Clinical Summary

**Background**

The medical literature and some poison control and clinical toxicology
societies have indicated that the safety and efficacy of ipecac syrup
for the use as an over-the-counter emetic in the management of poisoning
should be re-evaluated. The Division of Over-the-Counter Drug Products
has invited experts to provide a detailed analysis of available clinical
data. This Advisory Committee meeting is being convened to address
whether ipecac syrup should remain available as an OTC drug product.

In 1965, the Commissioner of Food and Drugs issued a regulation that
ipecac syrup should be available for sale without a prescription. CFR
201.308 states that it was the \"unanimous recommendation of the
American Academy of Pediatrics, the American Association of Poison
Control Centers, the American Medical Association, and the Medical
Advisory Board of the Food and Drug Administration that ipecac syrup ...
be permitted to be sold without prescription so that it will be readily
available in the household for emergency treatment of poisonings, under
medical supervision... In view of \[these\] recommendations, the
Commissioner of Food and Drugs has determined that it is in the interest
of the public health for ipecac syrup to be available for sale without
prescription...\". Ipecac syrup is listed as an active ingredient in the
Poison Treatment Tentative Final Monograph (TFM) issued January 15,
1985. Its proposed indication is \"For emergency use to cause vomiting
in poisoning.\"

Ipecac contains two active alkaloids, cephaline and emetine. Both act
locally on gastric mucosal receptors and cephaline also acts at the
chemoreceptor trigger zone in the brainstem. The time from ipecac syrup
administration to the onset of vomiting is usually 15 to 30 minutes
following a single dose and usually within 15 minutes following a second
dose, with the duration of vomiting lasting usually one to two hours.
Vomiting occurs in 82% of children after one dose, 99% after two.^1,2^

Other agents used for gastric decontamination include activated charcoal
(adsorbent), magnesium citrate, polyethylene glycol, and sorbitol
(cathartics).

**Ipecac Efficacy**

In animal studies, ipecac syrup induced emesis removes 10% to 60% of an
ingested substance. In clinical studies, a mean of 30% of a toxin can be
recovered from an individual, but the amount is variable (range of
28%-83%).^1,3,4^ The effectiveness in removing ingested materials
declines with time and is greatly diminished after 30 minutes. Emesis
can reduce a toxic burden by about one half if it occurs within 60
minutes, but when ipecac syrup is administered 90 minutes or more after
a toxin is ingested, there is no identifiable benefit.^5^ Some studies
fail to demonstrate that ipecac syrup improves patient outcome.^6^ Most
studies exclude the use of ipecac syrup in life-threatening
intoxications, so it is difficult to determine the benefit of ipecac
syrup in those situations.^3^ The position statement of the American
Academy of Clinical Toxicology stated that, "the data was insufficient
to support or exclude ipecac administration soon after poison
ingestion."^3^

In prospective randomized clinical studies, gastric emptying before
charcoal generally did not improve outcomes over use of charcoal
alone.^7-9^ However, in obtunded patients, lavage before administering
charcoal offered benefit if performed within 1 hour of ingestion as
measured by multiple endpoints that comprised an overall "Clinical
Outcome".^7^ Gastric emptying may delay the administration of
charcoal.^10,11^

**Ipecac Syrup Safety**

The potential complications of the therapeutic use of ipecac syrup are
well documented although serious consequences rarely occur.^3^ Common
adverse effects of ipecac syrup include transient drowsiness or
lethargy, diarrhea. Prolonged vomiting and aspiration can occur. In rare
instances, ingestion of therapeutic amounts of syrup of ipecac have
caused serious adverse effects such as Mallory Weiss tears, gastric
rupture, intestinal perforation, pneumoretroperitoneum,
pneumomediastimum, and intracerebral hemorrhage.^2^

**Ipecac Abuse**

Chronic ingestion of syrup of ipecac by patients with eating disorders
or by children who are victims of Munchausen\'s syndrome by proxy has
resulted in vomiting, irritability, hypothermia, dehydration, hypotonia,
muscle weakness, skeletal muscle myopathy, diarrhea, elevated CK and/or
aldolase levels, cardiomyopathy, tachycardia, prolonged QT interval, and
premature atrial and ventricular contractions. Deaths have been reported
from cardiomyopathy due to chronic ipecac abuse.^12^

# Position Statements

The AACT and the European Association of Poison Centers and Clinical
Toxicologists reviewed the scientific literature and issued a position
statement in 1997 on ipecac syrup which stated that^3^:

-   Ipecac should not be administered routinely in management of
    poisoning.

