Joseph Camardo, MD

1
Joint Meeting of the Psychopharmacologic Drug and
Pediatric Advisory Committees

• Joseph Camardo, MD
• Senior Vice President, Global Medical Affairs

September 13, 2004
2
Antidepressant Use in Pediatrics

• Mental illness, including depression, in
  pediatric patients is a tragic and complex
  medical condition.
• Physicians need options to treat individual
  children.
• Venlafaxine has never been indicated for use in
  pediatric patients and Wyeth did not recommend
  such use.
• Wyeth conducted clinical trials in pediatric
  patients with MDD and GAD.
• There were increased reports of hostility and
  suicide related events in venlafaxine pediatric
  clinical studies.
• Wyeth communicated these results in labeling and
  to over 450,000 HCPs via a letter in August 2003.

3
The Limitations of the Current Analysis Precludes
Valid Comparisons Among Drugs

• Examples
• Differences in study populations.
• Differences in trial designs.
• Differences in inclusion/exclusion criteria.
• Differences in ascertainment of adverse events
  and completeness of narratives.
• Differences in rates of early discontinuations.
• Inconsistent assessment of noncompliance.

4
Wyeths Point of View

• Mental Illness, including depression, in
  pediatric patients is a tragic and complex
  medical condition.
• Information about increased risk of suicidality
  with antidepressants in pediatric patients should
  be provided to HCPs.
• The information should be consistent for all
  antidepressants.
• Options to use antidepressants for pediatric
  patients should be maintained.