Zofran (ondansetron) is an anti-nausea drug approved by the FDA in 1991 to treat nausea in cancer chemotherapy and radiation therapy patients. The drug was widely used and improperly marketed off-label by GlaxoSmithKline to treat pregnancy morning sickness. However, from 1983 to 2013 there were no FDA approved drugs to treat pregnancy morning sickness. In 2012, GSK paid $3 billion to the U.S. Department of Justice for its improper off-label marketing of ZOFRAN and other drugs.
Studies have shown an increase in certain birth defects when ZOFRAN is taken during the first trimester of pregnancy. Hare Wynn is currently investigating the following birth injuries related to ZOFRAN usage during the first trimester of pregnancy:
- Cleft Palate
- Cleft Lip
- “Hole in the Heart” (Atrial Septal Defect) and (Ventricular Septal Defect)
If you or a loved one took Zofran during the first trimester of pregnancy and had a child born with any of these injuries, please contact us. We are currently evaluating claims for litigation.