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Syrup of Ipecac OTC or not OTC?. Milton Tenenbein, MD Nonprescription Drug Advisory Committee Bethesda MD; June 12, 2003. Syrup of Ipecac OTC or not OTC?. That is the question. Objectives. to discuss the need for OTC status of syrup of ipecac

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syrup of ipecac otc or not otc

Syrup of IpecacOTC or not OTC?

Milton Tenenbein, MD

Nonprescription Drug Advisory Committee

Bethesda MD; June 12, 2003

syrup of ipecac otc or not otc2

Syrup of IpecacOTC or not OTC?

That is the question.

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

disease burden
Disease Burden
  • poison centers reported 1.2x106 exposures in children < 6 in 2001
  • poisoning death is unusual in children < 6
    • 500 per annum in the 1940s
    • 25 in 1997
  • poison prevention is a success story
reasons for success i
Reasons for Success I
  • child resistant closures
  • constituent reformulations
  • anticipatory guidance
  • public education
  • legislation
reasons for success ii
Reasons for Success II
  • poison control centers
  • product formulation/poison treatment databases
  • sophisticated medical treatment resources
  • new antidotes
  • safer medications
two most important reasons
Two Most Important Reasons

1. Child resistant closures

2. Safer medications

poison treatment

Poison Treatment

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

traditional hospital management
Traditional Hospital Management

Gastric Emptying

  • syrup of ipecac, or
  • gastric lavage

Toxin Adsorption

  • activated charcoal + a cathartic
poison treatment in the home
Poison Treatment in the Home
  • ipecac became an “obvious” intervention
  • FDA OTC status since 1965
  • a policy of the AAP (Pediatrics 1994;94:566-7)
    • TIPP
    • other injury prevention publications
    • poison prevention brochures
  • a policy of the AAPCC
support for ipecac in the home
Support for Ipecac in the Home
  • AAP & AAPCC are reviewing this policy
  • its rescinding is anticipated
aact eapcct position papers j toxicol clin toxicol 1997 35 695 762
AACT/EAPCCT Position PapersJ ToxicolClin Toxicol 1997;35:695-762
  • 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
aact eapcct position paper j toxicol clin toxicol 1997 35 699 799
AACT/EAPCCT Position PaperJ ToxicolClin Toxicol 1997;35:699-799
  • 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
ipecac in the home a health hazard
“Ipecac in the HomeA Health Hazard?”

Clin Toxicol 1981;18:969-972

“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.”

ipecac efficacy
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.

ipecac performance
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
ipecac adverse effects
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
ipecac inappropriate use
Ipecac - Inappropriate Use
  • frequently used when not indicated
  • occasionally used when contraindicated
ipecac misuse
Ipecac - Misuse
  • eating disorders
  • Munchausen Syndrome by Proxy
aapcc data ipecac use
AAPCC Data% Ipecac Use

1985: 15%

2001: 0.7%

decreased hospital visits
Decreased Hospital Visits
  • an assumed benefit of ipecac in the home

 decreased hospital visits

decreased hospital visits23
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.

alternative

Alternative

Charcoal in the Home

charcoal in the home
Charcoal in the Home

Shortcomings

  • poorly accepted by young children
    • in E.D. - frequently given by nasogastric tube
  • sedimentation during storage
  • messy - caretaker acceptance?
charcoal in the home published experience
Charcoal in the HomePublished Experience
  • 3 articles and 3 abstracts
  • therapeutic dose not given >50%
  • home vs E.D. administration
    • 35 vs 65 minutes
  • potential benefit of this 30 minutes?
charcoal in the home27
Charcoal in the Home

Clin Pediatr Emerg Med 2000;1:191-194

  • premature to recommend this intervention
conclusions
Conclusions
  • discontinue use of ipecac in the home
  • premature to use charcoal in the home
question 1
Question 1

Role of gut decontamination?

  • limited
  • serious poisonings presenting to the hospital within one hour
question 2
Question 2

Role of ipecac in gut decontamination?

  • no role
question 2a
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
question 2b
Question 2b

Literature assessment of benefits/risk?

  • no literature demonstrating benefit
  • literature describing risks
    • adverse effects - quantified
    • misuse - anecdotal
    • abuse - anecdotal
    • complications - anecdotal
question 2c
Question 2c

Remote populations?

  • no evidence for efficacy of ipecac
  • efficacy does not improve with distance from care
question 3
Question 3

Abuse potential of syrup of ipecac?

  • Eating Disorders
    • occasional
  • Munchausen Syndrome by Proxy
    • rare
question 4
Question 4

What are alternatives to ipecac?

  • Hospital - activated charcoal
  • Home - call the Poison Centre
summary and conclusion
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.