A statement was made on emma4facs wordpress blog that is inaccurate. I have sought clarity from the European Medicines Agency and I have been informed that the MHRA initiated the Europe-wide review following advice from their national expert advisory group - the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines on the emerging data on the risks of neurodevelopmental delay in children exposed to sodium valproate during pregnancy. As well as the important new studies on this issue, the level of concern expressed by patient organisations and individuals in this area, including Registered Charity no: 1116497 Organisation for Anti Convulsant Syndromes( Deborah Mann), FACT ( Emma Friedmann), FACSaware (Branwen Mann), InFACT and FACSA (Janet Williams, Emma Murphy), was an important factor in the decision to initiate the review. European groups in France APESAC ( Marine Martin Lou Passeron, Belgium ( Nathalie Raemdonck Nathalie Rossignol) and Eire Karen Walsh) will also be represented. I would like to thank all those who have contributed to ensuring our voices are heard by medicine regulators and government. Jo Cozens Timothy Noakes Carol Lapidge Vicki Crallan Nicola Hall Karen Buck Glyn Hall Ian McLachlan Vss Janet Stockley-Pollard Joanne M. Branagan Sophie Holmes Des Daughter Diethylstilbestrol Karyse Day Helen Connolly Warwick Sweeney Susan Cole Sarah Barker Kerry Robinson Thank you and keep up the hard work. If you have further contributions please send your comments to Deborah Mann at OACS or to Emma Friedmann at FACT or if you have been exposed to VPA to Branwen Mann.
Posted on: Fri, 16 May 2014 15:47:13 +0000
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