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Ipecac Syrup

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. INTRODUCTION. Purpose of meeting Outline Agenda Speakers

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Ipecac Syrup

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  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

  2. 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

  5. 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

  6. Discussion Points • Discuss the role of Gastrointestinal Decontamination (GID) in poison management

  7. 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 risk:benefit ratio of ipecac syrup for OTC use?

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

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