FDA considers expanding indication for Cymbalta; side effects SJS, TEN
A Food and Drug Administration (FDA) advisory committee has narrowly voted to recommend that the indication for Eli Lilly’s antidepressant Cymbalta (duloxetine) be expanded to include use as a treatment for chronic musculoskeletal pain. The Anesthetic and Life Support Drugs Advisory Committee also voted that the benefits were minimal but outweighed the risks, which includes a black box warning of suicidality in children, adolescents and young adults; a potential for liver damage; and a risk of developing the rare skin disease Stevens Johnson Syndrome (SJS) and its more serious form, toxic epidermal necrolysis (TEN).