Zofran Resulting in Birth Defects

The information provided on this page is informational only. Thornton Law Firm LLP is no longer accepting Zofran cases.
Zofran_tablet

Women and their doctors were never warned that taking Zofran for nausea during pregnancy could lead to babies being born with severe birth defects including heart defects, cleft palates and lips, club feet, and craniosynostosis. Instead, Zofrans’ manufacturer, GlaxoSmithKline, engaged in deceptive and illegal marketing, promoting Zofran for unapproved (“off-label”) use by pregnant women with morning sickness. GlaxoSmithKline failed to conduct a single study on the safety of using Zofran for pregnant women and never sought FDA approval to market the drug to pregnant women.

Zofran Fast Facts:

  • Zofran (generic name: ondansetron) is an anti-nausea medication.
  • Zofran is approved to treat nausea and vomiting from chemotherapy and radiation, and for post-surgical nausea.
  • The FDA has never approved Zofran for the treatment of morning sickness or any other condition in pregnant women.
  • Zofran was marketed and promoted by GlaxoSmithKline for nausea in pregnant women.
  • GlaxoSmithKline never conducted any studies on the safety of Zofran for pregnant women.
  • GlaxoSmithKline paid a $3 billion dollar fine to the Justice Department in 2012 for illegally marketing Zofran to pregnant women and their doctors.
  • Recent studies show pregnant women prescribed ondansetron (Zofran) suffer a two-fold increased risk of cardiac malformations, leading to a 30% increased risk of major cardiac birth defects.

Who uses it and for what conditions?

Zofran is intended to be used by patients who suffer from nausea and vomiting as a result of undergoing chemotherapy and radiation. It is also prescribed to help control nausea in post-surgical patients. Despite the limited uses Zofran was approved for, GlaxoSmithKline marketed the drug off-label as a remedy for pregnancy-induced morning sickness.

 

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