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<p>Sodium valproate has been authorised since the early 1970’s for the treatment of
epilepsy. It was known at the time of licensing that valproate was associated with
an increased risk of birth defects and it was authorised for the treatment of women
of childbearing potential only where other treatments were ineffective. The authorised
product information (Summary of Product Characteristics or SPC and Patient Information
Leaflet or PIL) contain warnings about the risks associated with use in pregnancy.</p><p>
</p><p> </p><p> </p><p>The Medicines and Healthcare products Regulatory Agency (MHRA)
initiated a Europe-wide review of the risk of developmental disorders in October 2013
following publication of studies which provided further information on the magnitude
and nature of the risk of developmental disorders in children born to mothers who
took valproate in pregnancy. The Europe-wide review, led by the United Kingdom and
the Netherlands, was completed in November 2014 and MHRA is working to fully implement
the conclusions of that review which are binding in all Member States. There will
be a mandatory requirement for all manufacturers to update the valproate SPC and PIL
with strengthened warnings and in addition new educational materials will be provided
to healthcare professionals and patients.</p><p> </p>
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