Ipecac Syrup

1
Ipecac Syrup

• Division of Over-The-Counter Drug Products
• Nonprescription Drugs Advisory Committee Meeting
• Curtis J. Rosebraugh, MD, MPH
• Deputy Director, Division of OTC

Center for Drug Evaluation and Research
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INTRODUCTION

• Purpose of meeting
• Outline Agenda
• Speakers
• Discussion Points

3
Background

• Ipecac Syrup available as OTC since 1965
• OTC availability controversial
• only used under medical supervision
• poison emergency-easy and quick access
• recommended OTC by medical societies
• labeling instructs user to contact health
  provider prior to use
• A vital component in strategies for preventing
  childhood poisoning deaths

4
Background

• Medical societies advocate re-evaluation
• Use of gastric emptying declining
• Insufficient evidence of benefit of therapy
• Possibility of Morbidity/Mortality--Abuse/Misuse

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Presentations

• OTC status of ipecac syrup
• Regulatory history
• Arlene Solbeck, MS
• Use in treatment of poisoning
• Milton Tenenbein, MD
• Anthony S. Manoguerra, Pharm.D.
• William Robertson, MD
• Abuse/Misuse
• Tomas J. Silber, MD

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Discussion Points

• Discuss the role of Gastrointestinal
  Decontamination (GID) in poison management

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Discussion Points

• Is the availability of emergency medical
  treatment (rural vs. urban setting) clinically
  relevant to whether ipecac syrup is used for GID
  in poison management?

8
Discussion Points

• Is the evidence available in the literature of
  adequate quality and quantity to establish the
  riskbenefit ratio of ipecac syrup for OTC use?

9
Discussion Points

• Should ipecac syrup retain OTC status for use by
  consumers to treat accidental poisoning?