According to court documents filed in one lawsuit, Zofran was designed to treat patients who had severe nausea typically associated with cancer treatments such as chemotherapy or radiation. But the lawsuit (Flynn v. GlaxoSmithKline, case number 2:15-cv-00709-PD; filed 2/12/15) alleges GSK not only marketed Zofran “off-label” as a safe and effective treatment for pregnancy-related nausea and vomiting, it did so without even having tested the drug for its potential risks to pregnant mothers and their unborn babies.
“Unlike another anti-nausea prescription drug available on the market - which is FDA-approved in the United States for treating morning sickness in pregnant women - GSK never conducted a single clinical trial before marketing Zofran to pregnant women,” the lawsuit alleges. “GSK simply chose not to study Zofran in pregnant women or seek FDA approval to market the drug for treatment during pregnancy.”
It is not illegal for doctors to prescribe drugs off-label, but it is illegal for drug manufacturers to market their drugs for unapproved uses.
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In addition to the animal studies, the lawsuit claims that by 2000, GSK knew of 32 reports of birth defects linked to Zofran and now has more than 200 reports. But, GSK has allegedly not warned women about the risks of taking Zofran while pregnant.
Flynn alleges that two of her children were born with birth defects after being exposed to Zofran. Her first child, born in 2004, had a congenital heart defect, has undergone surgery to repair the hole and has not thrived physically or developmentally. Flynn’s second child was born in 2006 also with a congenital heart defect and required 24-hour monitoring of her oxygen levels. Flynn argues that if she had known about the risks of Zofran she would not have taken it while pregnant.