Over-the-Counter Status of Ipecac Should Be Withdrawn

Position Statement: Over-the-Counter Status of Ipecac Should Be Withdrawn

Tomas Jose Silber, M.D., M.A.S.S.
Margo Maine, PhD.
Beth Mc Gilley, PhD.

Position:

It is imperative that the United States Food and Drug Administration (FDA) withdraw the over-the-counter (OTC) status of Ipecac. Ipecac is an emetic agent that can be misused by people with eating disorders to self-induce vomiting. This type of misuse may result in serious medical complications, including death secondary to cardiotoxicity [1-3]. Moreover, the single medical indication for the use of Ipecac-- the early treatment of poisoning-- is no longer recommended by the American Academy of Clinical Toxicology, the European Association of Poison Centers and Clinical Toxicologists, or by the American Academy of Pediatrics [5,6]. Therefore, the Academy for Eating Disorders urges the FDA to withdraw the OTC status of Ipecac.

Commentary:

Ipecac is sold OTC in the United States, in 30 ml bottles containing approximately 21 mg of emetine base [1]. It is well-known that persons afflicted with eating disorders may engage in self- induced vomiting with Ipecac [1,2].  It is difficult to estimate the morbidity and mortality caused by Ipecac abuse among patients with eating disorders, since this is a secret and surreptitious practice. Nevertheless, there is clear and consistent evidence for misuse of Ipecac among patients seen in e ating d isorders p rograms, which has remained consistent over three decades [1,7-8].  If one extrapolates from these data to the entire population, the numbers of those who experiment with, use, and/or abuse Ipecac may indeed be very concerning.

Ipecac is efficacious as an emetic: 85% of those who use it vomit after one dose, 95% after two doses [1,2]. Research has long ago shown that an accumulated dose of only 1.25 grams can result in myopathy and cardiomyopathy [2]. Thus, it comes as no surprise that, with repeated intake, Ipecac is absorbed sufficiently to cause severe complications and even death [1-3].  However, after Ipecac use stops, the muscular and cardiac injury it can cause may be reversible [4]. Thus, withdrawing the OTC status of Ipecac may not only prevent injury and death, but may also allow for recovery from the damage sustained by its inappropriate and prolonged use.

The single medical indication for the use of Ipecac was for the early treatment of poisoning. This practice is now considered obsolete [5,6,9].  In fact, the effectiveness and safety of Ipecac have been repeatedly questioned [5,6]. It is no longer used in Europe, and, as of ten years ago, its use was no longer recommended by leading organizations, such as the American Academy of Clinical Toxicology and the European Association of Poison Centers [5]. In 2003, the American Academy of Pediatrics no longer recommended its use for poisonings occurring in the home [6].  These official statements about its lack of 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. Following these hearings, the FDA panel of experts recommended that the OTC status of Ipecac be withdrawn [11]. However, the FDA has not yet followed through on this recommendation and has not produced a final ruling.

Ipecac has outlived its clinical-toxicological indications [5,6,9]. It has remained a substance of abuse for individuals with eating disorders [7,8], and it is associated with serious morbidity and mortality [2,3]. However, the bodily harm it causes can often be reversed upon ceasing its use [4]. For all of the above reasons, the Academy for Eating Disorders strongly urges the United States Food and Drug Administration to withdraw the OTC status of Ipecac.

References:

  1. Steffen KJ, Mitchell JE, Roerig JL, Lancaster KL. The eating disorders cabinet revisited: a clinicians guide to Ipecac and laxatives. Int J Eat Disord 2007;40;360-368.
  2. Silber TJ. Ipecac syrup abuse, morbidity and mortality: isn’t it time to repeal its over the counter status? J Adol Health 2005;37;256-260.
  3. Lee L. ODS Postmarketing Survey (PID No D030159 ) Ipecac Executive Summary Center for Drug Evaluation and Research, FDA, May 6th, 2003.
  4. Ho PC, Dweik R, Cohen MC. Rapidly reversible cardiomyopathy associated with chronic ipecac ingestion. Clin Cardio 1998;21;780-783.
  5. Krenzelock EP, Mc Guigan 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;35:699-709.
  6. American Academy of Pediatrics. Poison treatment in the home. Pediatrics 2003;112:1182-5.
  7. Greenfeld D, Mickley D, Quinlon DM, Roloff P. Ipecac abuse in a sample of eating disordered outpatients. Int J Eat Disord 1993;13:411-414.
  8. Fischer 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;222-227.
  9. Meckatie EP FDA Panel: Ipecac OTC status should be revoked. Pediatric News, July 2003, p.30.

 

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