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Zofran Lawsuit

Zofran (ondansetron) is the most-prescribed pharmaceutical treatment for morning sickness, an extremely common issue with pregnant women. However, the U.S. Food and Drug Administration never approved the drug for that use.

Newborn children who have suffered birth defects after mothers took Zofran while pregnant have sued the maker of Zofran, GlaxoSmithKline, over allegations that it marketed the drug to pregnant women without FDA approval.

FDA Warning:

FDA has cautioned against the use of Zofran during pregnancy

What is a Zofran?

Zofran® (ondansetron) blocks the actions of chemicals in the body that can trigger nausea and vomiting. Zofran® is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy or radiation). zofran-class-action-lawsuitZofran® is not for preventing nausea or vomiting that is caused by factors other than cancer treatment or surgery.

According to our research, Zofran® was designed to treat patients who had severe nausea typically associated with cancer treatments such as chemotherapy or radiation. But the lawsuit (Flynn v. GlaxoSmithKline 2/12/15) alleges GlaxoSmithKline not only marketed Zofran® “off-label” as a safe and effective treatment for pregnancy-related nausea and vomiting, it did so without even having tested the drug for its potential risks or FDA Approval!

Possible dangers of taking Zofran while pregnant

Pregnant women who were prescribed Zofran® (ondansetron) an anti puking medicine was never approved for consumption by pregnant woman and caused birth defects. Their physicians may not have been told either.

The consequence, in some cases, fell upon some Zofran® users’ unborn children and birth defects. These pharmaceutical manufacturer need to be held responsible for the adverse birth defects Zofran drugs may be responsible for.

Using Zofran® while pregnant may increase the risk of these side effects in babies:

  • Heart defects
  • Heart murmur
  • Atrial septal defect
  • Cleft lip
  • Cleft palate
  • Fetal growth restriction
  • Jaundice
  • Kidney defects
  • Pregnancy complications
  • Other birth defects

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