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ARTICLE |

Adverse Events Associated With Ephedrine-Containing Products— Texas, December 1993-September 1995 FREE

JAMA. 1996;276(21):1711-1712. doi:10.1001/jama.1996.03540210019010
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DURING December 1993-September 1995, the Bureau of Food and Drug Safety, Texas Department of Health (TDH), received approximately 500 reports of adverse events in persons who consumed dietary supplement products containing ephedrine and associated alkaloids (pseudoephedrine, norephedrine, and N-methyl ephedrine). This total included reports by individuals and reports identified by the Bureau of Epidemiology, TDH, in a review of records from the six centers of the Texas Poison Center Network.

Reported adverse events ranged in Severity from tremor and headache to death in eight ephedrine users and included reports of stroke, myocardial infarction, chest pain, seizures, insomnia, nausea and vomiting, fatigue, and dizziness. Seven of the eight reported fatalities were attributed to myocardial infarction or cerebrovascular accident. This report describes three patients in which the recommended dosage for the dietary supplements reportedly was not exceeded, summarizes results from ongoing investigations, and underscores the potential health risks associated with

REFERENCES

Dollery C, ed.  Ephedrine (hydrochloride) . In: Therapeutic drugs . Vol 1. New York: Churchill Livingstone, 1991;:E26-E29.
Pentel P.  Toxicity of over-the-counter stimulants . JAMA 1984;;252:1898-903.
Loizou LA, Hamilton JG, Tsementzis SA.  Intracranial haemorrhage in association with pseudoephedrine overdose . J Neurol Neurosurg Psychiatry 1982;;45:471-2.
Lake CR, Gallant S, Masson E, Miller P.  Adverse drug effects attributed to phenylpropanolamine: a review of 142 case reports . Am J Med 1990;;89:195-208.
Breum L, Pedersen JK, Ahlstrom F, Frimodt-Moller J.  Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity: a double-blind, multi-centre trial in general practice . International Journal of Obesity and Related Metabolic Disorders 1994;;18:99-103.
Astrup A, Lundsgaard C, Madsen J, Christensen NJ.  Enhanced thermogenic responsiveness during chronic ephedrine treatment in man . Am J Clin Nutr 1985;;42:83-94.
Astrup A, Toubro S.  Thermogenic, metabolic, and cardiovascular responses to ephedrine and caffeine in man . International Journal of Obesity and Related Metabolic Disorders 1993;;17 ( (suppl) ):S41-S43.
Astrup A, Toubro S, Cannon S, Hein P, Breum L, Madsen J.  Caffeine: a double-blind, placebo-controlled study of its thermogenic, metabolic, and cardiovascular effects in healthy volunteers . Am J Clin Nutr 1990;;51:759-67.
60 FR 38643.

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Dollery C, ed.  Ephedrine (hydrochloride) . In: Therapeutic drugs . Vol 1. New York: Churchill Livingstone, 1991;:E26-E29.
Pentel P.  Toxicity of over-the-counter stimulants . JAMA 1984;;252:1898-903.
Loizou LA, Hamilton JG, Tsementzis SA.  Intracranial haemorrhage in association with pseudoephedrine overdose . J Neurol Neurosurg Psychiatry 1982;;45:471-2.
Lake CR, Gallant S, Masson E, Miller P.  Adverse drug effects attributed to phenylpropanolamine: a review of 142 case reports . Am J Med 1990;;89:195-208.
Breum L, Pedersen JK, Ahlstrom F, Frimodt-Moller J.  Comparison of an ephedrine/caffeine combination and dexfenfluramine in the treatment of obesity: a double-blind, multi-centre trial in general practice . International Journal of Obesity and Related Metabolic Disorders 1994;;18:99-103.
Astrup A, Lundsgaard C, Madsen J, Christensen NJ.  Enhanced thermogenic responsiveness during chronic ephedrine treatment in man . Am J Clin Nutr 1985;;42:83-94.
Astrup A, Toubro S.  Thermogenic, metabolic, and cardiovascular responses to ephedrine and caffeine in man . International Journal of Obesity and Related Metabolic Disorders 1993;;17 ( (suppl) ):S41-S43.
Astrup A, Toubro S, Cannon S, Hein P, Breum L, Madsen J.  Caffeine: a double-blind, placebo-controlled study of its thermogenic, metabolic, and cardiovascular effects in healthy volunteers . Am J Clin Nutr 1990;;51:759-67.
60 FR 38643.
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