Highlights from EMA Pharmacovigilance October meeting

10 October 2014

At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews.

The PRAC recommends strengthening the restrictions on the use of valproate in women and girls. The Committee has recommended further restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

The PRAC also recommended that doctors who prescribe valproate provide women with full information to ensure that they understand the risks and to support their treatment decisions. Valproate is used to treat epilepsy and bipolar disorder. Some valproate medicines have also been used in certain European Union member states to prevent migraine attacks.

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