Zofran's History

While the FDA has yet to issue an official warning about the possible risk of Zofran birth defects, there have been plenty of studies published recently that have examined the potential for Zofran use in pregnancy to interfere with fetal development and cause congenital malformations.

In one large study conducted by the U.S. Centers for Disease Control and Prevention (CDC) and the Slone Epidemiology Center in Massachusetts in 2011, researchers found a two-times increased risk of cleft palate birth defects in babies exposed to Zofran during the first trimester of pregnancy.

In December 2014, a review of Zofran birth defect studies published in the American Journal of Obstetrics and Gynecology highlighted a 2013 study of 900,000 Danish women, which found a “2-fold increased risk of cardiac malformations with ondansetron [Zofran], leading to an overall 30 percent increased risk of major congenital malformations.”

Research has also indicated that Zofran can cross the placental barrier and harm a developing fetus, a risk that was demonstrated in animal studies GlaxoSmithKline conducted in the 1980s, and in 2006, a study conducted by researchers in Hong Kong confirmed the ability for Zofran to pass the placental barrier in human subjects.

A 2014 study found “a 2-fold increased risk of cardiac malformations with ondansetron [Zofran], leading to an overall 30 percent increased risk of major congenital malformations.”

Alleged Zofran Birth Defects

  • Cleft lip
  • Cleft palate
  • Club foot
  • Kidney defects
  • Heart malformations
  • Musculoskeletal defects
  • Mouth abnormalities
  • Fetal growth restrictions
  • Atrial and ventricular septal defects
  • Fetal death
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How Zofran Works

Zofran (ondansetron) belongs to a class of drugs called 5HT3 receptor antagonists, which work by blocking a neurotransmitter in the brain called serotonin to help relieve nausea and vomiting in patients undergoing surgery, or chemotherapy or radiation treatment for cancer. Zofran is manufactured by pharmaceutical giant GlaxoSmithKline, and was approved by the U.S. Food and Drug Administration (FDA) in 1991, but never as a treatment for pregnant women. GlaxoSmithKline, however, saw pregnant women experiencing severe morning sickness as a whole new market for its anti-nausea drug, and has promoted Zofran off-label to expectant mothers for years, despite never having established the safety or effectiveness of Zofran use in pregnancy.

Why Are Zofran Lawsuits Being Filed?

Past lawsuits claim:

  • The FDA has never approved ondansetron (Zofran) for use by pregnant women.
  • GlaxoSmithKline illegally advertised Zofran as a treatment for morning sickness and hyperemesis gravidarum, despite lack of approval.
  • GlaxoSmithKline failed to adequately research the safety of Zofran among pregnant women.
  • GlaxoSmithKline knew or should have known about the potential for Zofran to cause congenital birth defects.
  • GlaxoSmithKline failed to make these risks known to consumers and the medical community, thus preventing women and their families from making educated decisions regarding prenatal health.

Zofran Lawsuit Information

Approximately 80% of pregnant women experience nausea and vomiting during pregnancy, and the most serious form of pregnancy-related nausea and vomiting, called hyperemesis gravidarum, can cause potentially dangerous dehydration and malnutrition in the mother and unborn child. However, what many pregnant women don’t know is that the medication intended to relieve their nausea and vomiting symptoms may actually put their baby at risk for serious and potentially life-threatening birth defects. If you believe your child was adversely affected by side effects of Zofran, you may be entitled to compensation for his or her injuries and medical expenses. Consult an experienced product liability lawyer today to discuss the possibility of filing a Zofran birth defect lawsuit against GlaxoSmithKline.