Despite having never been approved for use during pregnancy, Zofran is currently the top-selling morning sickness drug in the US. More than 1 million women are prescribed the drug every year, many in their first trimester, when developing fetuses are most susceptible to harm. Use of Zofran during the first 10 weeks of pregnancy has been linked to the development of congenital cardiac malformations and cleft lip and cleft palate deformities.
Zofran is an oral medication prescribed to combat nausea and vomiting that may be caused by surgery, cancer treatments (chemotherapy) or radiation treatments. It works by blocking the 5-HT3 serotonin receptors on the vagal nerves which run from the stomach to the throat and in the “chemoreceptor trigger zone”, meaning, it blocks chemicals (serotonin) in the body that can trigger nausea and vomiting.
Zofran was developed by GlaxoSmithKline (GSK) and approved by the FDA in 1991 to prevent nausea and vomiting caused by chemotherapy and radiation therapy. GSK also promoted off-label use of the drug to treat morning sickness in pregnant women for which it recently paid civil penalties. However, Zofran was never approved for use during pregnancy.
Zofran is listed as a “Category B” medication for pregnancy. Category B indicates that the medication has not been proven safe for use during pregnancy. However, many women have been prescribed Zofran for morning sickness. Nausea and vomiting may persist through pregnancy, but most often occurs during the first trimester when the developing fetus is most vulnerable to damage caused by medications. Studies have shown that the use of Zofran during pregnancy has been shown to cause birth defects, including:
A child or the family of a child who was injured because the mother was given Zofran during pregnancy may be entitled to compensation for damages. Monetary damages awarded to those injured by medications may include coverage of medical costs, lost wages and pain and suffering.
More than 500 families have filed lawsuits against GlaxoSmithKline, the manufacturer of Zofran, over allegations that the company marketed the drug to pregnant women without FDA approval, failed to warn consumers about the risks and even went so far as to hide evidence of these risks (most notably, the strong links between their anti-nausea drug and serious birth defects). These Zofran-related legal claims center on the cause of birth defects and whether the drug maker is liable for injuries sustained by infants whose mothers took the medication while pregnant. If you or your child have suffered an injury as a result of taking Zofran while pregnant, contact us immediately for a free case evaluation today at (800) 229-7704.
Page last reviewed and updated: November 22, 2020