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Zofran (ondansetron) was approved by the FDA in 1991 for use as an anti-nausea drug by cancer patients. The FDA did not approve Zofran for treatment of morning sickness during pregnancy. Zofran was made by GlaxoSmithKline who promoted Zofran for use by pregnant women to treat nausea. This is known as an “off-label” use.

GSK Was Fined For “Off-Label” Promotion of Zofran

The United States Department of Justice fined GlaxoSmithKline $3 billion dollars in 2012. This fine was levied against GlaxoSmithKline for its off-label promotion of Zofran and other medications.

Birth Defects Associated With Zofran Use

Several medical studies have determined that Zofran causes birth defects:

The studies have found a relationship between Zofran use by pregnant mothers and the following birth defects:

  • Cleft lip
  • Heart gefects
  • Heart valve malfunction
  • Cleft palate
  • Hole in the heart
  • kidney malformation
  • Clubfoot
  • heart murmur
  • cranial facial defects

The attorneys at Bohrer Brady LLC, are evaluating Zofran birth defect cases. For a free, confidential consultation and case evaluation, please contact the Zofran birth defect lawyers at Bohrer Brady LLC.

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