Seroxat
could cause young people under the age of 18 to commit
suicide, say the Government, and doctors should stop
prescribing it.
The unprecedented warning from the
Government's regulatory authority comes after it was revealed
that early clinical trials carried out by the antidepressant
drug's manufacturers prove Seroxat can cause children and
teenagers to self harm or even attempt suicide. But while the
Medicines and Healthcare products Regulatory Agency (MHRA)
warn patients under the age of 18 taking Seroxat to seek
advice from their GP, they say Seroxat is still safe for
adults.
Campaigners in Gloucestershire, who have been
calling for the drug to be banned since last year, have
welcomed the decision.
In what has been called 'a
severe dressing down,' the MHRA's decision will come as a huge
blow for drug giant GlaxoSmithKline, which continues to claim
Seroxat is a safe and effective drug prescribed to millions of
patients each year.
In a statement, the MHRA's
Chairman, Professor Alasdair Breckenridge, said: " It has
become clear that the benefits of Seroxat in children for the
treatment of depressive illness do not outweigh these
risks."
In the last year, around four million
prescriptions were issued and an estimated 8,000 patients
under 18 years were treated with Seroxat.
Although
Seroxat is not licensed by the MHRA for children, GPs are
allowed to use their own judgement to prescribe it when
necessary.
Faye Elliott, founder of the Gloucestershire
Seroxat Support Group, said: "Although we have successfully
succeeded in forcing GSK to admit that Seroxat can cause self
harming and suicidal thoughts in young people under the age of
18 years, we need for them to go that step further to admit
that it can also cause these very same problems in
adults."
Gloucester MP, Parmjit Dhanda, said: "This is
a severe dressing down for GSK. This decision could save
lives."
While the MHRA are warning all young patients
using Seroxat to contact their GPs, an expert group of the
Government's Committee on Safety of Medicines will be looking
into what dangers Seroxat may pose for
adults.
Professor Ian Weller, chairman of the expert
group, said: "At present the evidence is not sufficient to
confirm a causal association between SSRIs and suicidal
behaviour in adults.
"The benefits of taking Seroxat
are well established and patients over 18 years and those who
are benefiting from Seroxat should not be frightened into
stopping their medication."
No comment was available
from GSK.
n It is essential that anyone taking Seroxat,
whether child or adult, should not stop taking the
drug.
If you are concerned about the effects of
Seroxat, please contact your GP or NHS Direct on 0845 46
47.
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