Embryo‐fetal safety evaluation of ondansetron in rats

Abstract

Background: Ondansetron is a 5HT3 receptor antagonist, used to mitigate the effects of nausea and vomiting after chemotherapy or surgery. Since nausea and vomiting are common experiences during the first trimester of pregnancy, this antiemetic has been the main drug used during this period. Methods: To evaluate the effects of ondansetron on the embryo-fetal development, which are still very contradictory, pregnant rats were exposed to therapeutic doses of ondansetron (1.7 or 2.5 mg/kg) daily, from gestational day (GD) 6 to 15.Results: No clinical signs of toxicity were observed in dams during the treatment. Although the hemato-biochemical parameters were similar among the groups, histological changes, as well as a reduction in the weight of kidney were found in the treated dams. After fetal examination, no visceral and skeletal abnormalities were observed in treated fetuses. Conclusion:In conclusion, therapeutic doses of ondansetron have low teratogenic potential in rats. These data provide important information about the drug safety during pregnancy.

Response to Dr. Wise and Dr. DeSesso's comments on “Maternal–fetal safety evaluation of an aqueous extract of Casearia sylvestris leaves in rats”

“…Regarding the number of animals per group, we selected an experimental sample size of 10, as it is a common practice utilized in other previously published teratology articles from our research group (Reis et al, 2023). In this study, 40 females and 10 males were mated to obtain the litters.…”