Despite Hundreds of Birth Defect Lawsuits, Physicians Continue to Prescribe Zofran ‘Off-Label’

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Doctors continue to prescribe Zofran to pregnant women despite a growing body of information that states that doing so can be dangerous. Technically, prescribing Zofran to pregnant women is what is known as an ‘off-label’ use of the medication. Although Zofran has never been approved for this purpose, GSK began marketing the drug for morning sickness soon after it hit the U.S. market in 1991. However, not long after the company began its marketing campaign, it allegedly began receiving reports from OB/Gyns who noted birth defects in children born to women who had taken Zofran during pregnancy. Women who take the medication during pregnancy gave birth to babies with birth defects, including cleft palates and lips, club foot, heart defects and Skull deformities – a condition in which the skull is abnormally shaped and may not have enough space for the brain. This can cause vision problems, eating issues and mental impairment.

Zofran is an FDA-approved anti-nausea drug that blocks the actions of chemicals in the body that can trigger nausea and vomiting. Zofran is not approved to treat morning sickness in pregnancy. It is approved to prevent nausea and vomiting in patients undergoing certain types of surgery or cancer treatment (chemotherapy or radiation). Although it is commonly prescribed “off-label” for this purpose. According to court documents, GlaxoSmithKline, the manufacturers of ondansetron, knew as early as the 1990s that the medication has the potential to cause birth defects, as the drug passes through the placenta once a pregnant patient takes it. Yet, even armed with the knowledge of the risks to pregnant women and their infants, GlaxoSmithKline didn’t warn the public of its dangers. In fact, the company has been accused of offering “kickbacks” to physicians who prescribe the medication to pregnant women. In addition, GlaxoSmithKline not only marketed Zofran as a safe way to treat morning sickness, but the company also falsified animal studies on the drug, stating that it was safe despite the results showing that it can cause unusual bone growth and toxic illness.

Zofran has been assigned to “Pregnancy Category B” by the FDA, which means animal studies failed to demonstrate a risk to the fetus and there were no adequate and well-controlled studies in pregnant women at the time it was approved. This Zofran pregnancy category was based on a review of less than 200 births. New Zofran pregnancy studies of hundreds of thousands of births show that it may cause fetal harm. From January 1, 1991 to April 30, 2015, the FDA received at least 8,682 reports of adverse events linked to Zofran. Among these, 475 cases involved birth defects includes:

  • Cleft lip
  • Cleft palate
  • Club foot
  • Skull deformities
  • Heart defects
  • Cardiac arrhythmias

Zofran is not currently approved by the United States Food and Drug Administration (FDA) to treat morning sickness. Despite hundreds of birth defect lawsuits, yet Doctors prescribe it to millions of women. In February, 2015, a residence of Norfolk County, Massachusetts, was the first plaintiff to file a Zofran lawsuit after her daughter was born in 2000 with several birth defects.


She was prescribed Zofran during her first trimester to help treat her nausea and vomiting. In 2013, a Danish Study titled “Ondansetron use in early pregnancy and the risk of congenital malformations” found a 2-fold increased risk of heart defects in babies whose mothers used ondansetron in pregnancy. Medical practice guidelines advice physicians to use caution when prescribing Zofran, saying the drug should be used only after all other options for treating morning sickness have been exhausted.

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