Ondanov Use In Pregnancy & Lactation

Pregnancy: The use of ondansetron in pregnancy is not recommended.
In human epidemiological studies, an increase in orofacial clefts was observed in infants of women administered ondansetron during the first trimester of pregnancy. Regarding cardiac malformations, the epidemiological studies showed conflicting results.
Three epidemiological studies in the US assessed the risk of specific congenital anomalies, including orofacial clefts and cardiac malformations in offspring born to mothers exposed to ondansetron during the first trimester of pregnancy.
One cohort study with 88,467 pregnancies exposed to ondansetron showed an increased risk of oral clefts (3 additional cases per 10,000 women treated, adjusted relative risk (RR), 1.24 (95% CI 1.03-1.48)) without an apparent increase in risk of cardiac malformations. A separately published subgroup analysis of 23,877 pregnancies exposed to intravenous ondansetron did not find an increased risk of either oral clefts or cardiac malformations.
One case-control study using population-based birth defect registries with 23,200 cases across two datasets showed an increased risk of cleft palate in one dataset and no increased risk in the other dataset. There was no increased risk of cardiac malformations in this study.
The second cohort study with 3,733 pregnancies exposed to ondansetron found an increased risk of ventricular septal defect, adjusted RR 1.7 (95%CI 1.0-2.9), but no statistically significant increase in risk of cardiac malformations.
Reproductive studies in rats and rabbits did not show evidence of harm to the fetus.
Pregnancy status should be verified for females of reproductive potential prior to starting the treatment with Ondavell.
Females of reproductive potential should be advised that it is possible that Ondavell can cause harm to the developing fetus. Sexually active females of reproductive potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) when using Ondavell during the treatment and for two days after stopping treatment with Ondavell.