Posted by BobS. on February 21, 2002, at 19:14:42
In reply to Re: Psychiatry doesn't know how treat anxiety!, posted by OldSchool on February 21, 2002, at 18:12:38
260 BMJ VOLUME 324 2 FEBRUARY 2002 bmj.com
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 ‘nonhabit
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 prolonged—and
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.”
Withdrawal from paroxetine can
be severe, warns FDA
Alison Tonks Bristol
328, 25, 186
poster:BobS.
thread:94977
URL: http://www.dr-bob.org/babble/20020215/msgs/95039.html