12.01.2024 - PRAC recommends precautionary measures

Precautions are recommended by PRAC due to the potential risk of neurodevelopmental disorders in children conceived by fathers who have taken valproate-containing drugs.

The results of the review of the retrospective observational study can be found under the following link:

09.11.2018 - Educational material on medicinal products containing valproate

The use of valproate during pregnancy is associated with a significant risk for the occurrence of serious birth defects and developmental and learning problems. To inform about these risks and to ensure safe use of valproate, regulatory approved educational material is available.

20.06.2018 - European Commission final decision

In its notice of 20 June 2018, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2018) 3623 final of 31 May 2018.

27.03.2018 - CMDh position

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has recommended new measures to avoid valproate exposure of unborn babies in the womb.

09.02.2018 - PRAC recommendation

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is recommending new restrictions to avoid exposure of babies to valproate in the womb; babies exposed to valproate are at risk of congenital malformations and developmental problems.

14.03.2017 - Procedure started

The BfArM issues information on the initiation of a safety review by the European Medicines Agency (EMA) to review the use of medicinal products containing valproate in girls and women who are pregnant or of childbearing age.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Valproate and related substances

To the risk assessment procedure (available in German only)