Nearly 200 lawsuits have been filed against GlaxoSmithKline (GSK), maker of Zofran, an anti-nausea and anti-vomiting drug used to treat chemotherapy patients. The drugmaker is accused of illegally marketing Zofran off-label as a treatment for morning sickness in pregnant women. The lawsuits allege Zofran causes birth defects in babies born to women who used the drug while pregnant.
Zofran, which contains the drug ingredient ondansetron, was approved by the Food and Drug Administration (FDA) in 1991. It works by blocking serotonin in the areas of the brain that trigger nausea and vomiting. Between 2002 and 2004, GSK allegedly directed its sales staff to market the benefits of Zofran for treating nausea in pregnant women, despite there being no controlled studies to determine the safety of the drug in pregnant women or in developing fetuses.
Doctors have the discretion to prescribe drugs to treat conditions for which they are not approved, but drug companies are forbidden to promote their medications for so-called off-label uses.
The sales scheme was profitable for GSK. The company raked in $1.4 billion in Zofran sales in 2002 alone. However, GSK’s actions eventually caught up with it. In 2012, the company pled guilty and agreed to pay $3 billion to settle criminal and civil fraud charges for illegal promotion of Zofran and other drugs.
The FDA has received more than 500 reports of birth defects linked to Zofran. Zofran birth defects include cleft palate and septal heart defects.
A total of 193 lawsuits have been filed against GSK involving Zofran birth defects, to date, according to Courthouse News. On Oct. 30, 2015, 16 Zofran lawsuits were filed in Alabama and another 11 were filed in Boston.