Paxil Withdrawal - A Review of Literature and Foreign Labels

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Paxil Withdrawal

A Review of Literature and Foreign Labels

http://paxilprotest.com/page17.html

 

Going through a severe Paxil withdrawal is like being dragged into the

event horizon of a " black hole. " Once withdrawal takes hold no amount

of resistance or determination can stop what's next: total personal

annihilation. It's like being murdered, shredded to pieces from the

inside out, but you're still alive....

 

- Paxil withdrawal survivor

 

 

 

Physicians in the U.S. are bombarded with marketing messages designed

to minimize concerns surrounding withdrawal. For instance, GSK uses

the term " discontinuation syndrome " rather than " withdrawal " because

it infers " addictive " qualities. In fact, the term " discontinuation "

is not even a legitimate medical term - it is not listed in any

recognized medical dictionary. GSK's contrived distinction between

" discontinuation " and " withdrawal " is wholly inconsistent with the

language found in foreign labels for Paxil, wherein GSK acknowledges

that Paxil can cause withdrawal symptoms:

 

Italy: " Withdrawal symptoms may occur if treatment is discontinued

abruptly. Such symptoms ... include: insomnia, dizziness, sweating,

palpitations, nausea, anxiety, irritability, parasthesia and headache; "

 

UK: " [W]ithdrawal symptoms have been reported on stopping treatment.

.... Dizziness, sensory disturbance (e.g. parasthesia), anxiety, sleep

disturbances (including intense dreams), agitation, tremor, nausea,

sweating and confusion have been reported following abrupt withdrawal

of 'Seroxat' [Paxil]; "

 

Ireland: " Withdrawal reactions have been reported following

discontinuation of 'Seroxat' [Paxil], these include dizziness, sensory

disturbance (e.g. paraesthesia), anxiety, sleep disturbances

(including intense dreams), agitation, tremor, nausea, sweating and

confusion; "

 

Netherlands: " [A]brupt discontinuation of Seroxat therapy must be

avoided as this may result in withdrawal symptoms such as sleep

disturbances, sensory disturbances, dizziness, agitation or anxiety,

sweating and nausea; "

 

Spain: " Withdrawal symptoms[.] Discontinuation of paroxetine

administration (especially if it is abrupt) may lead to withdrawal

symptoms such as dizziness, sensory disturbances (including

paraesthesia and sensation of cramps), headache, sleep disturbances,

agitation or anxiety, nausea and sweating; " and

 

France: " Abrupt withdrawal of the treatment may cause, within one

week, symptoms such as dizziness, sensory disorders, sleep

disturbances, agitation and anxiety, asthenia, digestive disorders and

sweating. These signs may persist for 1-2 weeks. "

 

GSK continues to assert that " discontinuation symptoms " happen with

all antidepressants and are " generally mild " and " self-limiting. " And

at one time GSK stated in its promotional material: " Is Paxil

addictive? No. Paxil is not a controlled substance. Paxil belongs to a

class of medications called SSRIs, which have not been shown to be

associated with addiction. " However, according to the World Health

Organization publication, " WHO Drug Information, " Volume 15, No. 1,

2002, concerning the December 14, 2001 label change: " The Food and

Drug Administration has published a product warning for paroxetine

regarding severe withdrawal symptoms of the kind that could lead to

dependence. "

 

GSK also continues to make statements such as " in most instances "

withdrawal effects are simply " relapse. " (Glamour Magazine, April 2003.)

 

This is entirely inconsistent with the Paxil label in Switzerland,

which states:

" Discontinuation of Seroxat may lead to discontinuation symptoms.

Typical symptoms include nausea, anxiety, dizziness, sensory

disturbances (including paraesthesia), headache, sweating, agitation,

fatigue and tremor. These symptoms usually start abruptly within a few

days of discontinuation and can be distinguished from relapse

symptoms, which occur later and build up gradually. To prevent such

discontinuation symptoms paroxetine should be discontinued slowly and

with a gradual reduction (maximum 10mg/week). "

 

The truth is, from its inception onto the U.S. market in December 1992

to the present, medical researchers throughout the world have

documented Paxil's propensity to induce dependence/ withdrawal

symptoms when patients attempt to reduce or discontinue taking Paxil.

