A new study out of the Journal of the American Medical Association has shed some light on a longtime concern of the FDA that taking prescription drugs for uses unapproved by the regulatory agency may do more harm than good. In fact, researchers from McGill University in Montreal, Harvard Medical School, and MCPHS University who led the study concluded that using prescription drugs for off-label uses as compared to on-label contributed to a 44% increased risk of suffering an adverse event. Over a 5-year period, researchers monitored off-label drug use among some 46,000 Canadian patients who were given over 151,000 prescriptions—some of them written for unapproved uses. After following up with patients at the end of their treatments, nearly 3,500 adverse events were reported. Furthermore, risks for such events were found to be higher in drugs used by women and for drugs approved from 1981 to 1995—drugs that include anti-nausea medication Zofran (ondansetron), first approved by the FDA in 1991 for use in cancer patients undergoing chemotherapy.
Over the years, pharmaceutical companies have engaged in this illegal “off-label” drug marketing, and more often than not, to a fault: GlaxoSmithKline (“GSK”) was charged with promoting several of its blockbuster drugs off-label in 2012, including Zofran (ondansetron), which led to a settlement with the federal government of $3 billion. GSK has come under fire yet again in the newly-formed Zofran (ondansetron) multi-district litigation centralized in Massachusetts under Judge F. Dennis Saylor, IV, with dozens of plaintiffs alleging that the anti-nausea drug caused cleft palate and congenital heart defects in children born to mothers who took Zofran (ondansetron) during the pregnancies off-label, unknowingly, to alleviate morning sickness.
Attorneys at Grant & Eisenhofer are investigating several instances of alleged off-label marketing by pharmaceutical companies, and have filed cases on behalf of plaintiffs claiming they were affected by adverse events due to wrongful drug promotion. Particularly, G&E is one of the leading firms in the Zofran (ondansetron) MDL, and has filed some of the first cases against GSK. If you or a loved one took Zofran (ondansetron) during your first trimester to treat nausea and vomiting and your child was born with a cleft palate or congenital heart defect, call us today at 877-978-0169 so we may discuss your potential claim with you.