Zofran (ondansetron) has been hailed as the most-prescribed pharmaceutical treatment for morning sickness. However, the U.S. Food and Drug Administration never approved the drug for that use. Families of children who suffered birth defects after mothers took Zofran while pregnant have sued GlaxoSmithKline over allegations that it marketed the drug to pregnant women without FDA approval and failed to warn about risks.
Heart defects, cleft palate, skull deformities — these are some of the birth defects mothers say resulted from their use of the anti-nausea drug Zofran during pregnancy. As a result, GlaxoSmithKilne (GSK), the company that originally marketed the drug, has been named in more than 500 actions in federal court.
Zofran Prescribed for Morning Sickness – Without FDA Approval
In 1991, the FDA approved Zofran to help cancer patients with nausea and vomiting after chemotherapy or radiotherapy treatments or surgery. Some doctors whose patients suffered from morning sickness began prescribing Zofran to treat symptoms, even though it lacked FDA approval for that use. Because the medicine appeared to relieve symptoms, Zofran became popular.
Lawsuits allege GSK saw Zofran gaining popularity for morning sickness and began promoting it for that purpose, despite the fact that it’s illegal to promote drugs for off-label use.
Birth Defects Mentioned in Lawsuits
- Heart defects, including septal defects (holes in the heart)
- Cleft lip
- Cleft palate
- Club foot
- Craniosynostosis (skull deformities)
If you were prescribed Zofran for morning sickness while you were pregnant, we can help. Contact our team of lawyers at McEldrew Purtell immediately for a free case consultation.