Use of Zofran®, Ondansetron Hexal®, Ondansetron Sandoz® (ondansetron) in early pregnancy and risk of birth defects

A Dear Healthcare Professional Letter has been issued by Novartis to inform healthcare professionals of the findings from recently published epidemiological studies related to the risk of birth defects associated with ondansetron. These studies assessed the risk of specific congenital anomalies, including orofacial clefts and cardiac malformations in children born to mothers exposed to ondansetron during the first trimester of pregnancy. 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. Healthcare professionals are advised to take into consideration the above safety information when prescribing Zofran^®, Ondansetron Hexal^® or Ondansetron Sandoz^®. These products are not approved for the treatment of nausea and vomiting in pregnancy, and their use in pregnancy is not recommended. Women of childbearing potential should be advised to use contraception while taking Zofran^®, Ondansetron Hexal^® or Ondansetron Sandoz^® and for 2 days after stopping treatment. Please refer to the letter for details. Published: 23 Sep 2020

Dear Healthcare Professional Letters