Will a Zofran Recall Be Issued Due to the Birth Defect Risk?



In recent years, concerns have emerged about the potential birth defect risk from Zofran use by pregnant women, leading to questions about whether a recall will be issued to ensure the anti-nausea drug is not used during pregnancy. However, there is no indication that the FDA is considering a Zofran recall.

Zofran (ondansetron) is not even approved for pregnancy-related nausea, more commonly known as morning sickness. The medication is currently only indicated for use to treat nausea and vomiting associated with cancer treatments or surgery.

While new Zofran warnings about the pregnancy risks may be required, it is not likely that a recall for Zofran would be issued given the large number of other, safe uses.

Zofran Recalled in 2012

Unrelated to the potential birth defect risk, a limited Zofran recall was issued in 2012.

The FDA recalled Zofran 32 mg, single intravenous (IV) dose, due to the risk of QT prolongation, which can cause serious and potentially life-threatening heart rhythm problems, including torsades de pointes. However, the FDA did not remove Zofran from the market entirely, limiting the recall to the 32 mg IV dose and requiring stronger warnings about the potential Zofran heart risks.

While a number of studies have suggested a potential link between side effects of Zofran and birth defects for unborn children, this risk can be adequately addressed with stronger warnings for doctors and women to avoid use of Zofran while pregnant.

Lawsuits Over Zofran Birth Defect Risk

The lawyers at Saiontz & Kirk, P.A. represent families throughout the United States who are now pursuing a Zofran lawsuit on behalf of a child diagnosed with a birth defect, such as:

  • Heart Defects
  • Cleft Palate
  • Cleft Lip
  • Other Congenital Birth Defects

According to allegation raised in complaints filed in state and federal courts throughout the U.S., GlaxoSmithKline has failed to provide proper warnings that could have allowed pregnant mothers to make an informed decision to use another drug to treat severe cases of morning sickness.

As a result of the drug makers’ decision to place their desire for profits before consumer safety, even going as far as to market the drug illegally to pregnant women in the face of evidence that the drug caused birth defects, Zofran settlement offers may eventually be available.

All cases are reviewed by our attorneys under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm and we receive no attorney fees or expense reimbursements unless we are successful in obtaining a recovery in your Zofran lawsuit.

Austin Kirk

Last Updated November 16, 2016
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