Parents across the country say mothers were prescribed Zofran without FDA approval.Numerous lawsuits allege children's birth defects caused by off-label use of Zofran. Zofran, a powerful anti-emetic drug, has recently garnered national attention because of the growing number of lawsuits being filed against its manufacturer, GlaxoSmithKline (GSK).
Zofran: The BeginningIn 1991, GSK was given approval by the U.S. Food and Drug Administration for the drug. The approval allowed the drug to be prescribed to patients who were nauseous and vomiting after chemotherapy, radiation, and anesthesia. The FDA did not approve the drug for the treatment of morning sickness, a condition frequently experienced by expectant mothers during the first trimester.
Even though the drug hadn’t been deemed safe for use during pregnancy, GSK began a marketing campaign which indicated to both the public and the medical community that Zofran was safe for both the mother and the unborn child. The drug soon became one of the most frequently prescribed drugs by OB/Gyns.
Birth Defects: Parents File Zofran LawsuitsSince GSK first began marketing their drug to pregnant women, they have allegedly received over 200 reports of birth defects in children born to women who took the drug.
In the last two years, parents across the country began to file lawsuits against GSK, each one alleging that a child’s birth defect was caused by Zofran while the baby was still in utero. Birth defects named in the lawsuits include respiratory distress syndrome, clubfoot, cleft palate, cleft lip, kidney defects, transposition of the greater vessels, atrial septal defects, and ventricular septal defects.
The “Off-Label” Use Of ZofranIn nearly every complaint filed, the parents indicate that the mother was prescribed the drug “off-label”. This term means that the drug was being used in a way that was not specifically noted on the FDA approved label or in the packaging insert.
While the FDA does regulate the label associated with the drug, it does not regulate how doctors choose to prescribe the drug. Doctors are also not required to inform their patients that the drug they have been prescribed is being used off-label.
This doesn’t mean that companies have permission to advertise their drugs for off-label use. In 2012, GSK settled a lawsuit that had been filed by the U.S. Department of Justice. The complaint alleged that GSK had unlawfully promoted several drugs off-label, including Zofran. In the settlement, the company agreed to pay $3 billion in fines.