Ipecac Abuse
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Ipecac Abuse Tomas J Silber, MD, MASS Children’s National Medical Center Division of Adolescent Medicine Department of Pediatrics, GWU PowerPoint PPT Presentation

Ipecac Abuse Tomas J Silber, MD, MASS Children’s National Medical Center Division of Adolescent Medicine Department of Pediatrics, GWU. Presentation for the Center for Drug Evaluation and Research Office of executive Programs, US Food and Drug Administration June 12, 2003.

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Ipecac abuse

Ipecac AbuseTomas J Silber, MD, MASSChildren’s National Medical Center Division of Adolescent Medicine Department of Pediatrics, GWU

Presentation for the

Center for Drug Evaluation and Research

Office of executive Programs, US Food and Drug Administration

June 12, 2003


Review of ipecac syrup for otc status 21 cfr 201 308

Review of Ipecac Syrup for OTC Status (21 CFR 201.308)

  • Role in gastrointestinal decontamination

  • Risk benefit ratio

  • Role in the treatment for populations with limited access to emergency medical treatment

  • Abuse of ipecac syrup

  • Alternative therapies

Abuse of ipecac syrup


Ipecac abuse

Ipecac Abuse: DefinitionIpecac abuse consists of the repeated use of the syrup for the sole purpose of self-inducing emesis as a method of weight control


Ipecac abuse adolescent and young adult population

Ipecac Abuse=Adolescent and Young Adult Population

  • Experimenters

  • Eating Disorder, NOS

  • Anorexia Nervosa, purging type

  • Bulimia Nervosa

Secret

Addictive

Denial

Lying


Epidemiology of self induced vomiting

Epidemiology of Self-Induced Vomiting*

  • Anorexia Nervosa: Prevalence, lifetime 0.1 to 1%

  • Between 8 to 41% of individuals with Anorexia Nervosa with develop Bulimia Nervosa

    (Bulik CM: Eating Disorders in adolescents and young adults. Child and Adol Psychiatri Clin N Am 2002(11):201-218.)

  • Bulimia Nervosa: Prevalence, lifetime 3%

    (Fairburn CG, Beglin SJ: Studies of the epidemiology of bulimia nervosa. Am J Psychiatry 1990;147:401-408.)

    *There is no data on the incidence and prevalence of the use of ipecac to self-induce vomiting.


Adverse events ae

Adverse Events (AE)

  • OTC do not require submission of AE to the FDA

  • Therefore, AE data are very limited

  • However, all reports are consistent with Ipecac’s characteristic effects


Signs and symptoms of ipecac poisoning

Recurrent vomiting

Diarrhea

Abdominal cramping

Muscle pain and stiffness

Muscle weakness

Myopathy

Erythema

Urticaria

Edema

Cardiomyopathy

Cardiac insufficiency

Cardiac arrhythmias

Signs and Symptoms of Ipecac Poisoning*

Death - n=6 (4 due to ipecac abuse)

*Lee L, Karwoski C: Post-Marketing Safety Review - PID# D030159 - May, 6, 2003


Recurrent vomiting dental abnormalities

Recurrent Vomiting: Dental Abnormalities

  • Tooth enamel dissolves

  • Sensitive teeth

  • Increased caries

  • Pyorrhea, periodontal disease

  • Loss of teeth

  • Parotid gland enlargement


Recurrent vomiting gastrointestinal abnormalities

Recurrent Vomiting: Gastrointestinal Abnormalities

  • Esophagitis

  • Reflux

  • Barrets esophagus

  • Dysphagia - odynophagia

  • Esophageal strictures

  • Mallory Weiss Tears

  • Hematemesis

  • Aspiration pneumonitis


Recurrent vomiting metabolic abnormalities

Recurrent Vomiting: Metabolic Abnormalities

  • Metabolic alkalosis

  • Hypokalemia: fatigue, muscle weakness, polydipsia, nocturia, abdominal pain, constipation, headaches, palpitations, renal pathology (Barters Syndrome)

  • Dehydration - shock

  • Sudden death


Diarrhea

Diarrhea

  • Dehydration

  • Secretory diarrhea

  • Hemorrhagic colitis

  • Pseudo melanosis

  • Intestinal pseudo-obstruction


Myopathy

Myopathy

  • Progressive weakness in proximal muscles

  • Myalgia

  • Loss of deep tendon reflexes

  • Swallowing difficulty

  • Slurred speech


Myopathy1

Myopathy*

  • Persistent increase in phosphokinase and aldolase

  • Electromyographic features of toxic myopathy

  • Muscle biopsy: severe disruption of sarcomeres sarcotubular lesions

  • Electron microscopy: foci of Z-band degeneration

    *Reversible with cessation of use


Cardiac abnormalities

Cardiac Abnormalities

  • Cardiomyopathy

  • Cardiomegaly

  • Tricuspid and mitral valve insufficiency

  • Decreased cardiac ejection fraction

  • Hypotension

  • Arrhythmias

  • Death


Ekg changes

EKG Changes

  • Sinus tachycardia

  • T wave depression and inversion

  • Prolonged PR interval and QTc

  • Atrial tachycardia

  • Atrial premature beats

  • Ventricular tachycardia

  • Ventricular fibrilation


Ipecac abuse

Echocardiography:

Ventricular dysfunction

Reduced ejection fraction

Electron microscopy of myocardium:

Zones of myofibrillar lysis

Fragmented fibers

Irregular alignments or clumps of Z bands


Miscellaneous

Miscellaneous

  • Pneumomediastinum

  • Pneumoperitoneum

  • Intestinal perforation

  • Hepatic toxicity

  • Cerebral hemorrhage

  • Seizures


Munchausen syndrome by proxy

Munchausen Syndrome by Proxy

  • Child abuse by poisoning

  • Increasingly reported but probably underrecognized

  • Severe recurrent pathology

  • May end by causing the death of the child


Detection

Detection

  • High index of suspicion

    Laboratory

    EKG

    CPK-aldolase

    Confirmation

    (high performance liquid chromatography)

    In serum

    In urine

    In tissue


Recommendations

Recommendations

  • Studies are needed to determine incidence and prevalence of ipecac abuse

  • Promote professional education re: ipecac abuse to facilitate early detection and treatment

  • Develop preventive methods. Depending on risk-benefit ration, this may include status change from OTC to prescription medication, and/or

  • Warnings about the danger of abuse should be included

  • Labeling should indicate the maximum total dose or maximum number of times the dose should be repeated


Example of warnings

Example of Warnings

  • Use of ipecac to repeatedly self-induce vomiting is hazardous to your health.

  • Prolonged use of ipecac is poisonous and can induce among others muscle weakness and pain secondary to muscle destruction.

  • Ipecac toxicity can lead to cardiac damage, electrolyte imbalance and death.

  • If you are or have abused ipecac, seek professional advice.


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