Zafran Lawsuit
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Zofran, an anti-nausea drug that is used “off-label” for morning sickness in pregnancy, has been linked to hundreds of reports of birth defects. Studies have also found a 30% increased risk of birth defects  overall, a doubled risk of “hole in the heart” defects, and even higher rates of cleft palate.

While Zofran was never tested or approved for use by pregnant women, it is often prescribed off-label for morning sickness and hyperemesis gravidarum, a serious type of morning sickness that causes severe nausea and weight loss. Now, recent studies have shown that expecting mothers who took Zofran are at a higher risk for delivering children with the following birth defects: Heart defects, including septal defects or holes in the heart Craniofacial defects, including cleft palates Kidney malformations

Several recent studies have found that Zofran may be linked to an increased risk of birth defects.

Zofran Birth Defects

  • Heart defects
  • Heart murmur
  • Atrial septal defect
  • Ventricular septal defect
  • Hole in the heart
  • Cleft lip
  • Cleft palate
  • Musculoskeletal Defects
  • Fetal growth restriction (poor growth in the womb)
  • Kidney defects
  • Hydronephrosis
  • Hypospadia
  • And more

Zofran was approved by the US Food & Drug Administration in 1991. Initially, the drug was designed and cleared for the treatment of nausea and vomiting caused by potent cancer treatments like chemotherapy. Its approval would be further extended to cover patients suffering from nausea during rounds of radiation therapy and for patients who experience nausea after going under anesthesia. It was never, and is still not, approved for the treatment of morning sickness. But no sooner had Zofran been released onto the US market than physicians across the country began using it to treat the nausea and vomiting of pregnancy.


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