Brand Names: Zofran, Zofran ODT, Zuplenz
During the past decade Zofran and Zuplenz have been increasingly used in the United States for nausea and vomiting of pregnancy. The drugs act by blocking the actions of chemicals in the body causing nausea. The patent for Zofran expired in 2006 but Zuplenz was then approved in 2010. The main difference between Zofran and Zuplenz is that Zuplenz tablets will dissolve without water. The drug indication is limited to patients following cancer treatments and surgery. However, the drugs have been routinely prescribed and used “off label” for stomach problems in children and morning sickness in expecting mothers. It has been estimated at 80% of pregnant women consumed a version of Zofran or Zuplenz. In 2012, Glaxo Smith Kline plead guilty to fraud and illegal promotion of several drugs including Zofran and paid a $3 Billion fine as part of the settlement.
Joe Lyon has represented hundreds of individuals harmed by pharmaceutical products nationwide. For questions related to the Zofran lawsuit call for a no cost consultation (800) 513-2403.
Medical Literature Finds Association with Zofran and Birth Defects
Earlier studies on Zofran showed there was no safety issue with the drug. However, fetal safety data was based on less than 200 births. Newer research has called those conclusions into doubt with many questions related to the methodology applied to the data to reach such conclusions.
- In 2013, the prominent New England Journal of Medicine published a study of 2,000 women from a Danish Birth Registry. The study showed that Zofran did not harm the fetus, but the study contained a major flaw in that most of the women took the medication past 10 weeks. Malformations are not though to be produced beyond 10 weeks gestation, so the paper was severely limited in its application.
- Following the NEJM study, the International Society of Pharmacoepidmiology published a paper entitled Ondanestron Use in Early Pregnancy and Risk of Congential Malformations evaluated women in the first trimester. The researchers found that after exposure to ondanestron, children were more likely to suffer a birth defect. Specifically, the strongest association was related heart defects involving cardiac tissue that failed to develop. Notably :
- Atrial septal defects were 2.1 times more likely
- Ventricular septal defects were 2.3 times more likely
- Atrioventricular septal defects were 4.8 times more likely
- In December 2014 , a group of Swedish publish health officials published a paper entitled ” Use of Ondanestron During Pregnancy & Congenital Malformations in The Infant” evaluating a total of 1,349 births. The authors also concluded that there was a statistically significant increased risk of cardiovascular defects associated with Zofran.
- Control study by Sloan Epidemiology unit and Centers for Disease Control found a 2 fold increase for cleft palate for Zofran taken in the first trimester [odds ratio = 2.37 (95% CI, 1.28-4.76).
Types of Zofran Injuries
- Heart Defects, including septal defects (holes in the heart)
- Atrial septal defects
- Ventricular septal defects
- Atrioventricular septal defects
- Cleft Lip
- Cleft Palate
- Club Foot
- Craniosynotosis (skull deformities)
- Kidney Malformations
Basis for Zofran Lawsuit
- Glaxo breached its duty to adequately test Zofran before selling the product for use during pregnancy
- Glaxo failed to warn physicians and patients about the risk of birth defects when taken during pregnancy
- Glaxo promoted Zofran as safe for use during pregnancy when the FDA had not approved the drug for such use
- Glaxo failed to properly communicate the results of animal studies that showed signs of abnormal bone growth and toxicity
- Glaxo failed to properly analyze the available data and safety information on the drug before selling the Zofran for use during pregnancy
In September of 2011, the FDA issues warning about possible QT prolongation and torsade de pointes among people receiving Zofran and called for closer monitoring of patients who may suffer QT syndromes, electrolyte imbalances, or congestive heart failure.
If you or a loved one suffered an injury due to a Zofran injury and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.