The safety committee of the European Medicines Agency is recommending new measures in an effort to limit topiramate exposure during pregnancy, due to concerns about neurodevelopmental delays in exposed offspring. They reviewed available data, including three recent observational studies, which indicate that there may be a two to three times higher risk of neurodevelopmental disorders such as autism and ADHD in offspring exposed to topiramate compared to those whose mothers were epileptic, but not taking any antiepileptic medication. 
Recommendations include educational materials informing both healthcare professionals and patients of the associated risks, as well as a clear warning on the outer medication packaging. The committee is advising that topiramate should only be used for management of epilepsy in pregnancy if there is no suitable alternative.
The management of epilepsy in pregnancy is challenging. All women of childbearing potential on any anti-seizure medication should be advised to take folic acid (at least 1 mg daily) irrespective of pregnancy planning. Women planning a pregnancy or already pregnant should be placed on medication that (a) is suitable for the type of epilepsy and (b) has the lowest risk of teratogenicity or neurodevelopmental effects. Monotherapy is preferable. In certain select circumstances, discontinuation of anti-seizure medication might also be an option.
 

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