Ondansetron is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery. It is also useful in gastroenteritis. Ondansetron has also been prescribed during pregnancy to reduce symptoms of nausea and vomiting in pregnancy (NVP). NVP is also referred to as “morning sickness”. Ondansetron is commonly sold under the brand name Zofran.
Problem:
Meta-Analysis on the use of ondansetron in pregnant women shows that this drug is likely to cause a slight over-risk of malformations of the face (cleft lip and cleft palate) in children exposed during the first trimester of pregnancy (3 additional cases per 10,000 pregnant women exposed).
Recommendations:
European Medicines Agency (EMA) has amended the package leaflet and the summary of product characteristics (SPC) specialties based on ondansetron in order to show this risk. It should not be prescribed during the first trimester of pregnancy and other therapeutic alternatives are to be preferred during this period.
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