01.12.2023 - notice within the graduated plan procedure (“Stufenplanverfahren”)

In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October 2023 on medicinal products containing topiramate. This concludes the European risk assessment procedure in accordance with Article 31 of Directive 2001/83/EC for medicinal products containing topiramate.

Available in German only:

13.10.2023 - CMDh position

Concerning the risk evaluation for Topiramate, the PRAC recommendations were sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which endorsed them and adopted its position on 11 October 2023. These measures will now be implemented in all Member States where topiramate-containing medicines are authorised.

01.09.2023 - PRAC recommendation

EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. Topiramate is already known to cause serious birth defects when used during pregnancy.

02.09.2022 - Procedure started

EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during pregnancy. Topiramate is a medicine used in the EU for the treatment of epilepsy, prevention of migraine and, in some countries, in combination with phentermine for body weight reduction.

Further information

Details on the procedure can be found on the website of the European Medicines Agency (EMA):