COMMENTARY |
The Demise of Ipecac
Program in Medical Toxicology Division of Emergency Medicine Children’s Hospital/Harvard Medical School Boston, MA 02115
Abbreviations: FDA, Food and Drug Administration
In 1965, at the urging of 4 organizations (the American Academy of Pediatrics, the American Medical Association, the American Association of Poison Control Centers, and the Food and Drug Administration’s [FDA’s] Medical Advisory Board), the FDA agreed to grant syrup of ipecac over-the-counter status.1,2 Over the previous 12 years, pediatricians and toxicologists were persuaded that the drug was both safe and effective for treatment of childhood poisonings, justifying its unrestricted availability. In 1985, the Academy recommended that ipecac be discussed with and given to parents at the 6-month (infant) visit.3,4 Although the efficacy of ipecac at improving outcome after childhood poisoning had not been rigorously proven and despite reports of failures,5 adverse outcomes,6,7 and even malicious use, the medication became an integral part of pediatric anticipatory guidance. Widespread use of ipecac in poisoned children was strongly advocated both because of its apparent ability to reduce morbidity and because it significantly reduced the need for emergency department referral.8,9 Erroneously, ipecac’s clinical effectiveness was often equated with its ability to produce vomiting, which occurred in 85% to 100% of recipients.2
But the evidence against ipecac efficacy began to mount. Although there were well-designed studies suggesting potential value,9 the weight of evidence firmly pointed to a lack of clinical benefit.10,11 Additionally, continuing reports of adverse events, ipecac abuse by bulimics12,13 and even its use as an agent for Munchausen’s syndrome by proxy14 forced toxicologists and other poison specialists to reexamine the role of ipecac in poisoning treatment. As questions persisted, clinical practice quickly began to change; ipecac virtually disappeared from emergency departments as its use was discouraged.15,16 Because the number of ingestions for which ipecac is contraindicated continued to grow, poison centers across the nation increasingly referred poisoned children to emergency departments for assessment and administration of activated charcoal rather than recommending ipecac and home monitoring. The results have been striking; data from the American Association of Poison Control Centers indicate that the use of ipecac has fallen by >95% over a 15-year period (from 15% of childhood poisonings in 1985 to 7% in 1989 to 0.7% in 2001).17,18 Finally, a critical assessment of ipecac led in 1997 to publication of a consensus statement by the American Academy of Clinical Toxicology, which concluded there was no firm evidence to indicate that ipecac had a role in treatment of the poisoned patient.19
Against this background, the study by Bond in this month’s issue of Pediatrics indicates that ipecac’s cost-effectiveness must also be questioned. The main finding of the study was that the administration of ipecac to children with toxic ingestions did not reduce the rate of referral to emergency departments for evaluation and further management. Interestingly, in 1983 and 1995 investigations by Chafee-Bahamon20 and Bond,21 respectively, opposite findings were reported; ipecac administration resulted in fewer emergency department visits, producing substantial cost savings. There are a number of potential explanations for the dramatic change in practice around ipecac use and emergency department referral. The recent emphasis on activated charcoal administration as the primary (if not sole) treatment for poisoning has led to an intervention that typically necessitates a visit to the emergency department. The referral of children for emergency care after they have been given ipecac could be attributed to more conservative practice by poison centers or even increased self-referral by parents to the emergency department despite the poison center’s recommendation for home monitoring. Regardless of explanation, as the current study indicates, a child given syrup of ipecac after a toxic ingestion is likely be referred for medical evaluation, eliminating any cost savings that were once attached to ipecac use.
