New Zofran (Ondansetron) Label Draws Ire of Families in MDL

Families involved in the Zofran (ondansetron) multidistrict litigation (“MDL”) alleged a 2016 label update for Zofran acknowledged for the first time that studies have shown an increased link between exposure to Zofran (ondansetron) and cardiovascular and cleft palate birth defects in babies born to women who took the drug while pregnant. However, the families contend that this disclosure came far too late, and that that the label mischaracterized the studies and failed to disclose other studies suggesting Zofran (ondansetron) poses double the risk for these defects when taken during pregnancy.

With more than 200 lawsuits pending in the District of Massachusetts, plaintiffs argue that GSK illegally promoted Zofran (ondansetron) “off-label” for pregnancy-related nausea, a use not approved by the FDA. Plaintiffs’ firm Grant & Eisenhofer filed the first case in the country and over 20 others on behalf of women and families affected by Zofran (ondansetron). Call us today at 877-978-0169 if you or a loved one took Zofran (ondansetron) during your first trimester and your child was born with a congenital heart defect or cleft palate.

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