe how many others are/have experienced the hellish withdrawl effects of coming off Paxil!?! I have been going through a personal hell the past 5 days as I have discontinued my Paxil addiction…I feel like I am going insane and have no one to turn to for help. No one can understand the horrendous effects of coming off Paxil unless they themselves have experienced it. Over the past 5 years of taking 10-30 Mg of Paxil, I have failed 3 times at coming off it. I am not going back this time, despite having every withdrawl symptom described by others. My life is hell right now and I am gathering every ounce of strength I can muster to get through this on my own. Work is impossible- I just sit at my desk. I can barely walk, never mind partake in my usual physical activities!! I am alone and need help, yet there is none. I HATE EVERY SINGLE PERSON INVOLVED IN DEVELOPING AND PRESCRIBING PAXIL AND I HOPE THIS HORRIBLE ADDICTIVE DRUG IS TAKEN OFF THE MARKET ASAP!!!" |
| 7 June 2000 | Anonymous | " have been taking Paxil for three years now - 20-30mg - and would like to get off it. I have already tried to taper the dose on a number of occasions and had horrible side-effects within days." |
| 14 June 2000 | "Sally" | "After three or four failed attempts to come off - and plunging into terrible depression/anxiety again - it has now taken me from June 1998 to the present to reduce from 20mg - 7.5mg. I'm having to do this last bit even slower. Recently dropped to 5mg - felt crap - returned to 7.5mg. I'm furious about the whole thing and feel my life has been messed up big time over the last 6 years by this drug. Still I try to keep optimistic and think I'm better off on 7.5 than 20mg. I'm determined to beat this drug - but like you often lose hope. I also wonder can the withdrawal be "sat out". It usually hits me big time about two months after stopping - and then becomes unbearable again. I suppose I'd rather feel ok (and very angry) on it than totally shitty off it. I'm treating it like Valium (ie mega small reductions)- but there doesn't seem to be anyone around to help advise on this (or who's willing to admit it's addictive or just take what the patient is saying as a good indication of what's going on)." |
| 17 June 2000 | Nicole | "I was on 20mg Paxil for almost two years …for the last month I have tapered off and am now at 5mg every 2-3 days. Yes I get the whooshy feeling in my head, dizziness, and a lot of other withdrawal symptoms mentioned here." |
| 20 July 2000 | David Watson | "I am, at the present time, trying to come off Seroxat. I was originally on 40mg a day in 1994 but I have reduced this to 15mg one day and 10mg the next (using Seroxat liquid). I am experiencing major sleep problems at the moment, ie, very vivid and frightening nightmares and a feeling of extreme nausea which does not seem to clear until, perhaps, the afternoon. Whenever I have visited my local GP, he is under the impression that there are no withdrawal symptoms coming off Seroxat (Paroxetine). How wrong he is! This is about the third time I have tried to wean myself off these tablets - the two prevous times that I have attempted this have failed and I have had to up the dose to the previous level." |
| 16 Oct 2000 | "Jane" | "I've now been on paroxetine for 6 years with 3 failed attempts to get off (which I think is due to the withdrawal problems)… All I know is I wish I had known a better alternative, for me, when I started taking Paroxetine … I was previously on a tricylic and had no problems with this." |
| 10 Feb 2001 | Anonymous | "I'm about 3 weeks out from my last seroxat... tapering down from 10 through 5 mg/s per day, to 5 every other day over 3 weeks. All the symptoms are there. I like the description of wooshes... like being totally decentred, and having your vision flickering in front of you to the pounding of pulses in your head … I'm still having all the other symptoms mentioned, but particularly the nausea at the moment..Yes I'd like to sue skb for all they’re worth and having had no joy or even remote concern from their phone helplines I'm feeling very cross." |
| 16 March 2001 | Martyn Guilbert | "Like most of you, I was told that this stuff does not lead to dependency. I have been on 20mg for a year … I reduced to 10mg for about a month, then quit completely 7 days ago. I am now experiencing the full range of withdrawal symptoms, diziness, light headed feeling, inability to concentrate, insomnia, sweating, mood swings, etc.etc … Reading the literature kindly supplied with our happy pills gives the user absolutely no warning that these withdrawal symptoms are likely - well not good for sales is it! It is certainly comforting to read this message board and know that my symptoms are not unusual. I hope there are lots of folks out there who have succeeded in weaning themselves off. Lets hope I am the same person when I get off the Seroxat carrousel." |
