Pregnancy: Sodium Valproate

Department of Health written question – answered on 16th October 2014.

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Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

To ask the Secretary of State for Health, when he expects the European Medicines Agency's review of valproate and related substances and their use by pregnant women to report; and if he will make a statement.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of the risk of neurodevelopmental disorders in children exposed to valproate in the womb. PRAC has recommended strengthening the restrictions on the use of valproate. In particular PRAC has recommended that valproate should not be used to treat epilepsy and bipolar disorder in girls, women who can become pregnant or pregnant women unless other treatments are ineffective or not tolerated and that the need for continued treatment should be reviewed regularly. The PRAC recommendations will now be sent to the Member States’ Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for a final opinion in November. Healthcare professionals and patients will be informed of the new advice once the CMDh has reached a final opinion.

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