The public hearing was part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.
Warnings to young women who might become pregnant that the epilepsy drug sodium valproate could cause birth defects and developmental problems in their babies could have been made public more than 40 years ago, according to campaigners.
- EMA’s press release, 26/09/2017.
- EMA’s Summary of safety concerns and List of Questions for the Public Hearing, EMA/432817/2017.
- Women still not being told about pregnancy risks of valproate, THE BMJ, 22 September 2017.
- Birth defect risks of sodium valproate ‘known 40 years ago’, theguardian, 26 September 2017.
- Valproate risk ‘hidden’ from pregnant women for decades, skynews, 26 September 2017.