Zoll & Kranz, LLC is stepping up its investigation into congenital birth defects, including heart defects, cleft palate, and cleft lip injuries caused by Zofran. Zofran, also known generically as Ondansetron, was developed by GlaxoSmithKline (GSK) to treat nausea caused by chemotherapy.
However GSK promoted Zofran off label for morning sickness. Recent studies have shown that Zofran crosses the placental barrier, and if taken during the first trimester can cause heart defects and cleft palate. It is a serotonin 5-HT3 receptor antagonist .
Researchers Anderka M, Mitchell AA, Louik C, et al. studied medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94: 22–30. That large control study by the Sloan epidemiology unit and the Centers of Disease Control and Prevention detected a 2-fold increased risk for cleft palate associated with ondansetron taken in the first trimester of pregnancy [odds ratio = 2.37 (95% CI, 1.28–4.76)].
According to the United States Department of Justice, “GSK agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.” The U.S. Department of Justice further stated that the charges included claims for promoting “Zofran for off-label, non-covered uses” and was “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”
The FDA has issued Drug Safety Communications (link to the 2012 Drug Safety Communication), for use in pregnancy, but this comes too late for many kids. If you took Zofran during your first trimester of pregnancy and your child was born with a cleft palate, cleft lip, heart defect, or similar problem, we would like to talk to you and order copies of your prescription records. Call toll free 1-888-841-9623. There is no cost and no fee unless we obtain a recovery.
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