Antidepressant Relabeling Will Include Pediatric Efficacy Data
Executive Summary
FDA's plan for relabeling antidepressants to address pediatric safety concerns will involve some negotiation with sponsors over how best to present efficacy data
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Antidepressant MedGuide
FDA's patient Medication Guide on antidepressants and pediatric suicidality will be available by the end of January, agency says. FDA releases 1proposed MedGuide Nov. 3 with language subject to negotiations with antidepressant drug sponsors; the agency hopes to finalize it by December. The MedGuide is one piece of FDA's plan to alert patients and prescribers to the antidepressant pediatric suicidality risk, which also includes a "black box" warning and unit-of-use packaging (2"The Pink Sheet" Oct. 26, 2004, p. 6). The proposed language generally follows FDA's antidepressant labeling changes, but does point to a potential relationship between antidepressants and violent behavior...