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Psychopharmacologic Drugs Advisory Committee (PDAC) December 13, 2006 Introductory Comments

Psychopharmacologic Drugs Advisory Committee (PDAC) December 13, 2006 Introductory Comments. Thomas Laughren, M.D. Director, Division of Psychiatry Products Food and Drug Administration. Standard Language in Antidepressant Labeling.

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Psychopharmacologic Drugs Advisory Committee (PDAC) December 13, 2006 Introductory Comments

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  1. Psychopharmacologic Drugs Advisory Committee (PDAC)December 13, 2006Introductory Comments Thomas Laughren, M.D. Director, Division of Psychiatry Products Food and Drug Administration

  2. 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.”

  3. 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.”

  4. Earlier Analyses ofAdult Suicidality Data • Beasley, et al, 1991 • Khan, et al, 2000 • Storosum, et al, 2001 • Hammad, et al, 2006

  5. 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

  6. 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

  7. 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

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