| 20 April 2001 | Sharon | "I am on my 9th day of withdrawal from seroxat. I was on (20mg) a day for 14 months after being diagnosed of post-natal depression after my second child, and have been reducing by taking (10mg) a day for the last month i feel extremely ill at the moment and i have experienced nearly every withdrawal on this site. I am getting that buzzing in my ears and electric shocks in my head as i call them as i type this out, i also feel very sick and extremely dizzy. Please tell me how many more days will i suffer … i don't even remember the depression being this bad." |
| 8 May 2001 | "Trudi" | "I am so glad I’m not the only one! After 4/5 years on seroxat, i decided enough was enough …This was fine for the first 2 days, then.... BANG! Every part of my body felt tingly, numb, like all my nerves were full of electric. Parts of my face/mouth keep going numb, I have chronic headaches, ringing in my ears, throat restriction, and the panics are returning with a vengeance!" |
| 21 June 2001 | "Tanya" | "I'm getting to the end of my tether with Seroxat and trying to come off it - been trying for nearly 6 years - including very gradual reduction. Prior to the Seroxat nightmare - I was previously on (seven years before) - prothiadin and had no problems coming off. If only I hadn't been seduced by my GP's promise of no side effects / no risk of addiction to Seroxat!! Can anyone help? Where is the professional help with this and acknowledgement that we all need detailed research and informed guidance to get off this shit!" |
| 25 July 2001 | "Anna" | "AT PRESENT I AM SUFFERING FROM THE WITHDRAWL SYMPTOMS OF SEROXAT (AS WELL AS MY FAMILY). I AM SO RELEIVED TO HAVE FOUND THIS WEBSITE SO THAT I CAN RELATE TO WHAT IS ACTUALLY HAPPENING TO ME. AS ONE OF MY SYMPTOMS IS INSOMMNIA I HAVE BEEN DOING A LOT OF RESEARCH LATE AT NIGHT. AT PRESENT I AM VERY ANGRY AT THE PHARMACUTECIAL COMPANY RESPONSIBLE FOR THIS DRUG FOR NOT PUBLISHING THE WITHDRAWL EFFECTS IN THEIR NOTES AND GUIDANCE FOR PATIENTS. I AM GOING TO GO FURTHER WITH ALL THE INFORMATION THAT I HAVE TO A LEGAL REPRESANTITVE AND LET THIS COMPANY KNOW THAT WHILE THEIR PROFITS AND SALARIES ARE SOARING MYSELF AND MY FAMILY ARE CRUMBLING ALL BECAUSE THEY FORGOT TO LET THE ORDINARY PERSON KNOW THAT THE WITHDRAWL SYMPTOMS ARE FAMILY-BREAKERS AND LEAVE PEOPLE WITH A MONSTER IN THEIR MIDST" |
| 28 July 2001 | Anonymous | "I am writing mid withdrawal from Seroxat after being on them for a year for depression and anxiety. Although I cut down gradually over a month from 20mg a day (on Doctors advice) I am still having quite awful symptoms: "electric shocks" in my head, "whooshing", dizziness, mood swings, uncontrollable crying, upset stomach, tremors, swelling of my face and incredibly vivid nightmares! It has been a week now since my last tablet and the withdrawal seemed to start 2-3 days after that. I just hope that these symptoms go soon. This site, and others like it, has been invaluable as the doctors and even psychiatrists that I know had never heard of Seroxat withdrawal and thought I had a virus! I was so scared of the weird feelings in my head that I decided to search the web and here I am feeling 100% better just from knowing that I am not going mad!" |
| 9 Aug 2001 | Anonymous | "I have been on Seroxat for 18 months and have tried on three failed occassions to come off. The first time I reduced my dosage very carefully over a two month period but the side effects/withdrawal just kept getting worse and worse. Elec shock sensations in my head, joints aching, very very depressed feeling of going to have a convulsion or stroke or something horrible. A very clear feeiling of death. I ended up in A&E ST Mary's London and was told by the Doctor to go back immediatley onto seroxat to help my problems...I did and within hours I was fine again. The second time I thought I'd give it another go and failed again due to the impossible strain of the side effects. The third time I knew what to expect and decided to go hell for leather and this time it was not going to beat me. The first three weeks without a single tablet was very hard similar to the other two occassions but the weeks following other symtons started to appear that hadn't before. Like my hand going numb in the night. My sleep felt so weird like I was going into unconciousness I was terrified of going to sleep in case I didn't wake up. I wasn't sure if this was the discontinuation of the tablets or was there something else wrong with me...it was very worrying. I went to see a private GP … He was very understanding but again I have been told to go back on Seroxat. In my hour of desperation on Monday gone I took a tablet and hey presto after seven weeks of going through hell my symptons all disapeared…How the hell can one get off these cursing tablets???? I have tried and tried in a number of different ways." |
