Teratogenic Potential of Third-Generation Antiepileptic Drugs: Current
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Pharmacological Reports 71 (2019) 491–502 Contents lists available at ScienceDirect Pharmacological Reports journal homepage: www.elsevier.com/locate/pharep Review article Teratogenic potential of third-generation antiepileptic drugs: Current status and research needs K.P. Singh*, Niharika Verma Neurobiology Lab, Department of Zoology, University of Allahabad, Allahabad, India A R T I C L E I N F O A B S T R A C T Article history: The aim of this review was to scrutinize the current literature available on teratogenic safety of third- Received 28 August 2018 generation antiepileptic drugs (TGAEDs) considering their clinical implications and to highlight for Received in revised form 27 December 2018 further research need in the interest of the diseased population in general and women with epilepsy in Accepted 29 January 2019 particular. For evaluation of the teratogenic potential of TGAEDs, this review summarized the existing Available online 31 January 2019 information on controlled clinical trials conducted by the pharmaceutical companies, case reports, scholarly articles (prospective and retrospective studies), and experimental tests carried out so far. Keywords: Firstly, clinical reports have reviewed on each drug followed by non-clinical studies reported hitherto. Antiepileptic drugs The Pub-Med and Google search engine was used to explore the relevant articles with pertinent Pregnancy Teratogenicity keywords like pregnancy, epilepsy, seizures, women with epilepsy, antiepileptic or anticonvulsant drugs, fi Birth defects rst-second/new and third/ newest generation antiepileptic drugs, teratogenicity, teratological potential, Congenital anomalies birth defects, congenital anomalies, epilepsy and pregnancy registries, malformation surveillance program. The search was also carried out by the individual name of 20 third-generation AEDs. This review declared that although much research has been carried out on clinical and non-clinical implications for the assessment of the teratogenic potential of FGAEDs and SGAEDs, reports on the teratogenic safety of TGAEDs are still limited. It is concluded that there is an urgent need to exaggerate a large number of clinical intervention trials/reports and experimental studies to draw a definite conclusion for the teratogenic safety of TGAEDs. This is a pioneer attempt by our laboratory to review the teratogenic potential of third-generation antiepileptic drugs. © 2019 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier B.V. All rights reserved. Contents Introduction . 492 Search strategy and inclusion criteria . 493 Characteristics of the third generation AEDs . 493 Current status and teratogenic safety of third-generation AEDs . 493 Eslicarbazepine acetate (ESL) . 493 Clinical studies . 497 Animal studies . 497 Pregabalin (PGB) . 498 Clinical studies . 498 Animal studies . 498 Rufinamide (RUF) . 498 Clinical studies . 498 Animal studies . 498 Lacosamide (LCM) . 498 Clinical studies . 498 Animal studies . 498 * Corresponding author. E-mail addresses: [email protected] (K.P. Singh), [email protected] (N. Verma). https://doi.org/10.1016/j.pharep.2019.01.011 1734-1140/© 2019 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier B.V. All rights reserved. 492 K.P. Singh, N. Verma / Pharmacological Reports 71 (2019) 491–502 Stiripentol (STP) . 498 Clinical studies . 499 Animal studies . 499 Clobazam (CLB) . 499 Clinical studies . 499 Animal studies . 499 Brivaracetam (BRI) . 499 Clinical studies . 499 Animal studies . 499 Fosphenytoin (FPHT) . 499 Clinical studies . 499 Animal studies . 499 Retigabine (RTG) . 499 Clinical studies . 499 Animal studies . 499 Safinamide (SAF) . 499 Animal studies . ..