A new warning that the controversial antidepressant Seroxat may
increase the risk of suicide in young adults up to the age of 30 is
to be issued in Europe.
Seroxat (known as Aropax in New Zealand) is among the biggest
selling drugs in the world and is taken by between 600,000 and
800,000 people in Britain, of whom "a significant proportion" are
aged under 30, says the manufacturer, GlaxoSmithKline.
The drug has been at the centre of a major Government
investigation of all selective serotonin re-uptake inhibitors
(SSRIs) in Britain over claims they increase suicide and cause
The British Medicines and Healthcare Products Regulatory Agency
(MHRA) launched the investigation last year but its findings have
been overtaken by the European Agency for the Evaluation of
Medicinal Products (EMEA), which licenses drugs for use in the
An agency committee has recommended that Seroxat, already banned
for those under 18 in Britain because of an increased suicide risk,
should be prescribed with extra caution to people aged 18 to 29.
"There is a possibility of an increased risk of suicide-related
behaviour in young adults. As a consequence young adults should be
monitored closely throughout treatment," it says.
The recommendation by the EMEA's Committee for Proprietary
Medicinal Products was made in April and is awaiting ratification by
the EU commission, expected in the northern autumn, when it will
become law in all member states.
The committee added warnings about the risk of withdrawal
symptoms from Seroxat and echoed the ban on prescribing to under-18s
already imposed in Britain.
But it has cleared the drug for continued use in Europe, because
the benefit-risk ratio "remains positive."
The MHRA endorsed the findings of the European agency as
"sensible advice". But it has issued no warning about the dangers of
the drug in people aged 18 to 29.
Richard Brook, chief executive of Mind, the mental health
charity, said: "Why on earth has the MHRA not made more widely known
the danger to young adults? It seems extremely bizarre."
Janice Simmons of the Seroxat Users Group said: "It's appalling.
Unless you tell GPs to monitor people under 30 they won't do it."
The European agency conducted its own review in response to a
request from the MHRA, so prescribing of Seroxat could be harmonised
Fears that Seroxat was unsafe were aired in two BBC television
Panorama programmes in 2002 and 2003 which provoked 67,000 calls and
1400 emails, the biggest response in the programme's history, and
led directly to the Government review.
The MHRA banned Seroxat in under-18s in Britain in June last
year, two weeks after GlaxoSmithKline supplied it with evidence from
trials of Seroxat in children carried out years earlier.
The ban was extended to other antidepressants in the same class,
GlaxoSmithKline faces fraud charges in the United States for
allegedly concealing information the drug caused suicidal behaviour
in children and adolescents.
After banning the drug in children, the MHRA said it would
"urgently examine" the implications of the studies for adults. That
investigation has been widened to include all other selective
serotonin re-uptake inhibitors.
New Zealand keeps a watchful eye
New Zealand authorities are collecting publications on the safety
of selective serotonin re-uptake inhibitors and may seek data from
the European agency after the latest warning on Seroxat (known here
In March, the senior medical adviser for the medicines safety
authority Medsafe, Dr Stewart Jessamine, said the SSRI
antidepressants could continue to be used, with the support of
specialist advice. The decision would be reviewed when more detailed
study results come out.
Last week, Dr Jessamine said extensive warnings were already in
place for use of Aropax, similar to those being proposed in Europe.
Last year, GlaxoSmithKline wrote to NZ doctors advising them to
consider gradually taking patients under 18 off Aropax.
Nearly 1800 6- to 18-year-old New Zealanders took SSRIs last
year, including about 500 on Aropax.
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