GSK Illegally Promoted Zofran Off-Label For Treating Pregnancy Nausea, Suit Says

GlaxoSmithKline LLC illegally promoted Zofran off-label as a treatment for pregnancy-related nausea and failed to warn the drug could cause serious birth defects, according to a complaint by the parents of a girl who died of a heart defect several days after birth (Regan v. GlaxoSmithKline, LLC, N.D. Ohio, 15-01166, filed 6/10/15).

GSK failed to properly label Zofran (ondansetron), marketed the drug beyond its Food and Drug Administration—approved uses and didn’t caution the family and their physicians about Zofran’s risks, despite knowledge the medication was dangerous to pregnant women, the plaintiffs allege in the June 10 complaint ...