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
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.