OR WAIT null SECS
A reader discusses concerns about use of the over-the-counter drug ipecac among adolescents.
I attended the FDA meeting covered in the February 2008 "Eye on Washington" article about over-the-counter (OTC) drugs, and was impressed by the quality of the research presentations at that meeting. However, I was very disappointed that the meeting did not address the most serious OTC issue: the grave danger of ipecac.
Ipecac originally was indicated for the early treatment of poisoning. Its effectiveness and safety have been repeatedly questioned. Ipecac is no longer used in Europe, nor is it recommended by the American Academy of Clinical Toxicology, the European Association of Poison Centers, or the American Academy of Pediatrics.1,2 Moreover, as has been testified for the FDA, it is well-known that adolescents suffering from eating disorders may self-induce vomiting with ipecac.3
Mercifully, if ipecac use stops, the muscular and cardiac injury it can cause may be reversible.8 Thus, making ipecac unavailable as an OTC medication may not only prevent injury and death, but may also allow recovery from the damage sustained by its compulsive use.
The concerns about ipecac's usefulness in the management of poisoned patients, coupled with the morbidity and mortality associated with its abuse, led the FDA Center for Drug Evaluation and Research to hold hearings on ipecac in 2003. Following these hearings, the FDA panel of experts recommended that the OTC status of ipecac be revoked.9 The FDA has not yet followed through on this recommendation and has not produced a final ruling.
To summarize: ipecac has outlived its clinical-toxicology indications, it has become a substance of abuse-a "bulimic's drug"-and it continues to cause serious morbidity and mortality. For all of these reasons, pediatricians and many others involved in taking care of patients with eating disorders continue to strongly urge the FDA to include in its OTC agenda for adolescents the removal of ipecac from its current OTC status.
Tomas J. Silber, MD Director, Office of Ethics, Children's National Medical Center (CNMC) Director, Adolescent Medicine Fellowship, CNMC, Director, Donald Delaney Eating Disorders Program, Professor of Pediatrics, George Washington University
1. Krenzelok EP, McGuigan M, Lheur P: Position statement: ipecac syrup. American Academy of Clinical Toxicology, European Association of Poison Centers and Clinical Toxicologists. J Toxicol Clin Toxicol 1997;35:699
2. American Academy of Pediatrics. Poison treatment in the home. Pediatrics 2003;112:1182
3. Silber TJ: Ipecac syrup abuse, morbidity and mortality: isn't it time to repeal its over-the-counter status? J Adol Health 2005;37:256
4. Lee L: ODS Postmarketing survey (PID No. D030159) Ipecac executive summary. Center for Drug Evaluation and Research, FDA, May 6, 2003.
5. Pope HG Jr, Hudson JI, Nixon RA, et al: The epidemiology of ipecac abuse. N Engl J Med 1986;314:245
6. Greenfeld D, Mickley D, Quinlon DM, et al: Ipecac abuse in a sample of eating disordered outpatients. Int J Eat Disord 1993;13:411
7. Fisher M, Schneider M, Burns J, et al: Differences between adolescents and young adults at presentation to an eating disorders program. J Adol Health 2001;28:222
8. Ho PC, Dweik R, Cohen MC: Rapidly reversible cardiomyopathy associated with chronic ipecac ingestion. Clin Cardio 1998;21:780
9. Mechcatie E: FDA panel: ipecac OTC status should be revoked. Ped News 2003;7:30