Mesut Mete1, Beyhan Gurcu2, Fatih Collu2, Ulkun Unlu Unsal3, Yusuf Kurtulus Duransoy3, Mehmet Ibrahim Tuglu4, Mehmet Selcuki3. 1. Department Neurosurgery, Celal Bayar University School of Medicine, Yelken Evleri Sitesi B Blok k:5 d:16 Güzelyurt, Manisa, Turkey. dr.mmete@hotmail.com. 2. Department of Biology, Faculty of Science and Letters Zoology Section, Celal Bayar University, Manisa, Turkey. 3. Department Neurosurgery, Celal Bayar University School of Medicine, Yelken Evleri Sitesi B Blok k:5 d:16 Güzelyurt, Manisa, Turkey. 4. Department of Histology-Embryology, Celal Bayar University School of Medicine, Manisa, Turkey.
Abstract
INTRODUCTION: Antiepileptic drugs (AEDs) are teratogens and confer a risk of congenital malformation. The estimated prevalence of major congenital malformations such as cardiac defects, facial clefts, hypospadias, and neural tube defects in epileptic women is 4-10 %, which represents a two- to fourfold increase in pregnant women compared to the general population. However, there are no clear data for newer drugs. Lacosamide (LCM), a novel AED, is the first of the third-generation AEDs to be approved as adjunctive therapy for the treatment of partial-onset seizures. There are no data on the pharmacokinetics of LCM during pregnancy, and only some published data have reported on its effects during pregnancy. METHODS: In this study, three different doses of LCM (0.12, 0.5, and 1.60 mg in 0.18 mL) were applied under the embryonic disks of specific pathogen-free Leghorn chicken embryos after a 30-h incubation. Incubation was continued for 80 h, at which time all embryos were evaluated macroscopically and microscopically. RESULTS: There was growth retardation in all of the LCM-treated groups. Major malformations increased in a dose-dependent manner and were mostly observed in the supratherapeutic group. CONCLUSION: Based on our data, LCM may cause growth retardation or major congenital malformations. Nevertheless, more extensive investigations of its reliability are needed.
INTRODUCTION: Antiepileptic drugs (AEDs) are teratogens and confer a risk of congenital malformation. The estimated prevalence of major congenital malformations such as cardiac defects, facial clefts, hypospadias, and neural tube defects in epilepticwomen is 4-10 %, which represents a two- to fourfold increase in pregnant women compared to the general population. However, there are no clear data for newer drugs. Lacosamide (LCM), a novel AED, is the first of the third-generation AEDs to be approved as adjunctive therapy for the treatment of partial-onset seizures. There are no data on the pharmacokinetics of LCM during pregnancy, and only some published data have reported on its effects during pregnancy. METHODS: In this study, three different doses of LCM (0.12, 0.5, and 1.60 mg in 0.18 mL) were applied under the embryonic disks of specific pathogen-free Leghorn chicken embryos after a 30-h incubation. Incubation was continued for 80 h, at which time all embryos were evaluated macroscopically and microscopically. RESULTS: There was growth retardation in all of the LCM-treated groups. Major malformations increased in a dose-dependent manner and were mostly observed in the supratherapeutic group. CONCLUSION: Based on our data, LCM may cause growth retardation or major congenital malformations. Nevertheless, more extensive investigations of its reliability are needed.