Seroxat “not suitable for
Tuesday, June 10, 2003
The commonly prescribed antidepressant Seroxat
(paroxetine) should not be used to treat children and
teenagers under the age of 18, according to latest government
Photo Matthew Munro - Health Media
not licensed for children
The Committee on Safety of Medicines
(CSM) has evaluated new data, which show there is an increase
in the rate of self-harm and potentially suicidal behaviour
when Seroxat is used to treat depressive illness in children
The CSM says it has become clear that
the benefits of using Seroxat on children do not outweigh the
The drug, which is a selective serotonin
reuptake inhibitor (SSRI), was first licensed in the UK in
1990. In the last year, approximately 4 million prescriptions
were written and Seroxat was given to an estimated 8,000
patients under 18.
Questions about the safety of SSRIs
have been raised in the media over the past few years, most
recently in a BBC “Panorama” programme, which was screened at
the end of last year. Following such concerns, the CSM set up
an expert group to look at the drugs, and this met for the
first time in May.
CSM Chair Professor Gordon Duff
said, “Seroxat is not licensed for use in children, but we
know it is used in this age group outside its licensed
indications where prescribers make a judgement on their own
responsibility that it is the right treatment for a particular
“It is therefore important that doctors,
patients and parents are aware of the new advice,” he added.
“Young people under 18 years currently taking Seroxat for
depression should consult their doctor.”
of Health says children or adults taking the drug should not
suddenly stop the treatment and that any changes should take
place under medical supervision.
Professor Ian Weller,
chair of the CSM’s expert group looking at SSRIs, said the
panel would be examining the implications for adults. But he
added there was not enough evidence to confirm a causal link
between Seroxat and suicidal behaviour in adults.
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,” he
MIND Chief Executive Richard Brook, who is also a
member of the expert group, said the new evidence underlined
some young users’ concerns about the drug.
strongly believes that the decision today requires us to move
very quickly forward on the review of Seroxat and other SSRIs
especially given the strength of concern we’ve heard from
people taking these drugs,” he said.
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