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Zofran ® Promoted to pregnant women despite never being approved by the FDA for use during pregnancy.


The anti-nausea medication Zofran® (ondansetran) has been prescribed to millions of women and generated hundreds of millions of dollars for the drug manufacturer GlaxoSmithKline. While the drug has received FDA approval for use in treating nausea associated with cancer and general anesthesia, the drug was never determined to be safe or effective for use by mothers during pregnancy. There are significant concerns about the safety of the medication when used during pregnancy.

The Toronto Star reported that physicians have been prescribing the drug for off-label use in alleviating nausea and morning sickness during pregnancy. The FDA adverse event database reveals a number of reports regarding women taking Zofran® during pregnancy giving birth to infants with birth defects. Birth defects that have been associated with the use of Zofran® during pregnancy include:

  • Neural Tube Defects
  • Heart Defects
  • Brain Deformities
  • Gastroschisis
  • Cleft Palate
  • Miscarriage
  • Kidney Defects
  • Cleft Lip
  • Limb Deformities
  • Other Birth Defects/Deformities

The increased risk of fetal heart defects when taken Zofran® during pregnancy was first identified in a study published by the Clinical Pharmacokinetics journal. The study showed evidence that the drug crosses the placenta which raised the risk of fetal birth defects developing in the womb. While heart defects like atrial septal defects, ventricular septal defects and heart murmur can be congenital, they have also been associated with taking Zofran® during the first trimester when the heart is developing.

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Makers of Zofran® Fined $3 Billion for Off-Label Promotion of Drugs.

Fines for Promotion of Non-FDA Approved Uses of Zofran® & Other Drugs

The Justice Department indicated that the manufacturer of Zofran® agreed to plead guilty to three criminal charges which included two counts of introducing misbranded drugs and one count of failing to report safety data to the FDA. The penalty constituted the largest penalty against a pharmaceutical company ever assessed. The company also acquiesced to five years of monitoring by the federal government, so compliance Can be confirmed.


The drug company agreed to settle claims involving civil liability for promoting the drugs, Zofran®,Paxil®, Wellbutrin®, Advair® and Lamictal® for off-label uses that had not been approved by the FDA. The settlement also covered accusations that the pharmaceutical manufacturer paid kickbacks to physicians to prescribe drugs for these off-label uses as well as for prescription of Flovent®, Imitrex®, Valtrex®, and Lotronex®.


While the FDA approved Zofran® for use in relieving nausea associated with chemotherapy, radiation therapy and recuperation from surgery, the drug was never approved by the agency for use during pregnancy. The drug was promoted to physicians for treatment of severe morning sickness and nausea for expectant mothers because this use of the medication vastly expanded the market for the anti-nausea drug. It is estimated that Zofran® was prescribed to more than a million expectant mothers in 2013 alone, which means enormous profits are associated with this off-label use of Zofran®.


Under federal law, drug manufacturers must seek approval for each proposed use of a drug before they can sell the drug to the public for alternate uses. The approval process entails strict protocols to ensure efficacy and safety. The FDA prescribes the protocols for pre-market testing. If drug manufacturers determine that a medication can be used effectively for unapproved purposes, then the drug company must obtain approval for each individual use of the drug. While physicians can prescribe the drug for off-label uses, the drug manufacturer cannot advertise the drug for uses that are not FDA approved.



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