Zofran Lawsuit and Recall Timeline

To Mothers Inquiring About Birth Defects in Their Children After Taking Zofran During Pregnancy

In recent months, Spangenberg lawyers have been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries involving

cleft lip, cleft palate and congenital heart defects. We believe there is now strong evidence that Zofran (ondansetron) may be the cause of these defects. The FDA never approved this drug for morning sickness and GlaxoSmithKline (GSK), the maker of this drug, paid a $2 billion settlement in a civil lawsuit that involved allegations that GSK illegally promoted its Zofran drug to be prescribed to expectant mothers.  This settlement did not include payments for injuries suffered due to the use of Zofran. You and your child may be legally entitled to compensation for pain and suffering, medical costs, loss of income, emotional distress and other damages.  

To read more about the Zofran Birth Defect Lawsuit, Click Here


August 2014:A Swedish study investigating the risk of birth defects from Zofran (ondansetron) reports that this drug poses a significantly increased risk for cardiac septum defects in the offspring of women who took Zofran during the first trimester of pregnancy. 

July 2014: American researchers confirm earlier reports that Zofran (ondansetron) crosses the placental barrier during pregnancy in relatively high concentrations (approximately 40% of the maternal plasma levels) after just three oral doses. The authors conclude that the high lipid solubility of Zofran (ondansetron) increases its ability to be taken up into fetal tissue in larger amounts. 

August 2013: Two papers relating to Zofran and birth defects are presented at the International Society of Parmacoepidemiology. The first paper concludes that Zofran (ondansetron) taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. Importantly, the second paper includes the data from the first paper but covered more years and more pregnant woman that the first study and came to an opposite conclusion: There is a doubling of the risk of cardiac malformations. Specifically, there was a significant increase in the prevalence of major congenital heart defects in children whose mothers redeemed a presdription of Zofran (ondansetron) during in the first trimester of pregnancy. 

June 2012: GlaxoSmithKline (GSK), the maker of Zofran, pleads guilty to federal criminal health care fraud charges for violations of the Food, Drug, and Cosmetic Act relating to three of its branded drugs. At the same time, GSK also agrees to pay $1 billion in criminal penalties as well as $2 billion in civil penalties to resolve a federal whistleblower lawsuit that included claims that GSK wrongfully promoted Zofran for off-label promotion for use in expectant mothers, and paying kickbacks to doctors to prescribe Zofran for such off-label use.

This $3 billion dollar penalty is the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States. 

January 2012:The CDC’s Nation Center on Birth Defects and Developmental Disabilities publishes a report finding that Zofran (ondansetron) taken during the first trimester of pregnancy doubles the risk of a cleft palate birth defect.




December 4, 2012:  The FDA issued a Drug Safety Communication in which it stated that brand name and generic versions of Zofran were being recalled in the 32 mg dose (pdf).

Per the alert, the 32 mg IV solution increased a patient's risk of developing QT interval prolongation, or irregular heart rhythm. This abnormal heart rhythm could cause Torsades de Pointes, a potentially fatal heart rhythm.

The alert also reiterated the June 2012 warning that a single IV dose should not exceed 16 mg.

The FDA noted that the 32 mg solution "accounted for less than 1 percent of ondansetron IV sales," so the recall should be completed by early 2013.

July 5, 2012:  The FDA released a podcast (transcript) stating preliminary results of GlaxoSmithKline's study (see September 15, 2011, entry) showed that the 32 mg dose of Zofran could cause QT interval prolongation, which could in turn cause a fatal heart rhythm known as Torsades de Pointes.

"Patients who may be at particular risk for QT prolongation with ondansentron are those with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval," the podcast stated.

July 2, 2012:  The U.S. Department of Justice issued a press release (pdf) stating that GlaxoSmithKline would pay a $3 billion settlement after pleading guilty to, among other claims:

  • promoting Zofran for off-label uses such as morning sickness treatment (since the FDA only approved the drug for chemotherapy-related and post-operative nausea); and
  • paying doctors to prescribe the drug.

June 29, 2012:  The FDA issued a Drug Safety Communication (pdf) in which it stated that the 32 mg dose of Zofran "may affect the electrical activity of the heart (QT interval prolongation)." This could cause some patients to develop Torsades de Pointes, a potentially fatal heart rhythm.

This alert also stated that GlaxoSmithKline was removing this dosage from Zofran labels and that "no single intravenous dose should exceed 16 mg."

January 2012:  GlaxoSmithKline completed its study of Zofran's cardiac risks (pdf).

September 2011: GlaxoSmithKline revised Zofran labels (pdf) to include the following, per the FDA:
  • "Information regarding post-marketing case reports of Torsade de Pointes;
  • Recommendation to avoid use in patients with known congenital long QT syndrome;
  • ECG monitoring recommendation in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation."

September 15, 2011:  The FDA issued a Drug Safety Communication regarding Zofran (pdf). That alert stated that:

  • Zofran may change the heart's electrical activity and that change could cause an abnormal heart rhythm such as Torsade de Pointes; and
  • Zofran's labels would therefore be revised. Per the FDA:

The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.

The FDA also ordered Zofran maker GlaxoSmithKline to conduct QT prolongation studies.

August 2011:  To test Zofran's cardiac risks, GlaxoSmithKline began a study titled "A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects (pdf)."

December 27, 2006:  The FDA approved generic versions of Zofran (pdf).

March 9, 1999:  The FDA issued a warning letter (pdf) to GlaxoWellcome regarding its marketing of anti-nausea drug Zofran.

According to that letter, Glaxo failed to warn consumers about Zofran's adverse side effects while touting its effectiveness with statements such as:

  • "Zofran can,"
  • "24-hour control," and
  • "Prevention of emesis I to 2 days after chemotherapy."

June 24, 1997:  The FDA approved GlaxoWellcome's New Drug Application (see June 22, 1995, entry).

June 22, 1995:  GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride) (pdf @ p.10).

January 5, 1993:  The New York Times reported that the FDA approved a pill form of Zofran (pdf).

January 4, 1991:  The FDA approved Zofran (ondansetron) for chemotherapy-related nausea and vomiting (pdf).