GlaxoSmithKline PLC received initial FDA approval for ZOFRAN (ondansetron) in 1991, a type of prescription drug called an “anti-emetic” (a 5HT3 receptor antagonist), for treatment of nausea and vomiting after chemotherapy, radiation and surgery. Zofran works by blocking a neurotransmitter (serotonin) in areas of the brain that trigger nausea and vomiting.
While GSK never tested Zofran for, nor did FDA approval include, use by pregnant women, it is often prescribed off-label for morning sickness and nausea. Approximately 80% of expectant women experience nausea and vomiting during pregnancy (NVP). The most serious form of NVP, called hyperemesis gravidarum, can lead to malnutrition and dehydration, a dangerous condition for both the mother and child particularly during the crucial first trimester when the baby is developing. GSK identified a new market of patients for Zofran and advertised to doctors and mothers-to-be looking for relief from these symptoms. Pregnant women typically are prescribed a once or twice per day 8 mg tablet (or oral disintegrating tablet) or receive the drug by injection. Approximately one million women take the drug each year and GSK made millions on the drug annually.
The U.S. Department of Justice sued GSK in 2011 for unlawful promotion and failure to report safety data of a number of its drugs, including Zofran. In 2012, GSK pled guilty to illegally marketing Zofran and other medications for off-label, unapproved uses and agreed to pay a more than $3 billion to settle the charges. In the settlement agreement, GSK admitted it "promoted the sale and use of Zofran for a variety of conditions other than those for which it was approved as safe and effective by the FDA.” The settlement was reported to be the largest health care fraud settlement in the U.S. and the largest payment ever by a drug company. Although physicians and other authorized medical professionals may prescribe Zofran for an off-label use, the FDA approval was limited to certain uses and, therefore, illegal for GSK to market Zofran and other listed medications for non-FDA approved uses.
After conflicting study results, a 2014 study of expecting Canadian women prescribed Zofran suggests that mothers who took the drug during their first trimester of pregnancy may be at increased risk for delivering babies with various birth defects, including:
Reported side effects that directly affect the mother include:
Multiple lawsuits have been filed in state and federal court on behalf of , alleging GSK knowingly marketed Zofran to pregnant women without sharing information about possible birth defects, which information the complaints claim GSK had knowledge of since 1992 or before. GSK’s request for the Judicial Panel on Multidistrict Litigation to consolidate all proceedings for to the U.S. District Court Eastern District of Pennsylvania is scheduled for consideration in October 2015.