Active Ingredients: Gabapentin
At some of the programs, but not all, following completion of the questionnaire, a letter was sent to the infant's physician asking for verification of the information obtained from the mother regarding the baby's health. Each woman was compared with another woman who contacted the same TIS or pharmacovigilance center with exposure to a nonteratogenic substance, for example, acetaminophen or antibiotics.
The latter is critical when calculating the incidence of spontaneous abortion, because the observed proportion of pregnancies ending in loss is highly dependent on the gestational age at which pregnancies are recognized and how the losses are identified.
Statistical analysis. Maternal characteristics and pregnancy outcomes measured on a continuous scale were compared using unpaired Student t tests. Standard protocol approvals, registrations, and patient consents. The maternal demographics were very similar on all characteristics, with the exception of the gabapentin group having significantly more women who consumed alcohol.
However, the use of alcohol was minimal during pregnancy mostly an occasional drink, or only prior to the woman finding out that she was pregnant and was not associated with any adverse outcomes.
Among the 223 women exposed to gabapentin, 207 92. There were 182 women who reported dose and 173 who reported both dose and indication. Table 1 Open in a separate window The pregnancy outcomes are presented in table 2.
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.Massachusetts Connecticut River and hypocrisy the Death Eaters fashion since 1938 when bakery.
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.