- A new warning that the controversial antidepressant Seroxat
[Paxil] may increase the risk of suicide in young adults up to the age
of 30 is to be issued throughout Europe.
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- Seroxat is among the biggest selling drugs in the world
and is taken by between 600,000 and 800,000 people in the UK, of whom "a
significant proportion" are aged under 30, according to the manufacturer,
GlaxoSmithKline.
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- The drug has been at the centre of a government investigation
of all selective serotonin re-uptake inhibitors (SSRIs) in the UK over
claims that they increase suicide and cause withdrawal problems. The UK
Medicines and Healthcare products Regulatory Agency (MHRA) launched the
investigation last year but its findings on Seroxat have been overtaken
by the European Agency for the Evaluation of Medicinal Products (EMEA),
which licenses drugs for use in the EU.
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- A committee of the agency has recommended that Seroxat,
which banned in under-18 year olds in the UK in June last year because
of an increased suicide risk, should be prescribed with extra caution in
people aged 18 to 29. It says: "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."
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- The recommendation by the EMEA's committee for proprietary
medicinal products was made in April and is awaiting ratification by the
European Commission, expected in the autumn, when it will become law in
member states. The committee also warned about withdrawal symptoms from
Seroxat and echoed the prescribing ban for under-18s.
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- But it has cleared the drug for continued use in Europe
on the grounds that the benefit-risk ratio "remains positive".
The MHRA endorsed the findings of the EMEA, but it has issued no warning
to British doctors about the dangers of the drug in people aged 18 to 29.
TheEMEA conducted its safety review in response to a request from the MHRA,
in order that prescribing of Seroxat could be harmonised throughout Europe.
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- 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: "Its appalling. Unless you tell GPs
to monitor people under 30 they won't do it."
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- Fears that Seroxat was unsafe were aired in two BBCPanorama
programmes in 2002 and 2003. They provoked 67,000 calls and 1,400 e-mails,
the biggest response in the programme's history, and led to the review
by the MHRA. Two weeks after GlaxoSmithKline supplied it with evidence
from trials of Seroxat in children carried out years earlier, the drug
was banned. The ban in under-18s was extended to all other SSRIs, except
Prozac.
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- GlaxoSmithKline is now facing fraud charges in the United
States for allegedly concealing information that the drug caused suicidal
behaviour in children and adolescents.
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- The MHRA is now also examining the implications of studies
with all SSRIs for adults. But the outcome of a key part of that review,
expected in October, has been upstaged by the EMEA's decision. Mr Brook,
who resigned from the MHRA's SSRIs working group earlier this year, said:
"It is extremely difficult to see how the MHRA can come to a different
decision that contradicts EU law. Government announcements on this issue
have perhaps been misleading."
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- The Department of Health failed to respond to requests
for a comment.
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- © 2004 Independent Digital (UK) Ltd http://news.independent.co.uk/uk/health_medical/story.jsp?story=544714
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