Fwd: [SSRI-Research] Withdrawal from paroxetine can be severe, warns FDA

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[sSRI-Research] Withdrawal from paroxetine can be severe, warns FDA

 

BMJ 2002;324:260 ( 2 February )

 

News

 

Withdrawal from paroxetine can be severe, warns FDA

http://bmj.bmjjournals.com/cgi/content/full/324/7332/260

Alison Tonks, Bristol

 

GlaxoSmithKline, a leading drugs manufacturer, was last week forced to admit

that paroxetine, a widely prescribed antidepressant and the company's best

selling drug, can cause severe withdrawal symptoms when stopped.

 

The Food and Drug Administration in the United States published a new

product warning about the drug, and in the same week the International

Federation of Pharmaceutical Manufacturers Associations declared the company

guilty of misleading the public about paroxetine on US television a year

ago.

 

" This drug has been promoted for years as safe and easy to discontinue, "

said Charles Medawar, head of Social Audit, a consumer research group

specialising in medicines policy. " The fact that it can cause intolerable

withdrawal symptoms of the kind that could lead to dependence is enormously

important to patients, doctors, investors, and the company.

 

" GlaxoSmithKline has evaded the issue since it was granted a licence for

paroxetine over 10 years ago, and the drug has become a blockbuster for

them, generating about a tenth of their entire revenue. The company has been

promoting paroxetine directly to consumers as `non-habit forming' for far

too long. "

 

Mr Medawar lodged a complaint a year ago after a spokesman from

GlaxoWellcome, then a UK company, described withdrawal symptoms with

paroxetine as " very rare " during an appearance on an American television

network. The spokesman added " [withdrawal] occurs in only two out of every

1000 patients . . . Even then the symptoms are mild and short lived. "

 

In fact, withdrawal symptoms such as bad dreams, paraesthesia, and dizziness

occur in up to 7% of patients, according to the new product information. The

warning also mentions anecdotal reports of agitation, sweating, and nausea

and tells doctors to consider restarting treatment if symptoms become

intolerable.

 

The complaint was originally dismissed but went to appeal. On 18 January the

International Federation of Pharmaceutical Manufacturers Associations

announced that GlaxoSmithKline had breached two of the industry's codes of

practice. The federation ruled that the spokesman's comments were

promotional and were wrong.

 

Dr Peter Haddad, consultant psychiatrist for Salford's Mental Health Service

NHS Trust, welcomed the FDA's safety warning. He said: " Withdrawal side

effects from antidepressants are far commoner than many people realise, and

there's evidence that paroxetine has one of the highest rates. In most cases

the symptoms are mild, but in a minority they are severe and prolongedand

treatable only by restarting the drug. "

 

" There is also the danger of misdiagnosis and inappropriate investigation.

Severe dizziness can easily look like labyrinthitis. Patients should be

warned not to stop taking their antidepressants suddenly, and doctors should

taper the dose at the end of treatment, keeping a close watch for withdrawal

symptoms, " Dr Haddad added.

 

He also called for discontinuation problems to be thoroughly assessed before

new antidepressant drugs are licensed. " This is a seriously under-researched

area. There's no good evidence to help doctors get the dosing right as

patients come off treatment. It's still a matter of trial and error. "

 

 

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© BMJ 2002

 

Rapid Responses:

 

Read all Rapid Responses

 

Paroxetine

Garrett R FitzGerald

bmj.com, 1 Feb 2002 [Full text]

 

Antidepressants Interact with Aspartame

Betty L. Martini, et al.

bmj.com, 2 Feb 2002 [Full text]

 

experiences of paroxetine withdrawal

ian k. campbell, et al.

bmj.com, 3 Feb 2002 [Full text]

 

Not Just Anecdotal Evidence

Dawn Rider

bmj.com, 8 Feb 2002 [Full text]

 

Re: experiences of paroxetine withdrawal

Alfonso Carvajal

bmj.com, 9 Feb 2002 [Full text]

 

Withdrawal symptoms are very frequent and difficult to treat

Luis Pacheco, et al.

bmj.com, 13 Feb 2002 [Full text]

 

Another Paxil Nightmare

Julia A Mandeville

bmj.com, 5 Mar 2002 [Full text]

 

seroxat withdrawal

anne b conaghan, et al.

bmj.com, 19 Apr 2002 [Full text]

 

Symptoms on withdrawing from long term paroxetine

Elisabeth Kiss

bmj.com, 1 May 2002 [Full text]

 

Seroxat User Group

Derek D Scott

bmj.com, 27 Oct 2002 [Full text]

 

More over paroxetine discontinuation syndrome

Luis Pacheco, et al.

bmj.com, 17 Mar 2003 [Full text]

 

Re: Withdrawal symptoms are very frequent and difficult to treat

A Green

bmj.com, 21 May 2003 [Full text]

 

Re: Another Paxil Nightmare

Christine Pawlowski, et al.

bmj.com, 12 Jun 2003 [Full text]

 

Playing the percentages

Dan John Parnell

bmj.com, 23 Sep 2003 [Full text]

 

7% Adverse Reactions.

Jose D. Saez

bmj.com, 23 Sep 2003 [Full text]

 

Paroxetine Withdrawal The Neverending Nightmare

Deborah A Garrand

bmj.com, 12 Nov 2003 [Full text]