The Nature of the Drug: GlaxoSmithKline developed and marketed Zofran (Ordanstan Hydrochloride) as a treatment for nausea caused by chemotherapy or by drugs taken after surgery. Zofran blocks serotonin, a neurotransmitter that antidepressant drugs act on but that is also associated with upset stomach and vomiting. The latter problem occurs because the 5-HT3 receptor can overreact to serotonin, causing the digestive distress associated with many drugs. The U.S. Food and Drug Administration approved Zofran to help cancer patients suppress nausea after chemotherapy or surgery. GlaxoSmithKline, however, has promoted the drug to treat women’s morning sickness, though the FDA never approved it for that purpose.

The Hazards of Zofran: Zofran’s most serious side effects are birth defects in the offspring of women who took it for nausea while they were pregnant. Children have been born with cleft lips and palates, cleft feet, deafness, mouth deformities, heart defects, skull deformation (craniosynostosis), and disorders of the blood such as high potassium. Some of the birth defects are correctable with surgery, but others must be managed with drugs or medical devices.

Zofran users have also experienced mild or moderate side effects, such as drowsiness, dizziness, nausea, fever, weakness, and diarrhea.
Most Zofran lawsuits have focused on birth defects. They charge that GlaxoSmithKline marketed the drug to pregnant women without its being approved for them.

To Obtain Legal Relief: If you took Zofran while you were pregnant and your child has a birth defect, you may possess valuable legal rights. Attorney Stephen A. Katz is available at (800) 251-3529 for a free consultation, or for legal representation.