Zofran (ondansetron) is an anti-nausea drug developed by GlaxoSmithKline to treat nausea and vomiting in patients undergoing chemotherapy and surgery. It blocks the actions of chemicals in the body that can trigger nausea and vomiting.
Zofran is considered a Category B drug for use in pregnant women by the United States Food and Drug Administration (FDA), which indicates there is little controlled data on the effect of the drug on an unborn child. The FDA never approved Zofran to treat morning sickness and nausea while pregnant, but the drug has been used “off-label” by pregnant women since it was introduced.
Recent studies have shown that Zofran significantly increases the risk of certain types of birth defects when taken during pregnancy. Zofran has been shown to increase the risk of these birth defects:
- Heart defects, including septal defects or holes in the heart
- Craniofacial defects, including cleft palates
- Kidney malformations
If you or a loved one used Zofran for nausea or morning sickness while pregnant and had a baby born with heart defects, cleft palate, or cleft lip you may be entitled to compensation. If you need help figuring out your rights, contact one of the Zofran attorneys at Goldblatt Singer. We have collected millions of dollars for victims of dangerous drugs.