ONE of Britain’s most
widely prescribed antidepressants has been
linked to a seven-fold increase in suicide
attempts.
An analysis of trials for Seroxat involving
more than 1,500 patients found seven suicide
attempts among those taking the drug and only
one among those taking a placebo. Suicidal
thoughts were also commoner among those taking
Seroxat (paroxetine), by a factor of three to
one.
Almost 2.4 million prescriptions for the drug
were issued in England last year.
The data was available even before Seroxat
was first licensed in 1990, the Norwegian
researchers found. The findings are likely to be
seized on by lawyers attempting to win damages
against the drug’s manufacturer,
GlaxoSmithKline, in the US and in Britain. The
mental health charity Mind said the results were
“extremely worrying” and confirmed what it had
been arguing for years.
“By ignoring what mental health service users
themselves have said about the medication and
its effects, the drugs regulators may well have
caused lives to be lost,” said Sophie Corlett,
policy director of the charity.
Campaigners, including Mind, say the drug
should be withdrawn from sale, but GSK and the
Medicines and Healthcare products Regulatory
Agency (MHRA) have defended it, arguing that its
benefits outweighed the risks.
However the MHRA has said that too many drugs
of this class, SSRIs (selective serotonin
re-uptake inhibitors), have been prescribed, and
has warned that they should not be given to
under-18s.
The MHRA also said that an increase in
suicidal thoughts among users of Seroxat “cannot
be ruled out.” The new study suggests that such
an increase should have been apparent from the
beginning.
Sales of paroxetine have fallen sharply in
the UK in the past three years after concerns
about it were highlighted by the media.
A team led by Ivar Aursnes of the University
of Oslo looked at 16 studies in which paroxetine
had been compared with placebo, including
previously unpublished data.
The trials covered a total of 190
patient-years of use of the drug and the results
were published in the journal BMC
Medicine.
Ms Corlett of Mind said: “This study would
seem to be an extremely worrying addition to
growing evidence raising serious concerns over
the safety of paroxetine.
“Mind's own research has revealed that 50 per
cent of the people who contacted us to report a
reaction to Seroxat had experienced feelings of
wanting to self-harm or commit suicide, and 58
per cent of these people said they had not
experienced these feelings before they started
taking Seroxat.”
GSK said: “We will review this study
carefully. However, these conclusions in no way
reflect the picture that has been built up about
the benefits and risks of paroxetine in adults
through an extensive clinical trials programme
involving 24,000 patients.”
The MHRA said that while a modest increase in
suicidal thoughts and self-harm could not be
ruled out for those on SSRIs, there was
insufficient evidence to conclude that there is
any marked difference between different SSRIs,
or between SSRIs and other antidepressants.
The Norwegian group concluded: “The increased
suicidal activity seen in children and
adolescents on certain antidepressant drugs may
well be present in adults. The restrictions in
the use of paroxetine in children and
adolescents conveyed by regulatory agencies
lately should include usage in
adults.”