These observations have been published in an abundance of peer

reviewed medical journal articles. In fact, after a very short time on

the market (in 1993), the Committee on Safety of Medicines ( " CSM " ),

the U.K.'s counterpart to the FDA, reported 78 cases of withdrawal

after discontinuation of Paxil and noted that " such reactions have

been reported more often with [Paxil] than with other SSRI's. "

Although GSK has been aware for the past decade that Paxil can cause

withdrawal, this vital information was not included in the drug's

label. Although GSK was required by the FDA to strengthen its warning

about Paxil withdrawal in December 2001, many in the public allege

that it remains inadequate.

 

The medical literature also points out that Paxil has the highest

incidence of withdrawal reactions, " significantly more frequent than

with other SSRIs. " According to one study involving four SSRIs (Paxil,

Prozac, Zoloft, and Celexa), wherein Paxil was by far the worst in

causing withdrawal effects, the authors stated that the withdrawal

effects seen with Paxil were " not evident in patients receiving

(Prozac), (Zoloft), and (Celexa), suggesting they are not an SSRI

class phenomenon. "

 

If discontinuation reactions occur in patients stopping (Paxil), the

majority will experience symptoms that are mild to moderate in

intensity, and are usually limited to two weeks.

 

-Mary Anne Rhyne

GSK spokesperson

2005

A review of the literature shows that, on average, over one-third of

people taking Paxil for any extended period of time experience

withdrawal symptoms, and of those, 21% experience severe withdrawal

symptoms.

 

 

" Discontinuation of Treatment "

The side effects are things like dizziness, nausea, headache, um, and

are clearly labeled in the information made available to doctors and

patients. "

 

- Dr. Alastair Benbow

GSK's European Medical Director

from GSK's web site

2004

In the clinical trials of Paxil, a significant percentage of patients

(up to 50% according to some studies) experienced withdrawal, despite

the fact that a tapering regimen was utilized in those trials.

Notwithstanding these alarming figures, according to a survey

conducted in 1997 and published in the Journal of Clinical Psychiatry,

the vast majority of physicians are not aware of this problem.

According to the authors, " education about discontinuation reactions .

is needed for both psychiatrists and family practice physicians. "

These concerns were echoed in an article published in December 2000,

wherein the author stated that there is widespread " misdiagnosis of

antidepressant discontinuation symptoms " and " increased professional

awareness of discontinuation symptoms is necessary to prevent

misdiagnosis and inappropriate treatment. " Just last year, the Harvard

Mental Health Letter disclosed that as many as 75% of non-psychiatric

physicians were unaware that Paxil can cause withdrawal reactions or

how to properly diagnose the associated symptoms.

 

Despite the abundance of data pointing to a problem, GSK has never

prospectively studied the issue of Paxil withdrawal. This is

particularly disconcerting given Paxil's remarkably short half life.

According to one of the few non-confidential documents obtained by

Plaintiffs in this litigation, titled " Draft Guidelines For Abuse

Liability Assessment, " compiled by the Subcommittee on Guidelines for

Abuse Liability Assessment, Drug Abuse Advisory Committee, Food and

Drug Administration, U.S. Public Health Service states: " In general,

rapid onset, short duration drugs appear to have greater abuse

liability than do pharmacologically similar drugs with slow onset and

long duration of actions. "

 

The Slippery Slope of Semantics: " Discontinuance " vs. " Withdrawal "

 

A perfect storm is a situation where, by the confluence of specific

events, what might have been a minor issue ends up being magnified to

proportions that are out of control. In such a situation, it is clear

that if one element was removed from the mix, the whole matter would

have collapsed, but because just the right things were in the mix, the

situation balloons.

