GA13APENTIN-INDUCED TERATOGENECITY : IS IT DOSE-DEPENDENT?
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Abstract This study was designed, on experimental basis, as a trial to assess the frequency of occurrence of congenital malformations secondary to the use of gabapentin (Neurontin) during pregnancy and to study the dosefrequency relationship. The study comprised 100 newly getting pregnant female albino rats divided into 5 equal groups: group I (Control group) rats were kept on normal diet, group II rats were kept on the control diet supplemented with gabapentin in a dose about 50% of the maximum recommended human dose (MRHD), group III, IV & V received gabapentin about I, 2 & 4 times of MRHD, respectively. All rats were followed-up till parturition for completion of course of pregnancy. and occurrence of bleeding, and newborn pups were examined for the presence of congenital anomalies. No abnormal course or outcome of pregnancy occurred in groups I & II apart from one rat pup in group II showed delayed ossification of the skull, but administration of gabapentin resulted in abnormal follow-up in 20 rats in groups Delayed ossification was the most frequent effect of exposure to gabapentin, and was encountered in 6 rat pups, post-implantation fetal loss occurred in 5 rats, two rat pups in groups IV had cyclops holoprosencephaly; 5 rats had hydroureter in groups IV & V. and 3 rats had hydrops of urinary tract one in group IV and 2 in group V. There was a positive significant correlation between the increase of dose and frequency of occurrence of anomalies. (r--.0.381, P<0.001). We can conclude that exposure to gabapentin during pregnancy especially through the period of organogenesis is associated with the possibility of loss of pregnancy or of getting a newborn with congenital malformations and that the incidence of such side effects is dose dependent.