| 28 Aug 2001 | Michael Thomas | "I have become unwittingly a Seroxat 'junkie', having been on it for over seven years. My dose was increased from 20 to 30mg daily in 1996. I was never told about dependency, yet I find now that it is the most addictive antidepressant. I get nasty dizzy spells and other symptoms when going over a day without it. I feel that I am now totally dependent on it for the rest of my life." |
| 8 Sept 2001 | Adrian Keefe | "I took Seroxat for 6 months
(20mg/day)…I tapered off of seroxat fairly gently (2 weeks of alternate 10mg/20mg, 2
weeks of 10mg, 1 week of alternate 10mg/0mg). About a week later I started getting the
following symptoms: -Vertigo -Strange pulsing sensations, starting in the head and going round the body -mood swings, unexplained feelings of wanting to sit and cry for no reason (but NOT like my old "black days" feeling) -sharp headaches/migraine symptoms (light/sound sensitivity) - lack of concentration/memory loss - lack of coordination/clumsiness - sudden irritability - stomache cramps - noises in my ears - continuous belching This has been going on for four weeks. I can hardly work, and cannot drive since my sense of distance is affected. I have no idea how long it may go on for." |
| 9 Sept 2001 | "Annie L" | "I have unwittingly become addicted to Seroxat - it no longer treats my depression but despite 2 attempts I have been unable to come off it as the withdrawals are so bad (panic attacks, complete and utter distress, palpitations, sweating etc). I am very angry and frightened." |
| 17 Oct 2001 | "TB" | "Following three unsuccessful attempts to come off Seroxat, I have now been told by both my doctor and my psychotherapist that it would be best for me to stay on it as the withdrawal symptoms are too extreme. Despite the fact that I prescribed it for anxiety and not depression and have now dealt with the issues causing the anxiety attacks and no-one believes they will come back or that I need any medication to stop anxiety." |
| 3 Nov 2001 | "Kathy" | "I have also been on Paxel and have weened myself off. I have not been on it for 3 weeks now and still get the crazy sensations. Shocks, dizziness, grumpiness, etc. How long does it take for this to go away. My physician says this is not associated with Paxel. This is the only thing I have taken. I am now scheduled for a CT Scan. HELP!!! What to do? Can't stand this anymore" |
| 28 Dec 2001 | "Attilla- Bondi" | "I've just started coming off Aropax about 2 weeks ago. Dropping from 1 tablet; to half; to half every 3 day & now to none. (about 5 days ago)… No one ever told me the hell of the accompanying withdrawal symptoms. I was going to admit myself to hospital again today as I couldn't take the side-effects anymore. Then I went net surfing this morning to get more info in discontinuation & came across this site. Oh..., how exact some of you have described these dreadful symptoms … God, give those doctors and medical practitioners a good kick up the arse for their lack of assistance and support. If only they went through what we have had to endure. Thank you all for giving me hope in life once again." |
| 31 Dec 2001 | "Tad" | "I have been trying to get off Paxil for several months now. Even did 5 mg for 30 days before going to zero now for 3 weeks. I have extreme headaches, extreme nausea, tingling in my extremeities (when I don't have head aches only)… Taking 5 mg again helps but I desperately need to get past this and not getting any better." |
| 1 Jan 2002 | Susan Hucklesby | "I've been on seroxat for about 10 years, and have tried to come off of them on many occassions. Only to find myself back to my original dosage of 30mg because of the horrible withdrawals. Which i was assured when talked into taking anti-depressants in the first place were one of the mildest and non addictive so called "wonder-drug" in modern psychiatry." |
| 3 Jan 2002 | "Amber" | "I have been trying to get off of Paxil for about two years now. (I have been on it for 4.) This is by far the hardest thing I have ever been through. I thank God for you all who willingly share your stories, because I think it has kept many people from taking their own lives. At least your stories show us that we are not alone, and we will not go quietly. I have been having hallucinations, vertigo, "zaps", fear (debilitating), tingling in my tongue and limbs, sensitivity to noise, paranoia, and depression just to name a few. It is by far a crime what this company has put us through."
