Zofran & Pregnancy
According to several studies, Zofran use has been linked to birth defects—including malformations of the mouth (cleft lip or cleft palate), heart defects and other birth defects—in children of mothers who took Zofran during pregnancy.
GlaxoSmithKline (GSK) developed the prescription drug Zofran to treat symptoms of nausea in cancer patients. However, Zofran has been prescribed “off-label” by some physicians to treat nausea and vomiting in pregnant women.
Zofran & Pregnancy Safety
The U.S. Food and Drug Administration (FDA) categorizes drugs based on the potential to cause birth defects if used during pregnancy. The categories are determined based on a risk-to-benefit ratio of possible harm to the fetus compared to the mother’s health and the quality and adequacy of studies and documentation in both animal and human trials. The FDA prioritizes well-controlled human trials/studies above others.
Zofran: “Category B” Drug
The FDA lists Zofran as “Category B” drug, indicating that animal studies have shown no risk to the fetus and there are no adequate trials in pregnant women.” Category B” drug status is the second-highest rating for drug safety during pregnancy, with “Category A” being the highest (showing well-controlled human studies that show no demonstrable evidence of risk to the fetus).
Prescribing Zofran During Pregnancy
“Off-label” prescribing of Zofran by physicians has occurred to treat morning sickness (generally severe and in the first trimester). The prescription is “off-label” because the FDA approved Zofran for use treatment of cancer patients, not pregnant women.
Nevertheless, given the drug’s “Category B” rating, physicians may determine that the benefit of Zofran outweighs the risk for a particular patient on a case-by-case basis. However, in some cases the patient may not be fully aware that Zofran was not approved for use during pregnancy.
Zofran Studies Show Link to Birth Defects & More
Studies linking Zofran use during pregnancy to birth defects have found specific injuries that could be related to Zofran use.
One study found malformations of the mouth, commonly known as a cleft lip or cleft palate, could be related to Zofran use by mothers while pregnant. These malformations range from visible facial marks to severe developmental issues that can cause difficulty eating or breathing.
The Food and Drug Administration (FDA) has a database for reports of injuries from drug use, called the FDA’s Adverse Event Reporting System (FAERS). Adverse event reports from Zofran use during pregnancy include musculoskeletal anomaly, jaundice, heart murmurs, and other forms of heart defects as side effects of Zofran use during pregnancy.
If you’ve taken Zofran during pregnancy and gave birth to a child with birth defects—cleft lip/palate, heart defects, developmental abnormalities—you may have grounds for a lawsuit.
To find more information about the birth defects linked to Zofran use here. You can complete the contact form on this page for a free case evaluation.
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. Please don’t hesitate to contact us using the contact form on this page, by calling toll-free at 1-866-275-4454, or by email at info(at)hkllp(dot)com.
File a Lawsuit
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 related 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.