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Zofran

Zofran Poses Significant Risk to Fetuses

In 1991, the U.S. Food and Drug Administration (FDA) approved Zofran (ondansetron) as a treatment for nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. However, with Zofran’s patent expiration date looming, GlaxoSmithKline (GSK) began marketing Zofran “off-label” as a treatment for pregnancy-related nausea.

The FDA has not approved Zofran as a treatment for morning sickness, and recent studies indicate Zofran can hamper fetal development, resulting in miscarriage, intrauterine growth restriction, congenital heart defects, and oral clefts.

ZOFRAN SIGNIFICANTLY RAISES RISK OF BIRTH DEFECTS

  • In 2013, an analysis of 900,000 pregnancies showed that mothers who took Zofran during their pregnancies were 30% more likely to have a baby with a birth defect than mothers who did not take Zofran during their pregnancy.
  • The same study showed that taking Zofran while pregnant more than double a child’s risk of being born with heart defects and abnormalities.
  • That same year, an Australian study concluded that use of Zofran during the first trimester was associated with a 20% increased risk of birth defects. Researchers also noted a 6-fold increase in the risk of renal, pelvis, and ureter defects.
  • Another study published in 2012 suggests treatment with Zofran during pregnancy is associated with a two-fold increased risk of cleft palate.

GSK ORDERED TO PAY $3 BILLION TO SETTLE “OFF-LABEL” MARKETING

In 2012, the United States Department of Justice announced that GlaxoSmithKline would pay $3 billion in order to settle a whistleblower lawsuit regarding the illegal promotion of multiple drugs, including Zofran.

Despite the lawsuit, physicians continue to prescribe Zofran to pregnant women with significant morning sickness. It is estimated that over a million pregnant women are treated with Zofran every year.

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