Zofran Warnings and Pregnancy Category Are False and Misleading

Austin Kirk

By Austin Kirk
Posted July 23, 2015


Due to inadequate and misleading pregnancy warnings provided by GlaxoSmithKline, there is a false impression among consumers and the medical community that Zofran is safe for pregnant women. However, thousands of children through the U.S. may have developed heart defects, oral cleft defects and other congenital malformations that were caused by side effects of Zofran use during pregnancy.

The lawyers at Saiontz & Kirk, P.A. represent families throughout the U.S. who are pursuing a Zofran lawsuit as a result of the drug makers failure to provide adequate warnings and information about the risk that Zofran may pose for unborn children.

GlaxoSmithKline has generated substantial revenue from use of their anti-nausea drug for treatment of morning sickness or HG pregnancies. However, the FDA has never established that Zofran is safe for pregnant women or approved the medication for pregnancy nausea and vomiting. In fact, Zofran is only approved for use to treat nausea and vomiting following cancer treatments or surgical procedures.

Zofran Pregnancy Category

The Zofran warnings list the medication as a “Pregnancy Category B” drug, which means that while animal testing has not shown evidence of harm to fetuses, there have not been adequate human pregnancy testing to confirm that the drug is safe.

Zofran Pregnancy Warnings

Did Your Child Suffer a Birth Defect from Zofran Pregnancy Use?


GlaxoSmithKline has used Zofran’s pregnancy category to portray a false impression that their drug is safe for pregnant women, which is not the case.

Marketing materials distributed by GlaxoSmithKline that were directed at OB/GYNs have emphasized the Pregnancy B Category for Zofran, without providing any information about the existing evidence that the medication may pose a risk for the fetus. This has caused many physicians to mistakenly believe that Zofran was safe in pregnancy.

At a minimum, Zofran should be a Pregnancy Category D medication, which would confirm that there is “evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans”.

Based on hundreds of adverse event reports involving birth defects and studies highlighting the Zofran pregnancy risks, there has been positive evidence of Zofran fetal risk for years.

However, there also appears to be sufficient information to justify a Pregnancy Category X label for Zofran, which would indicate that the risk of using the drug in pregnancy clearly outweighs any possible benefits.

Federal regulations would then require the contraindications section of the Zofran label to state:

Zofran may cause fetal harm when administered to a pregnant woman… Zofran is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Zofran Warnings for Pregnant Women in U.S.

In addition to mis-categorizing Zofran’s pregnancy rating, GlaxoSmithKline has provided false and misleading information for pregnant women in the United States.

Since 1993, the Zofran pregnancy warnings in the U.S. prescribing information has stated:

“Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.” (emphasis added)

These misleading warnings contradict information provided by GlaxoSmithKline in Canada, where the Product Monograph indicates that “the use of ondansetron [Zofran] in pregnancy is not recommended.”

According to allegations raised in lawsuits filed by families throughout the United States, GlaxoSmithKline should issue a Zofran recall or update the warning label to accurately reflect the risk unborn children may face.

Failure to Warn Lawsuits Over Zofran

As a result of GlaxoSmithKline’s apparent decision to place their desire for profits before consumer safety, financial compensation may be available for children throughout the United States through a Zofran birth defect settlement.

The lawyers at Saiontz & Kirk, P.A. are pursuing Zofran failure to warn lawsuits for families of children born with:

  • Cleft Palate
  • Cleft Lip
  • Atrial Septal Defects (ASD)
  • Ventricular Septal Defects (VSD)
  • Other Congenital Heart Defects

All cases are handled by our attorneys under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm. There are no attorney fees or expenses unless money is recovered for your child.


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