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Four Studies Link Zofran and Birth Defect Risk


June 5, 2015 — Seven families have filed lawsuit alleging that Zofran causes birth defects, and now at least four studies have found evidence supporting this link.

Zofran, the brand-name of ondansetron, is an anti-nausea medication made by GlaxoSmithKline (GSK). The FDA approved it in 1991 for chemotherapy and surgery patients with severe nausea and vomiting.

For the last 30 years, there was no FDA-approved drug for pregnant women with severe morning sickness in the first trimester and Zofran became a popular “off-label” (unapproved) treatment.

In recent years, four studies have found evidence that Zofran is not safe to use during pregnancy due to the risk of cleft palate, heart defects, and other major birth defects:

  • One study published last year in Reproductive Toxicology found a doubled risk of “hole in the heart” (septal heart defects) in babies exposed to Zofran.
  • In 2013, BioMed Research International published a study linking the use of Zofran with a 20% increased risk of birth defects and higher rates of premature birth.
  • Zofran was linked to a 2.4-fold increased risk of cleft palate in a study published by researchers from Harvard University and the Centers for Disease Control (CDC).
  • The use of Zofran was linked to a 30% increased risk of birth defects in a study involving 900,000 pregnancies in Denmark from 1997-2010. Birth defects occurred in about 4.7% of babies exposed to Zofran in the first trimester.

In 2012, GSK agreed to pay a $3 billion settlement for illegally promoting Zofran as a safe treatment for pregnant women. Lawsuits have already been filed by seven families who had a baby with a birth defect and accuse GSK of negligence for failing to warn pregnant women about the risks.

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