abandons 'no addiction' claim
6, 2003 - Source:
drug company which makes Seroxat, the antidepressant which thousands
of people say they cannot give up because of severe withdrawal effects,
is to drop the claim on its patient leaflet saying the drug is not
admission of a change of policy from GlaxoSmithKline, Britain's
biggest pharmaceutical company, comes in a BBC Panorama programme
to be shown on May 11.
from the Edge examines the big response from Seroxat users to its
first investigation, in October, of its withdrawal problems.
is a commonly prescribed antidepressant of the SSRI (selective serotonin
re-uptake inhibitor) class, to which Prozac also belongs.
people say it has changed their lives by lifting them out of depression,
but some experience distressing side-effects when they try to reduce
the dose and stop taking it. These effects are said to include sensations
comparable to electric shock.
July the Guardian revealed that Seroxat topped the league table
for complaints of side-effects made by doctors to the government's
committee on the safety of medicines under the yellow card scheme.
A total of 1,281 complaints were filed - more than the combined
amount for the rest of the top 20 most cited drugs.
watchdog group Social Audit complained at the time about the wording
on the Seroxat patient information leaflet. It states that "these
tablets are not addictive", and that withdrawal problems "are
not common and not a sign of addiction".
Benbow, head of European clinical psychiatry at GSK, says in the
film that the wording was poorly understood by patients. Yesterday
he told the Guardian that he accepted that the drug, like other
medicines, did cause physiological changes. "It is absolutely
right, some people have symptoms and for some those are very troubling."
GSK is unlikely to head off the mounting criticism because it intends
to keep the advice issued in a separate information sheet to doctors
which says the drug does not cause dependence.
Healy, director of the North Wales department of psychological medicine,
has long argued that the company should change its advice to doctors.
there is withdrawal, then there is physical dependence. There will
be some people who will never be able to halt this drug, there will
be some for whom halting will not be awfully difficult and some
for whom it is a real issue." The SSRIs were not like opiates
such as heroin which causes drug depmcency as opposed to physical
dependency, he said. They were more comparable to the benzodiazepines
such as Valium, which is now prescribed only with great caution
because of withdrawal problems.
Medawar, of Social Audit, was not impressed by GSK's move. "My
feeling is that the changes GSK proposes could and should have been
made at least five years ago and will not tell patients anything
they don't know. They are glossing over the reality. This is far
too little, too late."
Venn, of the Seroxat users group which has 4,000 members, said:
"We are pleased to have this news but it doesn't address the
information provided to doctors. It doesn't go anywhere near helping
patients who are on this drug and can't get off it."
patients complain of doctors lacking sympathy when told about the
Dr Benbow said GSK's "feedback" showed doctors did understand
what was meant and he could see no reason to spell out the difference
between "physical dependency" and "drug dependency".
think we would start to get into difficulties of definition."
He said the wording of the doctors' leaflet should only be changed
"if we think there is a clear lack of understanding [by] the
doctors," he added.
16, 2003: Coroner calls for inquiry into Seroxat - reports
20, 2002: BMJ review on Panorama's "The Secrets of Seroxat"
- how plausible was this documentary on the addictive component
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