Fwd: [SSRI-Research] Formal Complaint to GSK - Charles Medawar

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[sSRI-Research] Formal Complaint to GSK - Charles Medawar

 

Social Audit Ltd

P.O. Box 111 London NW1 8XG

Telephone/Fax: 0207 586 7771

mail and http://www.socialaudit.org.uk

 

http://www.socialaudit.org.uk/4632-XSA.htm#Dear

 

 

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

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; 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:

1.. The outcome of our previous complaint, and the company's acceptance of

that decision and " assurance that they will take all possible steps to avoid

similar breaches of the IFPMA Code occurring in the future " . (The remarks

attributed to Mr. Chandler do not suggest that steps have been taken, but we

keep an open mind on this. If the company has taken any steps, we invite them to

explain what has been done.)

2.. The evidence provided indicates an established pattern of unacceptable

behaviour

3.. That misleading statements were made to a lay rather than professional

audience

4.. Mr. Chandler's seniority in the company.

5.. The damaging consequences of such statements for patients and prescribers

alike.

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 definite diagnosis of dependence should usually be made only if three or more

of the following have been experienced or exhibited at some time during the

previous year:

(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;

© 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;

6.. persisting with substance use despite clear evidence of overtly harmful

consequences, such as harm to the liver through excessive drinking, depressive

mood states consequent to periods of heavy substance use, or drug related

impairment of cognitive functions; efforts should be made to determine that the

user was actually, or could be expected to be, aware of the nature and extent of

the harm ... "

World Health Organisation: International Classification of Diseases, 10th

Edition. (Geneva, WHO, 1992)

Appendix Two

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. "

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 © 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. "