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Psychopharmacologic Drugs Advisory Committee (PDAC)December 13, 2006Introductory Comments Thomas Laughren, M.D. Director, Division of Psychiatry Products Food and Drug Administration
Standard Language inAntidepressant Labeling • “Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.”
Clinical Psychiatry, by Mayer-Gross, Slater, and Roth, London, 1960, p. 231 • “With beginning convalescence (following initiation of treatment with tricyclic antidepressants), the risk of suicide once more becomes serious as retardation fades.”
Earlier Analyses ofAdult Suicidality Data • Beasley, et al, 1991 • Khan, et al, 2000 • Storosum, et al, 2001 • Hammad, et al, 2006
FDA Regulatory Actions Based on Pediatric Suicidality Data • New warning language (including box) and medguide • Notes increased risk of suicidality in short-term pbo-controlled antidepressant trials (4% vs 2%) • Notes no completed suicides • Advice: balance risk with clinical need • Prescribers should observe for worsening, suicidality, or unusual changes • Families should also observe for change and communicate with prescriber
BMJ Papers on Adult SuicidalityFebruary 17, 2005 • Fergusson, et al, 2005 • Systematic review; published reports of pbo-controlled trials for antidepressants • Gunnell, et al, 2005 • Systematic review; summary data for pbo-controlled trials for SSRIs, from MHRA website • Martinez, et al, 2005 • Nested case control study; GPRD
Goals of Today’s Meeting • FDA will present findings from meta-analysis of adult suicidality data • FDA will provide interpretation of these data • FDA will briefly outline plans for labeling modifications based on new findings • We request discussion and general comments on findings and FDA plans