The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed new measures to avoid exposure of babies to valproate medicines in the womb, because exposed babies are at high risk of malformations and developmental problems.
The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy, and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available.
Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met. The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant.
A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
The CMDh agreed with EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures. Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU.
The communication in full is available by clicking here and includes information to patients and healthcare professionals.
You will note that the communication includes a link to a short survey. The survey aims to find out what readers think of the communication and how they use it. Participation in the survey is open to everybody reading the communication. We will use the findings of the survey alongside other initiatives to enhance the reach and impact of our communication.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).