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

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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

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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.

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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.

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Earlier Analyses ofAdult Suicidality Data

• Beasley, et al, 1991
• Khan, et al, 2000
• Storosum, et al, 2001
• Hammad, et al, 2006

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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

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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

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Goals of Todays 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