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Zofran (ondansetron) was approved by the U.S. Food and Drug Administration (FDA) more than 15 years ago for the purpose of preventing the nausea and vomiting that can occur following chemotherapy or radiation treatment for cancer, and surgery. Zuplenz, manufactured by Galena Biopharma Inc., was approved by the FDA in 2010 for similar indications.
During the past decade, physicians have used Zofran and Zuplenz “off-label” to treat women suffering from severe nausea and vomiting during pregnancy. The FDA has not approved Zofran or Zuplenz for this use.
Zofran and Pregnancy
Typically, before a pharmaceutical company can market a new medication to consumers, the company must test the drug thoroughly. The company must apply for FDA approval for each separate use, known as an “indication,” of the drug.
In addition, while doctors can use medicines for any purpose they think necessary, drug manufacturers are not allowed to advertise their medications for uses that have not been approved by the FDA. This is called “off-label” promotion, and companies who do this may pay heavy penalties for this practice, known as “misbranding.”
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In fact, the manufacturer for Zofran, GlaxoSmithKline LLC (GSK), has settled civil claims with the U.S. Department of Justice regarding the unlawful promotion of Zofran and other medications, agreeing to pay $2 billion for this and other civil allegations.
The settlement also addressed claims that GSK had paid kickbacks to health care providers, encouraging them to promote and prescribe drugs for unapproved uses, including the use of Zofran for the treatment of morning sickness in pregnant women.
Zofran and Zuplenz Approved for Cancer-Treatment Nausea; Not Morning Sickness
Neither GSK nor Galena Biopharma has published clinical data examining the effects Zofran and Zuplenz have on pregnant women or their developing children.
Recent studies have examined data that indicate ondansetron may not be entirely safe when used during pregnancy; there may be an increased risk to babies exposed to this drug.
Using Zofran or Zuplenz during the first trimester of pregnancy may lead to birth defects, specifically to an increased risk of having a baby born with a cleft lip or palate. Study results also indicate there may be an increased risk of congenital heart defects, especially ventricular or atrial septal defects.
Repairing these defects may require expensive surgical procedures, such as open heart surgery. Facial and palate repair of clefts can also require extensive surgery and can leave significant scarring. Patients are also likely to have to deal with pain and suffering during the recovery period.
Any mothers who took Zofran or Zuplenz as a treatment for nausea or vomiting during pregnancy unknowingly exposed their unborn children to these risks.
Exposure to Zofran or Zuplenz in utero that may have caused birth defects could have been avoided had healthcare providers and mothers been warned of these potential complications.
If you have had a similar experience as a mother of an injured child, you may be able to receive compensation. We can help you determine if you should pursue the matter legally.
Adults born between 1991-97, whose mothers used this drug during pregnancy, may also want to consider their legal options by contacting our firm.