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 CMO Urgent Communication: Safety of
paroxetine
(Tuesday, 10th June
2003)
Prescribing advice on Seroxat for children and adolescents
issued (REF: DH)
The Chief
Medical Officer (CMO) has issued prescribing advice on paroxetine
(Seroxat) following the publication of new evidence on the drug's safety
and efficacy in children and adolescents under the age of 18 years.
Paroxetine is not licensed for use in children but it is used in this age
group outside the licensed indications.
Data from clinical trials
in children and adolescents have been reviewed by an Expert Working Group
on SSRIs and the Committee on Safety of Medicines (CSM). These data do not
demonstrate efficacy in depressive illness in this age group and show an
increase in the risk of harmful outcomes including episodes of self-harm
and potentially suicidal behaviour in the Seroxat group compared to
placebo. Various analyses suggest that the risk of these outcomes is
between 1.5 and 3.2 times greater with Seroxat compared to placebo.
On the basis of these data, the CSM has advised that the balance
of risks and benefits of Seroxat is unfavourable when used to treat
depressive illness in this age group. The CSM has advised that Seroxat
should not be used in children and adolescents under the age of 18 years
to treat depressive illness. The efficacy and safety of Seroxat for
children in other indications has not been established.
Prescribing advice – children and adolescents with depressive
illness:
- Seroxat should not be prescribed as new therapy for patients under
18 years of age with depressive illness
- If a patient is being successfully treated with Seroxat, then the
completion of the planned treatment course should be considered as an
option in the management of the illness
- If a patient is not doing well on Seroxat, change of treatment
should be considered.
When stopping treatment with Seroxat:
Seroxat should not be stopped suddenly because of the risk of
withdrawal reactions. The dose should be reduced very gradually, using
half tablets, and then alternating days, if necessary. If the dose is not
tapered, there is a greater chance of experiencing side effects. For the
majority of people, symptoms go away on their own within two weeks. If
side effects are intolerable on dose reduction or stopping, the dose
should be increased and subsequently reduced more gradually.
Adults:
Paroxetine has been demonstrated to be effective in
adults with depressive illness and the CSM advises that the balance of
risks and benefits of paroxetine remains positive. However, the
implications of the new paediatric data on the safety of paroxetine in the
adult population remains under close review by the CSM and its Expert
Working Group.
Further information on Seroxat for prescribers and
patients is available on the website of
the Medicines and Health Care Products Regulatory Agency (MHRA).
Should you require any additional information, please telephone the MHRA
on 0207 273 0000.
REF: Department of Health, Richmond House, 79
Whitehall, London SW1A 2NS
Department of Health website
Clinnix
is not responsible for the accuracy or availability of information on
external websites.
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