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Report: Anti-Nausea Drug Zofran Linked to Birth Defects

A Toronto newspaper report has linked the anti-nausea drug ondansetron, better known by its brand name Zofran, to birth defects in pregnant women. The Toronto Star report examined data from a U.S. Food and Drug Administration study examining the effects of Zofran on pregnant women. The study found that at least four Canadian women who took the drug reported that their newborns weighed as little as four pounds, eight ounces. Another six cases reported “fetal growth restriction” among the drug’s side effects.

“Off-Label” Zofran Prescriptions

The major component of the controversy over Zofran is its “off-label” use to treat hyperemesis gravidarum, a form of severe nausea in pregnant women. Doctors typically prescribe Zofran for severe nausea, such as symptoms experienced by chemotherapy patients. The Star report showed that numerous doctors had been prescribing the drug for pregnant women who reported suffering from severe nausea. The women reported taking the drug during the first trimester of pregnancy, during which their symptoms are at their most severe and when the fetus is at its most vulnerable.

List of Birth Defects Linked to Zofran

The newspaper report examined Zofran side-effect data compiled by the FDA from 2010 to 2013. The report included birth defects such as:

  • “Fetal growth restriction”
  • “Musculoskeletal anomaly”
  • “Atrial septal defect” (hole in the heart)
  • Mouth deformities
  • Jaundice
  • Heart murmur
  • Heart defects

The story also quoted a Danish study that examined data from nearly a million births. The study showed that mothers who took Zofran while pregnant reported infant heart defects at twice the rate of infants whose mothers did not take the drug. The researchers have submitted their results to a leading medical journal. The study is pending publication while it undergoes the scientific peer review process.

Could Zofran Be Another Thalidomide?

The report also examines how the controversy over Zofran recalls similar cases from a half-century earlier. In the 1960s, doctors prescribed the tranquilizer thalidomide to mothers with morning sickness, despite the fact that the drug was not intended for that purpose. Years later, mothers who took thalidomide reported severe birth defects and malformations in their infants. Although Zofran has been shown to be effective at treating severe nausea, scientists are examining the parallels between thalidomide and Zofran in treating severe morning sickness.

Source: Toronto Star

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