FDA Warns Against Zofran Use in Pregnancy

The FDA has not approved Ondansetran, better known by its brand name, Zofran, for use in pregnancy. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. Despite being used off-label to treat nausea and vomiting in pregnancy, the FDA warns against Zofran use in pregnancy. 

Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran, especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting. These risks include Serotonin Syndrome, a triad of cognitive or behavioral changes, including confusion, agitation, autonomic instability, and neuromuscular changes. 

We recommend that Zofran should not be taken during pregnancy.

If you are experiencing morning sickness, there is another option to help prevent nausea and vomiting. Doxylamine succinate and pyridoxine hydrochloride, known as Diclegis, is the only Pregnancy Category A, FDA-approved prescription for morning sickness. This anti-nausea medication provides a safer alternative to pregnant women experiencing severe morning sickness. 

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Fertility Centers of New England is here when you need us. Our experienced, compassionate fertility doctors can answer your questions and help you achieve a healthy and successful pregnancy. If you have more questions on why the FDA warns against Zofran use in pregnancy or are having difficulty conceiving,  please contact us with your questions or schedule an initial consultation.