Zofran (ondensatron) is a drug that was developed and manufactured by GlaxoSmithKline (GSK) for the treatment of severe nausea caused by chemotherapy used for the treatment of cancer. The drug has undoubtedly helped hundreds of thousands of patients deal with the devastating side effects of chemotherapy. It is a drug that is good at what it does.

Child with cleft lip - By Centers for Disease Control and Prevention

Child with cleft lip – By Centers for Disease Control and Prevention

However, Zofran has also been used, off-label, to help expecting mothers combat morning sickness-related nausea. It is usually only prescribed for very serious cases of nausea by well-intentioned obstetricians. Zofran has not been approved for this use by the FDA and the drug has not been proven safe for pregnant women and their unborn children. In fact, several studies show that Zofran may increase the incidence of birth defects, including cardiovascular malformations and septum defects. According to the 2014 article titled “Use of ondansetron during pregnancy and congenital malformations in the infant” by Bengt Danielsson et al, “the drug should not be used off label for nausea and vomiting in early pregnancy until further large prospective are available” while also linking the drug to cleft palate and heart defects.

Possible effects of Zofran on babies include:

• Cleft palate

• Musculoskeletal deformities

• Holes in the heart

• Low birth weight

• Heart murmurs

• Erratic heart rhythm

Though recent studies are not yet conclusive on the link between Zofran and birth defects, preliminary studies do show a link. For this reason, if you took Zofran during pregnancy and now have a child with a birth defect, please give us a call. We are experienced pharmaceutical attorneys who may be able to help your child get the justice they deserve. No company should promote a possibly dangerous drug for use in expecting mothers when pregnancy risks have not been resolved.