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  • Drug Safety Alert- Zofran

    Galfand Berger is investigating potential lawsuits involving birth defects associated with the use of the prescription medication Zofran.

    Babies born to women who used Zofran to treat nausea and vomiting during pregnancy are at increased risk for developing birth defects.  Potential birth defects caused by Zofran include:

    • Cleft lip
    • Cleft palate
    • Heart malformations
    • Club feet
    • Craniosynostosis –abnormally shaped skull

    Zofran, made by GlaxoSmithKline, and its generic form, odanestron, have been widely prescribed to pregnant women to treat nausea and vomiting in pregnancy; however, Zofran is not labeled for use during pregnancy, not indicated to treat nausea and vomiting associated with pregnancy, and not classified as safe for use during pregnancy by the Food and Drug Administration.

    Zofran was approved by the FDA in 1992 to treat nausea and vomiting in cancer patients and post-surgical patients.

    Research studies indicate that using Zofran during the first trimester can increase the overall risk of birth defects by 30%.  The risk of cardiac defects is increased 2-fold with the use of Zofran.

    Safer medications are available to treat morning sickness in pregnancy.  A combination of doxylamine and pyridoxine has been approved by the FDA as a safe and effective medication to treat nausea and vomiting in pregnancy, yet many doctors continue to prescribe Zofran to pregnant patients despite the risks.

    GlaxoSmithKline pled guilty to federal charges for illegally marketing Zofran as a treatment option for pregnancy-related morning sickness.

    If you were prescribed Zofran or odanestron during pregnancy and your child was born with a birth defect, call Galfand Berger at 1-800-222-8792 or contact us online.  Our Philadelphia personal injury law firm represents clients who have suffered as a result of medical malpractice and defective products.