Ondansetron Birth Defects Discovered in Clinical Trials

ondansetron birth defects

Ondansetron, also known as Zofran, was initially approved by the Food and Drug Administration (FDA) in 1991. Ondansetron treats nausea and vomiting symptoms in chemotherapy patients. Despite this, doctors prescribe it off-label to pregnant women suffering severe morning sickness symptoms. It helps quell nausea and vomiting in expectant mothers, but adverse reactions, including ondansetron birth defects, are now linked to Zofran.

Signs of Toxicity with Zofran Use

Before the drug’s FDA approval, scientists tested Zofran on animals for toxicity and drug safety. In preclinical teratogenicity studies conducted during the 1980s, Zofran’s manufacturer, GlaxoSmithKline (GSK), reported no harm to rat or rabbit fetuses exposed to ondansetron.

Despite these claims, studies conducted by GSK in the early 1980s also found signs of toxicity, premature births, intrauterine fetal deaths, and incomplete bone growth. These ondansetron birth defects were noted in a February 2015 civil case: Tomisha LeClair vs. GlaxcoSmithKline LLC.

These studies discovered Zofran’s potentially negative effects on a developing fetus. Despite this evidence, GSK didn’t disclose this information to consumers. Instead, the company began marketing Zofran for morning sickness relief. This is illegal because Zofran isn’t FDA-approved for that specific use.

Ondansetron Birth Defects Vary Widely

Other studies about Zofran’s side effects during pregnancy produced interesting results. A 2006 study by Clinical Pharmacokinetics found ondansetron crosses the placental barrier, exposing the fetus to significant Zofran concentrations. Forty-one patients received ondansetron in their first trimester to measure placental transfer rates. However, the report also noted further studies were needed to determine Zofran’s developmental impact on babies.

Another Clinical and Molecular Teratology study examined data from the National Birth Defects Prevention Study. Researchers studied whether nausea and vomiting during pregnancy or its treatment caused certain birth defects. The study linked ondansetron use and increased risk of cleft palate. Other possible ondansetron birth defects include heart damage, kidney defects, cleft lip, and clubfoot.

Parents File Lawsuits Over Ondansetron Birth Defects

Several Zofran lawsuit claims were filed since these studies were published. Common claims include falsely marketing Zofran as safe during pregnancy, insufficient warning labels, and paying medical professionals to promote ondansetron.

What You Can Do

Raising a child with a congenital birth defect creates many obstacles for families. Kids usually need several surgeries to repair deformities, which can financially impact any household. Parents and kids face extra stress due to worrying about a loved one’s health. If you or someone you know took Zofran while pregnant and your child suffered a birth defect, you may be entitled to compensation. Contact an attorney to discuss filing your ondansetron birth defects claim today.

Jared Heath

Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.