Active Ingredient: Gabapentin
Table 2 Open in a separate window Rates of major malformations were similar in both groups, and in addition, none of the 36 women exposed only to gabapentin with no concomitant medications delivered a baby with a major malformation.
The indications for admission included jaundice, low heart rate, hypotonia, hypoglycemia, respiratory distress, jitteriness, diarrhea, fever, and arrhythmia. All of these adverse events were self-limiting and resolved within a few days to a week.
One infant was admitted for seizures in addition to respiratory distress syndrome, jaundice, seizures, and septicemia and was concomitantly exposed to trazodone, venlafaxine, eletriptan, and dimenhydrinate.
Two of the neonates were described as having withdrawal symptoms. The symptoms were self-limiting and resolved within a few days to a week.
Birth weight and preterm birth. Table 3 lists the details of the malformations identified in 7 infants exposed to gabapentin, including doses taken, concomitant medications, and other factors possibly exerting an influence on outcomes.
In the comparison unexposed group, 5 infants had malformations, which included 2 with ventricular septal defects, a dysplastic kidney identified as requiring a transplant, bladder exstrophy, and bilateral hexadactyly plus bilateral colomba in both optic nerves.
Of the 223 women exposed to gabapentin, 142 were exposed in the first trimester only and had been taking it before becoming pregnant, 10 in the first and second trimesters only, 1 in the second trimester only, 1 in the third trimester only, 1 in the second and third trimesters only, and 59 before and throughout pregnancy.
We did not have details of trimester exposure for the 9 remaining cases; however, none of these infants were noted as having a major malformation or any other adverse outcome.
However, this is a small number when considering the possibility that there are probably thousands of women of childbearing age taking this drug worldwide. There was no increased risk for major malformations, which is consistent with data from previous studies.
Both outcomes involve an increased risk of morbidity and mortality of the newborn.
However, not all of these neonates presented with symptoms, as some were admitted for observation, which is the policy for infants who have been exposed to psychotropic drugs throughout pregnancy in some institutions anecdotal information.
Patients experienced symptoms similar to those that develop with benzodiazepine withdrawal and were taking gabapentin for as little as 3 weeks to as long as 5 years.
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