The link between Zofran and birth defects was unknown for more than 20 years after the medication was originally approved for use in some patients, but now the research is piling up on the drug. The findings are troubling for the drug’s manufacturer, GlaxoSmithKline, because they indicate complications due to off-label use of the medication. As the pharmaceutical giant has been known to push for non-approved uses of its products, it faces huge liability resulting from an emerging wave of serious complications in newborns.


Ondansetron, the generic version of the drug, was approved by the FDA in 1991. It is a powerful antiemetic, capable of blocking chemical signals that cause intense nausea. Its capabilities made it a natural fit for patients undergoing chemotherapy and recovering from surgery, which are the only patients the drug is approved for. However, in the pursuit of profit, the drug has been prescribed to pregnant women to treat morning sickness, even though there was scant research done on ondansetron for this purpose.

There are a number of studies related to the medication’s use in pregnant women, and for a while they were conflicting in their results. However, a pair of studies published in the last few years have proven the link between Zofran and birth defects. The first was a 2012 study published by the Center for Birth Defects Research and Prevention. In it, researchers determined that ondansetron use during pregnancy resulted in twice the risk of the child being born with a cleft palate or lip. The second study, published in the December 2014 edition of American Journal of Obstetrics and Gynecology, concluded that ondansetron use by pregnant women doubled the risk of major heart malformations in the newborn.

Heart malformations are a serious concern in young children, as they can result in additional development issues and threaten the child’s life if not treated. And in many cases, they go undetected for years before they cause a sudden medical emergency. Among these complications are septal malformations, which refer to small perforations in the heart’s ventricular walls. With incomplete divisions between heart chambers, the heart struggles to pump blood effectively, which can lead to a host of other medical problems.


GlaxoSmithKline faces enormous liability for its lack of safety research and the unlawful way it promoted ondansetron to pregnant patients. A federal lawsuit managed by the Department of Justice forced the company to admit to illegal drug marketing. As a result, it agreed to pay out a $3 billion judgement as punishment. The company will face additional damages, though, as more and more families are coming forward to sue it for its inexcusable recklessness. Any family that has been harmed by ondansetron use is encouraged to explore their legal options and determine how to pursue compensation from the company.