Abstract
Background: In the recent past, many third-generation antiepileptic drugs (AEDs) including Pregabalin (PGB) were launched for the treatment of diverse forms of epilepsy with better efficacy and safety profile than first-and-second-generation AEDs, but their teratogenic safety has not been established so far.
Objective: The present study has been undertaken to evaluate the reproductive and teratogenic potential (external and skeletal) of a novel and third generation AED, PGB in pregnant albino rats.
Methods: In this study, pregnant subjects were exposed to clinically relevant doses (41, 82 and 123 mg) of PGB from gestation days 6-20, and sacrificed on GD-21, and their fetuses were collected and examined to identify the birth defects and skeletal anomalies.
Results: This study revealed that prenatal exposure to PGB induced dose-dependent substantial fetal resorptions, litter size, fetal length and weight; and variety of minor external and internal malformations in fetuses predominant with limbs, tail, eyes, abdomen including hemorrhages, and poor skeletal ossification.
Conclusion: Thus, PGB was found to be teratogenic in rats at equivalent therapeutic doses, hence precaution should be taken before prescribing PGB to pregnant women with epilepsy.
Keywords: Antiepileptic drugs, pregabalin, pregnancy, teratogenicity, birth defects, rat.
Graphical Abstract
Current Drug Safety
Title:Teratogenic Effects of Third-generation Antiepileptic Drug, Pregabalin: An In vivo Study
Volume: 13 Issue: 2
Author(s): Krishna Pal Singh*Kiran Gupta
Affiliation:
- Neurobiology Laboratory, Department of Zoology, University of Allahabad, Allahabad 211002,India
Keywords: Antiepileptic drugs, pregabalin, pregnancy, teratogenicity, birth defects, rat.
Abstract: Background: In the recent past, many third-generation antiepileptic drugs (AEDs) including Pregabalin (PGB) were launched for the treatment of diverse forms of epilepsy with better efficacy and safety profile than first-and-second-generation AEDs, but their teratogenic safety has not been established so far.
Objective: The present study has been undertaken to evaluate the reproductive and teratogenic potential (external and skeletal) of a novel and third generation AED, PGB in pregnant albino rats.
Methods: In this study, pregnant subjects were exposed to clinically relevant doses (41, 82 and 123 mg) of PGB from gestation days 6-20, and sacrificed on GD-21, and their fetuses were collected and examined to identify the birth defects and skeletal anomalies.
Results: This study revealed that prenatal exposure to PGB induced dose-dependent substantial fetal resorptions, litter size, fetal length and weight; and variety of minor external and internal malformations in fetuses predominant with limbs, tail, eyes, abdomen including hemorrhages, and poor skeletal ossification.
Conclusion: Thus, PGB was found to be teratogenic in rats at equivalent therapeutic doses, hence precaution should be taken before prescribing PGB to pregnant women with epilepsy.
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Cite this article as:
Singh Pal Krishna*, Gupta Kiran, Teratogenic Effects of Third-generation Antiepileptic Drug, Pregabalin: An In vivo Study, Current Drug Safety 2018; 13 (2) . https://dx.doi.org/10.2174/1574886313666180402145645
DOI https://dx.doi.org/10.2174/1574886313666180402145645 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |

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