Eslicarbazepine acetate exposure in pregnant women with epilepsy.

PURPOSE: Epilepsy is a common neurologic disorder requiring continued treatment during pregnancy. Treatment with antiepileptic drugs (AEDs) is needed for seizure control, but the risk of adverse events has to be minimized for both mother and foetus. Available data on pregnancy and foetal/postnatal outcomes following eslicarbazepine acetate (ESL) exposure via parent is herein presented for the first time.

METHODS: ESL's global safety database was reviewed to identify pregnancy cases with exposure to ESL reported up to October 21st, 2017. The EMBASE™ and MEDLINE® databases were searched to identify literature reports of such cases published between May 1st, 2009 and October 21st, 2017.

RESULTS: Overall, 91 notifications of pregnancy were identified, of which 79 involved ESL exposure: 28 during clinical trials and 51 from 8-years of post-marketing surveillance. Thirty pregnancies resulted in live birth without congenital anomalies; in 25 pregnancies the outcome was ongoing and 3 was unknown; 18 cases resulted in abortion (10 spontaneous and 8 induced) and congenital anomalies were identified in 5 cases (no clear relationship with ESL was established). ESL was used concomitantly to other AEDs in 11 of the 15 pregnancies for which the outcome was spontaneous abortion and congenital anomaly. Literature review did not yield additional information.

CONCLUSIONS: Available data are insufficient to draw conclusions regarding ESL use during pregnancy. Although no particular safety problem was identified, ESL exposure during pregnancy will continue to be monitored and evaluated.