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-   Data is lacking to demonstrate that ipecac improves the outcome of
    poisoned patients and its routine administration in the emergency
    room should be discontinued.

-   There is insufficient clinical data to support or exclude ipecac
    administration soon after poison ingestion.

-   Ipecac may delay administration or reduce effectiveness of charcoal,
    oral antidotes, and whole bowel irrigation.

-   Ipecac should not be administered to patients with decreased level
    of consciousness or impending loss of consciousness, or to patients
    who have ingested corrosives or hydrocarbons with high aspiration
    potential.

This statement has been endorsed by the American Board of Applied
Toxicology and the Canadian Association of Poison Control Centers. As of
the year 2000, it had not been endorsed by the American College of
Emergency Physicians, or the American Academy of Pediatrics.^4^

The American College of Emergency Physicians\' website recommends that
households should \"Keep a small bottle of Syrup of Ipecac on hand...
but use only if directed by a physician or a Poison Control
Center\".^4,13^ Likewise the American Medical Association (AMA) website
supports advising parents of young children to have a one-ounce bottle
of syrup of ipecac in the medicine cabinet to use in the event of
accidental poisoning, with a label indicating the name of the substance,
the proper dosage and the contraindications to its use. The AMA
recommends that a physician, an emergency room, or a poison control
center be called for advice before administering syrup of
ipecac.^4,\ 14^ The AMA website also states that syrup of ipecac should
continue to be available to the public as a non-prescription item.^15^

**References**

1.  Shannon et al. Ingestion of Toxic Substances by Children. NEJM 2000,
    342(3): 186-191

2.  Ipecac Syrup. Drugdex Drug Evaluations. Micromedex Systems.
    Retrieved 16 May 2003 at
    <http://csi.micromedex.com/DKS/DATA/DE/DE0067.HTM?Top=Yes>

3.  American Academy of Clinical Toxicology, European Association of
    Poisons Centres and Clinical Toxicologists. Position statement:
    Ipecac Syrup. J. Toxicol Clin Toxicol 1997, 35(7): 699-709

4.  Quang LS et al. Past, present, and future role of ipecac syrup.
    Current Opinion in Pediatrics 2000, 12:153-162

5.  Bond GR et al. Influence of Time until Emesis on the Efficacy of
    Decontamination Using Acetaminophen as a Marker in a Pediatric
    Population. Ann Emer Med 1993, 22:403-7

6.  Krenzelok EP. New developments in the therapy of intoxications.
    Toxicology Letters 2002, 127: 299-305

7.  Kulig K et al. Management of Acutely Poisoned Patients without
    Gastric Emptying. Ann Emer Med 1985, 14:562-7

8.  Merigian KS et al. Prospective Evaluation of Gastric Emptying in the
    Self-Poisoned Patient. Ann Emer Med 1990, 8(6):479-83

9.  Pond SM et al. Gastric emptying in acute overdose: a prospective
    randomised controlled trial. Med J Aust 1995, 163:345-9

10. Kornberg AE. Pediatric Ingestions: Charcoal Alone versus Ipecac and
    Charcoal. Annals of Emer Med 1991, 20(6): 648-651

11. Albertson TE. Superiority of Activated Charcoal Alone Compared with
    Ipecac and Activated Charcoal in the Treatment of Acute Toxic
    Ingestions. Ann Emer Med 1989, 18(1): 56-59

12. Ipecac. Toxicologic Managements. Micromedex Systems. Retrieved 16
    May 2003 at

> <http://csi.micromedex.com/DKS/DATA/MG/MG0150.HTM?Top=Yes>

13. How to Protect Your Child from Poison. Retrieved 16 April 2003 at
    [www.acep.org/1,194,0.html](http://www.acep.org/1,194,0.html)

14. H-60998 Ipecac as Household Poison Emetic. Retrieved 16 April 2003
    at
    [www.amaassn.org/apps/pf_online/pf_online?f_n=browse&doc=policyfiles/HOD/H-60.998.HTM](http://www.amaassn.org/apps/pf_online/pf_online?f_n=browse&doc=policyfiles/HOD/H-60.998.HTM)

15. H 60.995 Accidental Ingestions. Retrieved 16 April 2003 at
    [www.ama-assn.org/apps/pf_online/pf_online?f_n=browse&doc=policyfiles/HOD/H-60.995.HTM](http://www.ama-assn.org/apps/pf_online/pf_online?f_n=browse&doc=policyfiles/HOD/H-60.995.HTM)