Even though Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss. Now, recent studies have shown that expecting mothers who took Zofran are at a higher risk for delivering children with the following birth defects:
- Heart defects, including septal defects or holes in the heart
- Craniofacial defects, including cleft palates
- Kidney malformations
Studies Link Zofran to Increased Risk of Birth Defects
Several recent studies have found that Zofran may be linked to an increased risk of birth defects. For instance, in January 2012, researchers found that mothers who took Zofran or the generic medication ondansetron for morning sickness were at a higher risk of delivering children with craniofacial defects. Specifically, the study found that children exposed to ondansetron during the first trimester of pregnancy were twice as likely to develop cleft palates, and researchers said that further investigation into these findings was warranted.
Then, in February 2013, researchers studied medical reports of more than 600,000 children exposed to Zofran during pregnancy, but found no increased risk of birth defects; however, a group of Swedish researchers reviewing the same medical reports found contradictory results. In their research, they found that women who took Zofran during the first trimester of pregnancy were, in fact, at an increased risk for delivering children with major congenital heart defects, including septal heart defects.
Most recently, a Toronto Star investigation found similar birth defect risks when reviewing medical records for Canadian women who submitted reports to the U.S. Food and Drug Administration’s Adverse Events Report Database. In their investigation, the Star found 20 cases where Canadian women were treated for morning sickness with Zofran and delivered children with various birth defects, such as heart defects and kidney malformations. In addition, the investigation found reports of two infant deaths after exposure to Zofran.
GSK Resolves Civil Liability for Allegedly Promoting Zofran for Off-Label Uses
GlaxoSmithKline has faced claims by the United States accusing the company of promoting various medications, including Zofran, for off-label uses (i.e., uses other than the condition for which it was approved by the FDA). In 2012, these claims were resolved in a civil settlement, though the company denies the allegations made against it.
We maintain a dedicated class action website. Our attorneys represent clients in many different class actions. Contact us for more information. We can help with any further medical complications you might experience.