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173520
star this property registered interest false more like this
star this property date remove maximum value filtermore like thismore than 2015-01-13
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
unstar this property answering dept sort name Health remove filter
star this property hansard heading Pregnancy: Sodium Valproate more like this
star this property house id 2 more like this
star this property legislature
25277
star this property pref label House of Lords more like this
star this property question text To ask Her Majesty’s Government whether they intend to issue an apology for the failure to inform female patients of the dangers of Valproate in pregnancy and the harm caused to children as a result. more like this
star this property tabling member printed
Baroness Masham of Ilton more like this
star this property uin HL4102 more like this
star this property answer
answer
unstar this property is ministerial correction false more like this
star this property date of answer less than 2015-01-26more like thismore than 2015-01-26
star this property answer text <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>
star this property answering member printed Earl Howe more like this
star this property grouped question UIN HL4101 more like this
star this property question first answered
less than 2015-01-26T12:28:03.67Zmore like thismore than 2015-01-26T12:28:03.67Z
star this property answering member
2000
star this property label Biography information for Earl Howe more like this
star this property tabling member
1850
unstar this property label Biography information for Baroness Masham of Ilton more like this