Zofran FDA Information and Approval

Stern Law’s experienced drug product attorneys are currently litigating cases involving Zofran. If you took prescription Zofran while pregnant, and your child was born with a congenital defect, contact us today to see if you might be eligible to file a claim against the manufacturer.

Zofran (ondansetron) is a 5-HT3 receptor antagonist. It is a powerful anti-nausea medication manufactured by GlaxoSmithKline (GSK) that was approved in 1991 for distribution. The U.S. Food and Drug Administration (FDA) approved Zofran for the narrowly tailored use of preventing and treating nausea and vomiting associated with radiation and chemotherapy treatment in patients with cancer.

In the early 2000s, however, Zofran became a widely prescribed remedy for nausea and vomiting in pregnant women, commonly known as morning sickness. Morning sickness is not an approved use for the drug, and pregnant women using Zofran are at risk for birth defects, including:

  • Club foot
  • Cleft palate
  • Cleft lip
  • Heart defects
  • Skull deformities

Stern Law and firms across the country have filed hundreds of lawsuits alleging GSK never sought approval for Zofran as treatment for morning sickness but knew about and facilitated this off-label use among healthcare providers. While doing so, it failed to conduct appropriate testing or issue warnings about the potential link between Zofran and serious birth defects.

While Zofran is still on the market for its originally approved uses, the FDA has issued several warnings regarding the drug. In 2011, 2012, and 2014, the FDA published communication to patients and healthcare providers warning that Zofran could cause abnormal heart rhythm and serotonin syndrome, both of which are potentially fatal.

The FDA has not yet taken a position on Zofran use during pregnancy or its association with birth defects, but it has also not approved use of Zofran for morning sickness or for any treatment in pregnant women. Investigation is ongoing, and Zofran cases have been consolidated into a Multidistrict Litigation in the District of Massachusetts federal court.

Contact Stern Law, PLLC

At Stern Law, we recognize that an injury to your child is extremely traumatic, and we are committed to helping you and your family through this difficult time. If you took Zofran while pregnant, and your child has a birth defect, contact Stern Law, PLLC, at (844) 808-7529, to schedule a free consultation with one of our compassionate product liability attorneys.

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