Zofran, also known generically as ondansetron, is a drug approved by the FDA that is commonly used to treat nausea and vomiting in cancer and surgery patients. Zofran marker, GlaxoSmithKline (“GSK”), began advertising Zofran “off label” as a remedy for nausea and morning sickness in pregnant women. Since then, Zofran has been more frequently prescribed to pregnant women to reduce nausea, although it has not been approved for such use. After taking this medication during pregnancy, some women have given birth to children with severe health defects.
In 2011, the Centers for Disease Control and Prevention published a study, which stated that Zofran doubles the risks of birth defects. In June of 2014, the Toronto Star reported that 20 Canadian women who took Zofran gave birth to children with birth defects. More recent research suggests that Zofran has been linked to a 30% increased risk in birth defects overall and double the risk of giving birth to a child with a heart defect. Other birth defects associated with Zofran include oral clefts, growth restrictions, jaundice, and miscarriage, to name a few. It is estimated that approximately 1 million women every year are given Zofran during their pregnancy.
The FDA currently rates Zofran as a “Pregnancy Category B’ drug. This means that no well-controlled studies have been performed on the effects of Zofran for pregnant women. In 2012, the United States Department of Justice filed suit against GSK for their “off label” marketing of Zofran to women. This lawsuit eventually ended in a $3 billion dollar settlement after GSK plead guilty to charges involving fraud and failure to report data.
If you or anyone you know has experienced medical complications or injuries after taking Zofran please contact the attorneys at Zar Law PLLC, by calling (713) 333-5533.