The attorneys at Kirtland & Packard are investigating potential lawsuits on behalf of mothers who were prescribed the anti-nausea medication Zofran (ondansetron) during their first trimester of pregnancy and delivered children with birth defects. While 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
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.
If you or a loved one suffered any of the adverse affects above after taking Zofran, please call or email us today for a free consultation on your case.