It is well-known that use of antiepileptics during pregnancy can cause malformations in the foetus. A recent review of data from two birth registers has reinforced the suspicion concerning the antiepileptic topiramate1.
The review showed that use of topiramate during the first trimester of pregnancy may cause increased risk of cleft lip and palate, hypospadias and malformations in other parts of the body.
This new knowledge will soon be added to the summary of product characteristics and the package leaflet for topiramate.
Topiramate is approved for treatment of epilepsy and prophylactic treatment of migraine, but topiramate must not be used for the latter during pregnancy.
The birth registries are the North American Antiepileptic Pregnancy Registry (NAAED) and the UK Epilepsy and Pregnancy Register.