Abstract

BackgroundPregabalin (PGB) was approved as new anti-epileptic drugs with little information about its teratogenic effect.Aim of the workto evaluate the developmental toxicity of PGB.Materials and methods60 pregnant albino rats were divided into three groups. PGB (500 mg/kg body weight/day) was given to group II, PGB (1250 mg/kg body weight/day) was given to Group III and no medications were given to group I. The pups were normally delivered. Liver, kidney and heart specimens were prepared for histological, immunohistochemical, and morphometric studies.ResultsA dose of 500 mg of PGB had minimal toxic effects in the form of mild collagen deposition and moderate positive caspase-3 immunoexpression. PGB dose of 1250 mg/kg induced gross toxic effects in form of degenerated cardiac myofibres, ruptured blood vessels, vacuolations in the renal cortex, fibrosis and strong positive caspase-3 immunoexpression.ConclusionPGB at dose of 500 mg/kg revealed minimal toxic changes. PGB cause embryotoxicity in a dose-dependent manner, as the higher dose induced more degenerative changes.

Highlights

  • Maternal exposure to chronic illness or exposure to some medications or toxins during the early trimesters of pregnancy causes serious changes in embryogenesis [41].The incidence of congenital malformations has increased because of the use of traditional anti-epilepticSeveral antiepileptic drugs (AEDs) can transport through the placenta from the maternal face to the fetal face circulation [40]

  • In July 2004, the European Commission approved PGB for the treatment of several forms of neuropathic pain associated with diabetes or spinal cord injuries and fibromyalgia, and in the same year, it was approved as supplementary therapy for epilepsy by the American Food and Drug Administration (FDA) [33]

  • Effect of 500 and 1250 mg/kg/day of PGB on the fetal body weight, maternal body weight, relative liver, relative kidney, and relative heart weights The fetal body weight of the low-dose PGB treated group showed an insignificant reduction when compared to the control group

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Summary

Introduction

Maternal exposure to chronic illness or exposure to some medications or toxins during the early trimesters of pregnancy causes serious changes in embryogenesis [41].The incidence of congenital malformations has increased because of the use of traditional anti-epilepticSeveral antiepileptic drugs (AEDs) can transport through the placenta from the maternal face to the fetal face circulation [40]. Maternal exposure to chronic illness or exposure to some medications or toxins during the early trimesters of pregnancy causes serious changes in embryogenesis [41]. The incidence of congenital malformations has increased because of the use of traditional anti-epileptic. Several antiepileptic drugs (AEDs) can transport through the placenta from the maternal face to the fetal face circulation [40]. In many cases the concentration of AEDs in the fetal blood becomes higher than in the maternal blood, this may be the principal cause for embryotoxicity and elevated teratogenic potential [50]. Pregabalin (PGB) is the most recent addition to the list of newly approved AEDs [33]. Pregabalin (PGB) was approved as new anti-epileptic drugs with little information about its teratogenic effect

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