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| 26 Jan 2002 | Felicity Main | "I'm also a 2 year user of Seroxat and have been trying to come off it the last couple of weeks. Week one went from 30 to 20mg with headaches being the only problem, but week two when I actually missed it for a couple of days and then was taking 10mg a day was when the 'flashing', dizziness, flu symptoms etc started. And I thought the side effects on the drug were bad enough!! I'm…desperate to come off this so I can start a family. I'm positive that the side effects on the drug were causing more distress and depression and upset in my life than the original anxiety/depression ever did!!!! I think the drug company and GP's do have a lot to answer for and would like to see GP's looking at alternative ways of treating depression/anxiety than by prescribing pills straight away." |
| 7 Feb 2002 | "Bev" | "After taking paroxetine for 9 months i went to see my gp who told me how to cut my dosage (20mg a day) - i followed his instructions to the letter. After a month i am completely off the drug & have been experiencing horrible dizzy spells for the past week & a half. The headaches are pretty nasty too. felt sure i had a brain tumour so back i went to my 'helpful' gp who said (a) could be pregnant (b) could be a virus (c) could be the paroxetine withdrawal. After reading some of the comments on this site i am convinced its withdrawal. i am determined to stick with this because one of the solutions the doc gave me was to go back on the tabs & try a slower withdrawal. does this sound crazy or what? if i do that i think i'll NEVER get off these damn things. Oh yeah, this is after i was told that they are DEFINITELY not addictive." |
| 18 March 2002 | Lorraine Love | "I have been taking the terrible drug for 4 years now and have tried many times to give up but because of the horrible withdrawel symptoms I experienced, I had to go straight back to them. Thank god for finding this site. I didn't understand any of the symptoms I was experiencing. When I went to my doctor she told me that it couldn't be the seroxat because they have no side-effect...after reading this I realise that is not the case at all." |
| 30 March 2002 | "Una OM" | "I've just come off Paroxetine 12 days ago. I have been on 40mg for over a year. Having stopped taking them gradually I've had all the totally weird symptoms described on this bulletin board- whooshing in my head, tingling. electric shocks, stomach problems, bizarely muddled thought processes. I can still just about function, although my job requires me to be pretty analytical and 'together'- two things I'm not feeling at the moment. Others out there might find this interesting- I've never suffered from depression, I was put on paroxetine for ME. But boy did I feel totally emotionally shatterd when I came off the medication- I've never felt so unable to cope in my life." |
| 26 April 2002 | "Vanessa – UK" | "I have been taking 20mg seroxat for 3 years - I have been trying to come off it for two years!!! My last attempt started 8 months ago and after a lot of pain and grief I am down to 2mg. I thought I was safe to stop it - how wrong I was! I started to feel confused, irrational and hopeless-as well as crying uncontrollably. I rang my doctor in tears and begged him to help me- he advised to take 2mg straightaway - I felt better almost immediately. I then went to see him - he wouldn't believe that it was the withdrawal- he tested me for underactive thyroid - tests normal! He has never heard of this problem and tells me it could be my depression coming back - I couldn't believe it - doctors need to be told! I am so angry - I sometimes feel I'll never be off it - thank God for this website!" |
| 29 April 2002 | "Libby" | "it seems to me there is a jarring difference between the academic research findings on withdrawal effects and people's lived experiences. If researchers had experienced some of the severe SSRI withdrawal symptoms themselves, they would not be discussing whether they are 'psychological', symptoms of depression being unmasked, or the result of having a 'dependent personality'. About five years ago, I suddenly stopped taking paroxetine, which I'd been on for a few months. I'd had no advice that I should taper them off and at that time I had not heard of withdrawal effects from SSRIs so when I started to get symptoms I did not relate them to stopping the drug. Within a few days I started to get an occassional sensation that the floor was rising up in a wave beneath me, coincinding with parasthesia over the top of my tongue...Over two or three days symptoms worsened until not only was the floor going up and down and my tongue constantly tingling but things around me also appeared in a state of flux moving in and out and I soon found myself cowering in the corner of the staircase at work, two unsteady to move. A particularly strange and disturbing symptom was that every time I moved my eyeballs there was a 'whooshing' noise *inside my brain*… Quite a bit later I read about withdrawal effects and recognised these symptoms for what they were." |
| 8 May 2002 | Joanne Dean | "I am now 2 weeks into withdrawal and since my last posting can honestly say that I feel worse. My head spins so fast sometimes that I am physically sick. Every morning I wake up thinking that today might be the day when I feel slightly better but so far that is not to be. I still can't believe that a drug that was prescribed to help depression can make you feel like this. I only wish that my doctor had been more honest with me. If it hadn't been for this web site then I would really think I was going mad." |
| 9 May 2002 | "Vivian" | "I am two weeks into Seroxat withdrawal, after having been on it for a year and a half. I tried six months ago to reduce the dose (20mg daily to every other day) and had to go back to the original dose after severe depression and horrible physical symptoms. This time I've gone cold turkey and am on a deeper level much more emotionally positive. On the surface though I have become a ratty, short tempered individual, although I think that this is due to the constant horrendous physical symptoms of withdrawal (I found giving up smoking after 10 years less physically traumatic). I have near constant dizziness, nausea, insomnia, jumpiness and extreme irritability." |
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