Vol.:(0123456789) 1 3 Acta Neurologica Belgica https://doi.org/10.1007/s13760-018-0996-7 ORIGINAL ARTICLE Fetal safety of levetiracetam use during pregnancy Guray Koc 1  · Selda Keskin Guler 2  · Omer Karadas 1  · Tahir Yoldas 2  · Zeki Gokcil 3 Received: 9 May 2018 / Accepted: 25 July 2018 © Belgian Neurological Society 2018 Abstract The aim of this study is to evaluate the efect of levetiracetam treatment during pregnancy on fetus.. The pregnant women with epilepsy (PWWE) who were exposed to levetiracetam treatment during pregnancy in the form of monotherapy or polytherapy were retrospectively evaluated. They were compared with the PWWE who did not use the antiepileptic drug (AED) during pregnancy. A total of 102 pregnancies were examined. While 35 patients never used AED during pregnancy, 30 patients received only levetiracetam therapy, and 37 patients received levetiracetam with at least one combined AED. While no major congenital malformation (MCM) was determined in the group of patients who never used AED and who received levetiracetam monotherapy, 2 MCMs were determined in the group receiving multiple AED therapy with levetiracetam. This study showed that the use of levetiracetam as monotherapy during pregnancy was at the same risk level as the group who never used AED and that the risk increased when it was used as a part of polytherapy. In conclusion, these fndings support the current understanding that LEV may be a feasible option for PWWE. Keywords Pregnant woman with epilepsy · Levetiracetam · Major congenital malformation · Monotherapy · Seizures Introduction Epilepsy is one of the most frequently encountered neuro- logical diseases during pregnancy, and it usually requires the use of antiepileptic drugs (AEDs). The using of AEDs are associated with increased risk of major congenital mal- formation (MCM) and retarded development [1]. Exposure to prenatal AEDs increases the risk of MCM by 1–2% up to 4–9% [2]. There is limited information on the fetal reliability of new generation AEDs. This leads to anxiety among preg- nant women with epilepsy (PWWE) and decreases the rate of drug use. However, it is often necessary to continue treat- ment during pregnancy because seizures are likely to dam- age the mother and fetus [3]. In recent years, the potential teratogenic efect of certain AEDs, especially valproic acid (VPA), has been identifed by many centers. This result has increased transition to lamotrigine (LTG), which is believed to be safe for use during pregnancy while prescribing medi- cations in women with childbearing age, and levetiracetam (LEV) in the recent times. In particular, this situation gains importance in women with primary generalized epilepsy for whom the frst option is VPA [2]. Women feel more secure to use drugs when there are evidence-based results regarding the use of AED during pregnancy [1]. However, there is less information about the new AED [4]. Levetiracetam is a second-generation new AED, and it was approved by the FDA in November 1999 and in Europe in 2000 [5, 6]. It is superior to other AEDs because it is used twice a day, there is less need for monitoring its serum levels, it has no interaction with other AEDs, and it has less efect on cognitive functions [7].Pharmacokinetic studies indicate that it has a linear dose concentration ratio [8]. With these properties, LEV appears to be a suitable drug in the age of childbearing and during pregnancy [3]. In the studies on the safety of the use of levetiracetam during pregnancy, the ratio of MCM in (LEV) monotherapy was found to be 27 (2.2% with 95% CI 1.53–3.22) in a total of 1213 pregnancies. In polytherapy, 34 MCMs (6.3% with 95% CI 4.53–8.65) were found in 541 pregnancies. The risk of MCMs are increased with polytherapy [1, 2, 4, 6, 9–11]. Only two of these studies * Guray Koc gurayerhan@gmail.com 1 Department of Neurology, Gulhane Training and Research Hospital, Ankara, Turkey 2 Department of Neurology, Ankara Training and Research Hospital, Ankara, Turkey 3 Department of Neurology, Faculty of Health Sciences, Physiotherapy and Rehabilitation, Eastern Mediterranean University, Gazi Magosa, Cyprus