 

 

- definition of " a perfect storm "

 

The following is an excerpt taken from Medicines Out Of Control? by

Charles Medawar and Anita Hardon. This book is a must read for anyone

interested in taking a " glass-bottomed boat tour through the Paxilian

swamp; " it provides a spectacular " 3-D view " of the " SSRI/SNRI

denizens of the deep " darting about in murky depths below.

 

The word " discontinuation, " as a euphemism for withdrawal, had entered

the medical literature pretty much from the time of Eli Lilly's

Christmas-in-Arizona " consensus panel " meeting, in late 1996. In the

previous three years, Lilly had seen Paxil eroding Prozac's market

share, and Lilly had decided to fight back. The point of the campaign

was to draw attention to the withdrawal symptoms seen with Paxil.

 

Lilly needed to be sure the problem would not be perceived as

" dependence " as that would have implicated Prozac as a member of the

same class of drugs. Lilly, as it were, needed to throw Paxil

overboard but without rocking the boat. So they threw out a lifeline:

by promoting the word " discontinuation, " Lilly kept the boat afloat.

SmithKline Beecham (now GlaxoSmithKline) and the other SSRI Pharmas

grabbed at the word and developed the concept. A detailed internal SKB

briefing (revealed in 2003) advised employees that, " Terminology such

as 'withdrawal symptoms' should be avoided as it implies dependence. "

The briefing emphasized that " discontinuation events are not a major

clinical issue " and staff were advised: " Highlight the benign nature

of the discontinuation symptoms, rather than quibble about their

incidence. "

 

Publicly, SKB (now GSK) had always denied that paroxetine

(Paxil/Seroxat/Aropax) withdrawal was a problem but, behind the

scenes, the company was telling its people that Prozac caused such

problems too: " With fluoxetine, however, such symptoms may occur

several weeks later and last several months. " SKB (now GSK) also

argued that the problem wasn't the drug, but the way it was used: " The

severity of symptoms does not appear to be related to either dose or

treatment duration, but to abrupt discontinuation. " The company

concluded that the issue, " has almost entirely been driven by

marketeering and is often based on misrepresented or carefully

selected data. "

 

Over the years, and at the insistence of the Pharmas, this notion of

" discontinuation " gained ground. It readily survived the merger, in

2002, that produced GlaxoSmithKline. GSK briefed its press and media

staff to tell enquirers " Discontinuation symptoms are completely

different to addiction or dependence... " (GlaxoSmithKline: " Reactive

Key Messages and Issues Document " December 19, 2001).

 

In the same breath, GSK media people were told to say that the UK and

European regulators had investigated thoroughly, and had " concluded

that SSRIs do not cause dependency/addiction. " ... " Seroxat is clearly

shown as being neither addictive nor causing dependence. " In fact, the

European regulators had concluded that, " the lack of evidence for

dependence does not prove the absence of a problem and any evidence,

which will emerge or will be produced, should continue to be

evaluated " (EMEA, April 2000).

 

To their credit, the European regulators had abandoned the NERO

defense - no evidence of risk equal evidence of no risk - but then

they seemed to go off the rails. They produced a policy paper that

mused about the need to conduct batteries of studies on animals in

order to confirm or deny the ample human experience of withdrawal and

dependence problems (EMEA, December 2000). Nearly ten years downstream

of paroxetine, the regulators had begun to think about requesting (but

not requiring) both pre-clinical (animal) and clinical studies to

establish what thousands of users already knew. This proposal to

sacrifice some animals might best be understood as some gesture of

faith or atonement, offerings to the Gods of Hope and Delay. There was

simply no point in focusing on animal studies, when physical

dependence and withdrawal problems were already clear from the

experience of newborn infants, after exposure to SSRIs during

pregnancy. Neonatal withdrawal problems had everything to do with the

properties of the drug and nothing to do with relapse into depression.

What better model of the risk of dependence could there be?

 

If you, or someone you know, suffered withdrawals as a consequence of

taking Paxil, please report it immediately to the United States Food

and Drug Administration. This is one way consumer leverage can be

applied to GlaxoSmithKline; eventually this official documentation

will compel the company to fully disclose the " adverse side effects "

of Paxil. You can report your side effects at: MedWatch.