Syrup of Ipecac OTC or not OTC?

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Syrup of IpecacOTC or not OTC?

• Milton Tenenbein, MD
• Nonprescription Drug Advisory Committee
• Bethesda MD June 12, 2003

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Syrup of IpecacOTC or not OTC?

• That is the question.

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Objectives

• to discuss the need for OTC status of syrup of
  ipecac
• to discuss four specific questions posed by the
  committee

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Committee Questions

• 1. Role of gut decontamination?
• 2. Role of ipecac in gut decontamination?
• 2a. Benefits and risks of ipecac?
• 2b. Literature assessment of benefits/risk?
• 2c. Remote populations?
• 3. Abuse potential of syrup of ipecac?
• 4. What are alternatives to ipecac?

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Disease Burden

• poison centers reported 1.2x106 exposures in
  children lt 6 in 2001
• poisoning death is unusual in children lt 6
• 500 per annum in the 1940s
• 25 in 1997
• poison prevention is a success story

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Reasons for Success I

• child resistant closures
• constituent reformulations
• anticipatory guidance
• public education
• legislation

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Reasons for Success II

• poison control centers
• product formulation/poison treatment databases
• sophisticated medical treatment resources
• new antidotes
• safer medications

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Two Most Important Reasons

• 1. Child resistant closures
• 2. Safer medications

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Poison Treatment

• Gastrointestinal decontamination is cardinal
  principle in the management of the overdose
  patient.

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Traditional Hospital Management

• Gastric Emptying
• syrup of ipecac, or
• gastric lavage
• Toxin Adsorption
• activated charcoal a cathartic

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Poison Treatment in the Home

• ipecac became an obvious intervention
• FDA OTC status since 1965
• a policy of the AAP (Pediatrics 199494566-7)
• TIPP
• other injury prevention publications
• poison prevention brochures
• a policy of the AAPCC

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Support for Ipecac in the Home

• AAP AAPCC are reviewing this policy
• its rescinding is anticipated

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AACT/EAPCCT Position PapersJ Toxicol Clin
Toxicol 199735695-762

• 5 position papers - hospital treatment
• ipecac gastric lavage charcoal cathartics
  whole bowel irrigation
• retired ipecac, lavage and cathartics
• advocates charcoal as first line therapy
• emphasis upon first hour after ingestion

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AACT/EAPCCT Position PaperJ Toxicol Clin Toxicol
199735699-799

• specific ipecac statement
• its routine administration in the emergency
  department should be abandoned
• no definitive statement on ipecac in the home
• this statement generated considerable thought,
  discussion and debate regarding ipecac in the home

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Ipecac in the HomeA Health Hazard?

• Clin Toxicol 198118969-972
• The ipecac story is but another example of a
  seemingly sensible preventive health strategy
  being universally recommended and widely accepted
  before its efficacy and validity has been
  established.

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Ipecac - Efficacy

• There are no data that support benefit for the
  patient from ipecac in the home.
• There are data that support lack of benefit for
  the patient treated with ipecac in the hospital.

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Ipecac - Performance

• Children
• 28 of dose removed (range 0-78)
• (immediately after ingestion)
• thus - poor and unreliable performance
• Adults
• 5 min 51-83 removal
• 30 min 2-59 removal

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Ipecac - Adverse Effects

• emesis is unpleasant
• persistent vomiting 13-17
• diarrhea 8-13
• lethargy 12-21
• inability to tolerate subsequent therapies
• activated charcoal
• N-acetylcysteine
• whole bowel irrigation

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Ipecac - Inappropriate Use

• frequently used when not indicated
• occasionally used when contraindicated

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Ipecac - Misuse

• eating disorders
• Munchausen Syndrome by Proxy

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AAPCC Data Ipecac Use
1985 15 2001 0.7
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Decreased Hospital Visits

• an assumed benefit of ipecac in the home
• ? decreased hospital visits

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Decreased Hospital Visits

• Home use of ipecac was very weakly associated
  with increased, not decreased referral to the
  ED.
• Bond GR. Home syrup of ipecac use after
  pediatric pharmaceutical exposure does not reduce
  emergency department use or improve outcome.
  Pediatrics, in press.

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Alternative

• Charcoal in the Home

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Charcoal in the Home

• Shortcomings
• poorly accepted by young children
• in E.D. - frequently given by nasogastric tube
• sedimentation during storage
• messy - caretaker acceptance?

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Charcoal in the HomePublished Experience

• 3 articles and 3 abstracts
• therapeutic dose not given gt50
• home vs E.D. administration
• 35 vs 65 minutes
• potential benefit of this 30 minutes?

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Charcoal in the Home

• Clin Pediatr Emerg Med 20001191-194
• premature to recommend this intervention

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Conclusions

• discontinue use of ipecac in the home
• premature to use charcoal in the home

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FDA NDAC Questions
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Question 1

• Role of gut decontamination?
• limited
• serious poisonings presenting to the hospital
  within one hour

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Question 2

• Role of ipecac in gut decontamination?
• no role

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Question 2a

• Benefits and risks of ipecac?
• speculated benefit - removal of poison
• risks -
• persistent vomiting 13-17
• diarrhea 8-13
• lethargy 12-21
• poor tolerance of subsequent oral therapies
• inappropriate use and frank misuse

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Question 2b

• Literature assessment of benefits/risk?
• no literature demonstrating benefit
• literature describing risks
• adverse effects - quantified
• misuse - anecdotal
• abuse - anecdotal
• complications - anecdotal

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Question 2c

• Remote populations?
• no evidence for efficacy of ipecac
• efficacy does not improve with distance from care

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Question 3

• Abuse potential of syrup of ipecac?
• Eating Disorders
• occasional
• Munchausen Syndrome by Proxy
• rare

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Question 4

• What are alternatives to ipecac?
• Hospital - activated charcoal
• Home - call the Poison Centre

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Summary and Conclusion

• Since the use of ipecac in the home will no
  longer be recommended and since there is a
  potential for its misuse and abuse, it makes no
  sense for it to remain as an OTC drug.