Fw: FDA Warns of withdrawal problems from Paxil

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----- Original Message -----

From: " Ilena Rose " <ilena@...>

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Sent: Friday, February 01, 2002 11:25 PM

Subject: FDA Warns of withdrawal problems from Paxil

From: sey

" sey " <fuchsmorrissey@...>

FDA Warns of withdrawal problems from Paxil

PLEASE POST

Paroxetine/Paxil is under-researched as stated below?????

" It is still a matter of trial and error " as stated below in this

article????

So what is new in medicine? As things have not changed and will not change

anytime soon! Why spend money on research when those in medicine who put

these NOT FULLY INVESTIGATED medicines out have the innocent general

public to use the medication unknowingly. Well again, so much for the

PRACTICE part in medicine.

Felt this article was of interest to those using Paxil/Paroxetine. At

least those using this *not fully investigated product* will begin to know

some truth that this too was under-researched and they are the one's

cutting the path in medicine when using Paxil/Paroxetine concerning

withdrawal. Good luck!

Take care, CFM

http://bmj.com/cgi/content/full/324/7332/260?maxtoshow= & HITS=10 & hits=10 & RESU

LTFO

RMAT= & fulltext=paroxetine & searchid=1012630322301_2134 & stored_search= & FIRSTIN

DEX=

0 & volume=324 & issue=7332

Medicine and the law (incl forensic medicine)

Adverse drug reactions BMJ 2002;324:260 (Ý2ÝFebruaryÝ)

Withdrawal from paroxetine can be severe, warns FDA

AlisonÝTonks, Bristol

GlaxoKline, 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 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.

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

paroxetine over 10Ýyears 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

1000Ýpatients .Ý.Ý.ÝEven 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 18ÝJanuary

the International Federation of Pharmaceutical Manufacturers Associations

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

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

promotional and were wrong.

Dr 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. "