Zofran: Pregnancy & Birth Defects
What is Zofran?
Zofran (common name ondansetron) is a prescription drug developed by GlaxoSmithKline (GSK) to treat symptoms of nausea in cancer patients as a result of surgery, chemotherapy, and/or radiation. However, Zofran has been prescribed by some physicians to treat nausea and vomiting in pregnant women, which may have caused birth defects—including malformations of the mouth (cleft lip or cleft palate), heart defects and other birth defects—in their children.
The Food and Drug Administration (FDA) has not approved Zofran for the treatment of nausea during pregnancy, and the drug is not labeled for use to combat nausea in pregnant women in the United States.
Hissey Kientz is currently taking cases and offering a free case evaluation if you have taken Zofran during pregnancy and your child has suffered birth defects from Zofran use.
Zofran Birth Defects & Side Effects
Infants born to mothers that took Zofran during pregnancy may have malformations of the mouth (cleft lip or cleft palate). These side effects can range from visible facials marks to severe developmental issues, some of which can cause difficulty eating or breathing.
Other birth defects reported in the FDA’s Adverse Event Reporting System (FAERS) include musculoskeletal anomaly, jaundice, heart murmurs, and other forms of heart defects.
A study by the National Center for Biotechnology Information found that taking Zofran during pregnancy could double the chances of a baby being born with a cleft palate.
Another study found evidence that Zofran can cause issues with the development of an infant’s heart. Life threatening complications can occur during pregnancy, birth, or the duration of the child’s life as a result of these heart-growth defects. Some heart defects can result in premature death.
Furthermore, at least one study showed a doubling in the risk of a major birth defect, premature birth and shorter birth length related to the use of ondanestron (the common name for Zofran). Yet another study found data to suggest an increased risk of congenital heart malformation if the infant was exposed to Zofran in the first trimester of pregnancy.
If you’ve taken Zofran during pregnancy and your child was born with birth defects including malformations of the mouth (cleft lip or palate), heart defects, skeletal issues, heart murmurs, jaundice or other similar side effects relating to the developmental health of an infant, you may have grounds to file a lawsuit. For information about whether you may have a case, contact the attorneys at Hissey Kientz, LLP by filling out the contact form on this page.