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Excerpt
Ondansetron is used for the treatment of nausea and vomiting caused by cancer chemotherapy. Although it is not indicated and little information on fetal safety is available, women are taking this drug for the treatment of nausea and vomiting of pregnancy (NVP). This prospective, comparative, observational study examined whether this drug increases the baseline rate of major malformations.
Women who called counseling service hotlines for information on the safety/risk of drugs were enrolled over a 2-yr period. They were taking ondansetron and were >3 mo pregnant at the time of the call (most were at 5-9 wk gestation). The 2 comparison groups were women exposed to (1) other antiemetics and (2) other nonteratogenic substances or had not used any medication. Interviewers completed an intake form to collect information on the self-assessment of the severity of NVP and any other concurrent medications being taken. The women were contacted 4 to 6 mo after delivery to obtain outcome data. The groups were analyzed to determine rates of live births, miscarriages, therapeutic abortions, stillbirths, major malformations, gestational age at birth, and mean birth weights.
There were 176 women in each group, with no significant differences in the maternal characteristics between the exposed and comparison groups; very few smoked cigarettes or drank alcohol during pregnancy. In the ondansetron group, there were 169 live births and 5 miscarriages; mean gestational age was 38.7 wk and mean birth weight was 3362 g. The group had three cases of hypospadias and one each of double urinary collecting system in kidney, mild pulmonary stenosis, and a duodenal atresia. In comparison group 1, one patient each reported a child with hydrocephalus, a kidney anomaly, and aortic stenosis. In comparison group 2, there was one case of hypospadias and 2 of congenital heart defects. There were no statistically significant differences in the three groups in terms of live births, miscarriages, stillbirth, therapeutic abortions, birth weight, or gestational age.
In this cohort of 176 women who took ondansetron, all during the first trimester of pregnancy, no increase in the rates of major malformations above the baseline were apparent. However, because this was a small sample size, many more cases are required to draw a definitive conclusion.
