Zofran, or ondansetron hydrochloride, is most commonly available as an oral rapidly disintegrating tablet produced by GlaxoSmithKline to treat nausea and vomiting. It is also available as a solution for injection. The FDA approved Zofran for use as an anti-nausea medication for cancer patients undergoing chemotherapy, radiation therapy, or surgery. Doctors have also prescribed the drug to treat an extreme form of morning sickness, hyperemesis gravidarum, in pregnant women.
The FDA approved Zofran in 1991 to treat cancer patients with nausea and vomiting due to chemotherapy, radiation therapy, or surgery. Zofran works by blocking chemical reactions in the body that trigger nausea and vomiting. It is a serotonin 5-HT3 receptor antagonist.
In 2012, GSK pled guilty to promoting Zofran to doctors for the off-labeled use in the treatment of morning sickness in pregnant women. Zofran is not labeled for use in the U.S. or Canada to treat severe morning sickness; it is only approved to treat cancer patients.
Birth Defects and Zofran
Studies have shown an increase risk of children being born with a cleft lip/palate if their mother used Zofran to treat morning sickness during her first trimester.
Zofran has also been linked to other serious health conditions and side effects in children, whose mothers used Zofran while pregnant, including:
- Musculoskeletal anomalies
- Mouth deformities
- Heart defects
- Kidney malformations
The FDA has warned that Zofran can lead to abnormal and potentially fatal heart rhythms such as long QT syndrome and Torsade de Pointes. The drug can also cause serotonin syndrome, which can be potentially dangerous, even deadly, to both the mother and fetus.
McDivitt Law Firm has previously assisted clients with Zofran cases but is no longer taking new cases.