Zofran Lawsuit Timeline Traces Path to Litigation

Published on April 8, 2015 by Sandy Liebhard

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A growing number of Zofran lawsuits have been filed in U.S. courts that allege the drug can cause birth defects if it is used by expectant mothers in their first trimester of pregnancy. While this litigation is only beginning to get underway, concerns about Zofran and birth defects has been building for some time, as is evidenced by the following timeline:

Zofran History Timeline

  • January 1991: Zofran, known generically as ondansetron. is approved by the U.S. Food & Drug Administration (FDA). The medication is now indicated to treat nausea and vomiting related to chemotherapy and radiation, as well as gastric distress experienced by post-operative surgery patients. During the FDA approval process, GlaxoSmithKline submitted data from four small animal studies which suggested Zofran would not cause birth defects. However, the drug has never been approved to treat pregnancy-related nausea and vomiting.
  • March 1999: GlaxoSmithKline receives a Warning Letter from the FDA for Zofran marketing that the agency said downplayed its potential to cause serious side effects, and overstated its effectiveness.
  • December 2006: The first generic forms of ondansetron become available.
  • September 2011: The Zofran label is updated to include warnings regarding its potential to cause certain heart rhythm problems.
  • January 2012: A study published by the U.S. Centers for Disease Control’s Nation Center on Birth Defects and Developmental Disabilities suggests that the use of Zofran in the first trimester of pregnancy doubles the risk for cleft lip and cleft palate.
  • June 2012: GlaxoSmithKline agrees to pay $3 billion to settle federal allegations of improper drug marketing. Among other things, the U.S. Department of Justice accused the company of marketing Zofran for morning sickness, which constitutes an off-label use of the drug.
  • August 2013: Two papers that analyzed pregnancy data from the same Danish health registry report conflicting findings on Zofran and birth defects. The first is reassuring, and finds no fetal risk. But the second, which included more pregnancies and covered a longer period of time, reports that Zofran was related to a 30% increase in birth defects overall, and doubled the risk for heart defects.
  • August 2014: A Swedish study published in Reproductive Toxicity finds that pregnant women who took Zofran during the first trimester of pregnancy were more likely to give birth to a child with cardiac malformations, including septal defects.
  • February 2012: The first two Zofran heart defect lawsuits are filed in U.S. courts, both of which accuse GlaxoSmithKline of concealing data linking the drug to congenital abnormalities. The lawsuits also claim that the company improperly marketed Zofran for the off-label treatment of pregnancy-related nausea and vomiting.

Afraid Your Baby Suffers from a Zofran Birth Defect? Contact Our Attorneys Today.

It is expected that Zofran lawsuits involving serious birth defects will continue to mount in U.S. courts. If you think your baby was harmed because of this medication, please call our attorneys today to learn more about your legal options. Free case evaluations can be arranged by calling (888) 881-3077.

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