ZOFRAN (Ondansetron) is a powerful drug developed by GlaxoSmithKline (GSK) and approved by the U.S. Food and Drug Administration (“FDA”) in 1991 to treat only cancer patients who suffered nausea and vomiting as a result of chemotherapy or radiation treatment.
Nevertheless, GSK fraudulently marketed ZOFRAN “off label” to pregnant women as a safe and effective treatment for morning sickness (nausea and/or vomiting) without ever having studied the effects of ZOFRAN on a pregnant mother or her growing child in utero.
Numerous studies have found that ZOFRAN can cause serious birth defects when taken during a pregnant mother’s first trimester:
- Atrial Septal Defect: Opening in the septum (wall) between the upper-left and upper-right chambers of the heart (“atria”)
- Ventricular Septal Defect: “Hole in the heart” defect between the lower-left and lower-right chambers (“ventricles”)
- Heart Murmur: Any abnormal or extra sound heard in the heart using a stethoscope (clicking, whooshing, etc.)