425 LAWSUITS ALLEGING ZOFRAN CAUSES BIRTH DEFECTS

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Researcher: Ariana Arce​

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Journalist: Aaron Vivanco

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Editor: Daniela Polo

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425 LAWSUITS ALLEGING ZOFRAN CAUSES BIRTH DEFECTS

Zofran® (generically known as ondansetron) is used to treat nausea and vomiting that may be caused by surgery, chemotherapy, or radiation therapy. Healthcare professionals also prescribe ondansetron during pregnancy to reduce symptoms of nausea and vomiting.

Studies on Zofran:

  1. Some studies have noted an association between Zofran use in the first trimester of pregnancy and birth defects such as congenital cardiac (heart) malformations. According to a 2012 Star analysis, at least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations.
  2. However, another study from the Slone Epidemiology Center at Boston University, in collaboration with the Centers for Disease Control and Prevention, found that taking ondansetron during early pregnancy did not appear to increase the chance of birth defects in babies.

Lawsuit update:

These 425 lawsuits were filed because the manufacturer of Zofran, GlaxoSmithKline (GSK), did not warn women that this drug could lead to birth defects if the drug was taken during pregnancy.
However, in 2022, Judge F. Dennis Saylor ruled that the Food and Drug Administration (FDA) would not have allowed a pregnancy warning on Zofran’s label, citing the FDA’s recent rejection of a request to add a warning. This ruling dismissed 425 Zofran lawsuits in the MDL class action. Thus, it is possible that these claims will be unsuccessful upon appeal.

FDA rejected warning on Zofran’s label:

• Chief U.S. District Judge F. Dennis Saylor in Boston said there was “no doubt” that the FDA would not have allowed GSK to include such a pregnancy warning on Zofran’s label after the FDA recently rejected a request to add one.
Moreover, Saylor found the FDA had now been “fully informed of the justifications for the warning proposed by plaintiffs,” including the animal studies.


• Novartis AG acquired the drug in 2015. In June 2020, Novartis proposed changing Zofran’s label to warn about those risks, based on recently published studies. However, the FDA, which had earlier rejected similar proposals to change the label, rejected Novartis’ proposed warning in early 2021 after concluding that the available data did not support a recommendation to avoid Zofran during pregnancy.

GlaxoSmithKline withheld vital information:

In February 2019, Judge F. Denna agreed with the plaintiffs that claims should proceed to trial. The plaintiffs alleged that GSK withheld vital information that indicated an association between Zofran and birth defects in animals. Therefore, in 2012, GSK was fined $3 billion to settle charges from the federal government for fraud and failure to report safety data. Further, GSK was charged with promoting many of its best-selling drugs, including Zofran, off-label.
Both the FDA and GSK withheld vital information, hundreds of birth defects have occurred, and neither has been held accountable.