In June 2003 an Advisory Committee recommended to the FDA that ipecac have its over-the-counter status rescinded, making it available only by prescription (FDA finds ipecac’s risks outweigh benefits. Boston Globe, July 1, 2003). Because the time and cost necessary for a pharmaceutical company to file a New Drug Application for marketing ipecac as a prescription drug are likely to be viewed as prohibitive, FDA acceptance of this recommendation will likely to end ipecac’s 38-year history as a treatment for toxic ingestions. Will children be harmed by the loss of ipecac? Almost certainly not. In many poison centers across the nation and in most countries outside the United States, ipecac use is negligible. Rigorous data indicating that poisoned children in these settings have suffered because of its absence are lacking. And, while most pediatricians and toxicologists can identify at least one case in which ipecac administration might be of value, (eg, ingestion of plants, berries, or mushrooms or a pharmaceutical ingestion in a child who is far from a health care facility), we can no longer claim an evidence-based rationale for keeping ipecac in our medicine cabinets. If it departs, the drug may be missed briefly but it is unlikely that its absence will create more concerns than its presence has.
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FOOTNOTES |
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Received for publication Jul 21, 2003; Accepted Jul 21, 2003.
Address correspondence to Michael Shannon, MD, MPH, The Program in Medical Toxicology, Division of Emergency Medicine, Children’s Hospital/Harvard Medical School, Boston, MA 02115. E-mail: michael.shannon{at}tch.harvard.edu
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REFERENCES |
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 TOP REFERENCES |
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- Ipecac syrup. Vol. OTC 21 CFR 201.308 (1965)
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- Knight KM, Doucet JJ. Gastric rupture and death caused by ipecac syrup. South Med J. 1987; 80: 786–787[CrossRef][Web of Science][Medline]
- American Academy of Pediatrics, Committee on Accident and Poison Prevention. In: American Academy of Pediatrics, ed. Early Childhood Safety Counseling Schedule. The Injury Prevention Program. Elk Grove Village, IL: American Academy of Pediatrics; 1985
- Tenenbein M. Inefficacy of gastric emptying procedures. J Emerg Med. 1985; 3: 133–136[CrossRef][Medline]
- Tandberg D, Liechty EJ, Fishbein D. Mallory-Weiss syndrome: an unusual complication of ipecac-induced emesis. Ann Emerg Med. 1981; 10: 521–523[CrossRef][Web of Science][Medline]
- Woolowodiuk O, McMicken DB, O’Brien P. Pneumomediastinum and retropneumoperitoneum: a unusual complication of syrup-of-ipecac induced emesis. Ann Emerg Med. 1984; 13: 1148–11[CrossRef][Web of Science][Medline]
- Litovitz TL. In defense of retaining ipecac syrup as an over-the-counter drug. Pediatrics. 1988; 82: 514–515
[Abstract/Free Full Text] - Bond RG, Requa R, Krenzelok E, et al. Influence of time until emesis on the efficacy of decontamination using acetaminophen as a marker in a pediatric population. Ann Emerg Med. 1993; 22: 1403–1407[CrossRef][Web of Science][Medline]
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[Abstract/Free Full Text] - Bader AA, Kerzner B. Ipecac toxicity in "Munchausen syndrome by proxy." Ther Drug Monit. 1999; 21: 259–260[CrossRef][Web of Science][Medline]
- American College of Emergency Physicians. Clinical policy for the initial approach to patients presenting with acute toxic ingestion or dermal or inhalation exposure. Ann Emerg Med. 1995; 25: 570–585[CrossRef][Web of Science][Medline]
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[Free Full Text] - Bond GR. Home syrup of ipecac use does not reduce emergency department use or improve outcome. Pediatrics. 2003; 112: 1061–1064
[Abstract/Free Full Text] - Litovitz T, Klein-Schwartz W, Rodgers G, et al. 2001 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med. 2002; 20: 391–352[CrossRef][Web of Science][Medline]
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[Abstract/Free Full Text] - Bond GR. Home use of syrup of ipecac is associated with a reduction in pediatric emergency department visits. Annals Emerg Med. 1995; 25: 338–343
PEDIATRICS (ISSN 1098-4275). ©2003 by the American Academy of Pediatrics
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