Zofran (marketed in generic form as ondansetron) is a drug used to treat nausea and vomiting in patients who have undergone chemotherapy, radiation, or surgery. Although Zofran is only approved by the FDA to be used in these patient groups, doctors have been prescribing it “off label” for decades to treat nausea and vomiting during pregnancy (NVP).
Now, hundreds of women in the U.S. have filed lawsuits alleging that Zofran taken during their pregnancy caused life-altering birth defects in their children, including:
- Cleft palate
- Heart defects
- Musculoskeletal abnormalities (such as club foot)
- Fetal growth restriction (baby does not grow to normal weight)
If you took Zofran during pregnancy and your child suffered from birth defects, contact Dr. Jack Tolliver for information about your legal options.
About Zofran and off-label use
Over 80% of women experience nausea during the first 12 weeks of pregnancy, and over half of pregnant women experience vomiting. Although there are many types of remedies to help alleviate nausea and vomiting during pregnancy, doctors also rely on medications to treat the condition. (Currently, Diclegis is the only medication specifically approved for use by pregnant women.) These treatments can be particularly helpful for women with hyperemesis gravidarum, or extreme nausea that can permanently injure the mother and child.
Zofran, however, is not approved by the FDA to treat morning sickness in pregnant women. Still, doctors have been prescribing it “off label” for morning sickness for decades even though its safety during pregnancy has never been verified.
A 2006 study reported that Zofran passes through the placenta during the first trimester, confirming that it has the potential to influence a baby’s development in utero; in fact, traces of Zofran were found in the fetal tissue of every mother who participated in the study. A 2011 study found that Zofran use during pregnancy doubles the child’s risk of developing a cleft palate. In 2013, the FDA listed Zofran as a “potential safety issue.” Read more about Zofran studies and what they reveal about the drug’s potential to cause birth defects.
The medication’s use during the first trimester is especially concerning since it is the most crucial stage of a baby’s development. It is also the trimester during which the baby is most susceptible to damage from illegal drugs, alcohol, and dangerous medications.
Zofran and its maker GlaxoSmithKline have been under legal scrutiny for many years. In 2013, GSK was involved in a lawsuit alleging that the company promoted off-label use of Zofran and gave doctors kickbacks for prescribing the drug. The suit was settled for a record-breaking $3 billion.
Did you take Zofran during pregnancy?
If you took Zofran or ondansetron during pregnancy and your child experienced birth defects, call Dr. Jack Tolliver for a free case review. As both a medical malpractice lawyer and a former physician, Dr. Tolliver can provide unique insight into your medical history and help you understand whether Zofran may have caused your child’s birth defects. Dr. Tolliver’s firm is exclusively dedicated to helping Kentucky victims of medical malpractice, so contact us today to get the help your child needs to live the healthiest life possible.