The European Medicines Agency (EMA) has issued new recommendations on the use of valproate.
The EMA has advised that when prescribed for migraine or bipolar disorder, the drug must not be used during pregnancy. However, when prescribed for epilepsy, it is recognised that for some women, it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.
Regardless of indication, valproate must not be used in female patients from the time they become able to have children unless the conditions of a new pregnancy prevention programme are met. The valproate pregnancy prevention programme requires that patients are assessed for the potential of becoming pregnant; pregnancy tests are carried out before starting valproate and during treatment as needed; patients are counselled on the risks of valproate and the need for effective contraception, and reviews are carried out annually. A new risk acknowledgement form is to be introduced which patients and prescribers should go through at each review to confirm that appropriate advice has been given and understood.
The EMA has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy.