Comments on Adverse Event Review: Fentanyl Transdermal System

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Comments on Adverse Event ReviewFentanyl
Transdermal System
D. Elizabeth McNeil, MDMedical Officer Division
of Anesthetics, Critical Care and Addiction Drug
ProductsCenter for Drug Evaluation and Research
Food and Drug Administration
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Comments from DACCADP

• Methods of managing the risk due to off-label
  prescribing
• Labeling changes
• Prescriber education through the company
• Dear Health Care Professional letter
• Prescriber education through physician groups

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Question

• The risk management strategy you have heard today
  is very preliminary. Do you have any suggestions
  or additional thoughts that you would like to
  discuss?