Zofran, known generically as ondansetron, is an anti-nausea drug that is prescribed “off-label” to treat severe morning sickness during the first trimester of pregnancy; however, Zofran is not approved for use during pregnancy, and use of the drug by pregnant women has been linked to an increased risk of birth defects.
Langdon & Emison represents women and families across the United States whose children were born with a defect as a result of Zofran use during pregnancy. If you took Zofran during the first trimester of pregnancy and your child was born with a defect, you may be entitled to compensation.
What is Zofran?
Zofran is a prescription drug approved by the U.S. Food and Drug Administration to treat patients who experience nausea and vomiting from surgery or chemotherapy and radiation treatments; however, increasingly doctors have prescribed Zofran “off-label” to treat extreme morning sickness during the first trimester of pregnancy. Zofran was developed by GlaxoSmithKline (GSK) and approved in the United States in 1991.
What birth defects are linked to Zofran use during pregnancy?
Recent studies have linked a number of birth defects to Zofran, including but not limited to:
- Structural heart defects, including heart murmur or hole in the heart.
- Cleft palate.
Zofran is not approved for use during pregnancy, but by 2013, more than 1 million pregnant women per year were using Zofran. In the last decade, Zofran has been used more commonly to treat symptoms of severe morning sickness such as uncontrollable vomiting requiring hospitalization, severe dehydration and weight loss, nutritional deficiencies, and other symptoms that pose serious risks to the mother and fetus.