Paroxetine review makes safety warnings
A number of recommendations
on paroxetine use have been made following a European review of the product by the Committee for Proprietary Medicinal Products and the European Agency for the Evaluation of Medicinal Products.
The review was carried out through a
formal referral procedure made by the UK
following safety concerns. The CPMP has concluded that the risk-benefit
remains positive for paroxetine in the treatment of adults but recommends
changes to product information on an EU-wide basis.
The changes include warnings that paroxetine should not be used in children
and adolescents and that prescribers monitor closely patients at high
risk of suicidal behaviour. These include patients with a known history
of suicidal behaviour or suicidal thoughts
before starting treatment and, possibly, young adults. In addition, prescribers
and patients should be warned about the occurrence of withdrawal reactions
on stopping treatment. These are generally moderate and self limiting
but may be severe and prolonged.
The summary of product characteristics of Seroxat used in the UK already
incorporates these points.
Although health care professionals in the UK have been advised against
using paroxetine, venlafaxine and sertraline in children, the CPMP and
EMEA say that no request has been made for it to review the SSRIs as
a class. |
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