Changing regulatory advice: European Medicines Agency (EMA) Pharmacovigilance Ruling on the use of sodium valproate in women during pregnancy and the childbearing years.

Impact: Health impacts

Narrative

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) re-opened its 2014 review into the use of sodium valproate in women of childbearing potential. My input was into a professional working group where a number of specific questions were to be addressed in order to assist the Committee in their decision meeting. During discussions I drew on data specifically from our own research conducted at Manchester and that of others internationally. The EMA decision directly references work completed at Manchester.

Category of impact

  • Health impacts
Date
2018

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