Embryo‐fetal safety evaluation of ondansetron in rats

• Published in: Birth defects research Vol. 115; no. 6; pp. 605 - 613
• Main Authors: Reis, Ana Carolina Casali, Jorge, Bárbara Campos, Silva Moreira, Suyane, Stein, Júlia, Perdão, Carolina Barizan, Matos Manoel, Beatriz, Arena, Arielle Cristina
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01-04-2023; Wiley Subscription Services, Inc
• Subjects: Abnormalities; Animals; Antiemetics; Antiemetics - adverse effects; Chemotherapy; Drug dosages; Embryo, Mammalian; Embryos; Evaluation; Female; Fetuses; kidney; Kidneys; Nausea; nausea and vomiting; Ondansetron - adverse effects; organogenesis; Pharmacovigilance; Pregnancy; Rats; Safety; Serotonin S3 receptors; Teratogenicity; Toxicity; Vomiting; kidney; rats; organogenesis; safety; teratogenicity; nausea and vomiting
• ISSN: 2472-1727; 2472-1727
• DOI: 10.1002/bdr2.2154

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.