November 22, 2013

FDA Warns Against Zofran Use in Pregnancy

The FDA has issued an updated warning against Ondansetran, better known by its brand name, Zofran, use in pregnancy discussed in OBGYN News. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. It has been used off-label to treat nausea and vomiting 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 the Serotonin Syndrome which is a triad of cognitive or behavioral changes including confusion, agitation, autonomic instability, and neuromuscular changes. Therefore Zofran should not be taken during pregnancy.

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 nausea and vomiting.

Additional resources:

OB/GYN News: Ondansetran, New and troubling data

FDA Announcement

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Joseph A. Hill, III, M.D. Board-Certified in Reproductive Endocrinology and Infertility