July 25, 2006
FDA urges drugmakers to add new label info on antidepressant risks
FDA urges drugmakers to add new label info on antidepressant risks New information concerning risks to newborns and migraine sufferers should be added to the labels of selective serotonin reuptake inhibitors (SSRIs) and certain selective serotonin /norepinephrine reuptake inhibitors (SNRIs), the FDA said. The agency warned that taking the antidepressants in combination with triptan migraine medications could result in the life-threatening condition known as serotonin syndrome. The agency also warned about a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. SSRIs include GlaxoSmithKline’s Paxil, Eli Lilly’s Prozac, Pfizer’s Zoloft and Symbyax, Forest’s Celexa and Lexapro and Solvay Pharmaceutical’s Luvox. SNRIs cited by the FDA included Lilly’s Cymbalta and Wyeth’s Effexor.