On Dec. 30, 2003, the FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products. Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. Also on Dec. 30, FDA notified manufacturers that it intends to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication.
Can cause insomnia, dry mouth, nervousness, general weakness, poor digestion, irritability, headache, and
dizziness. Do not take ephedra
if you are pregnant, nursing or have heart disease, anxiety disorder (panic
attacks), high blood pressure, diabetes, glaucoma, or an overactive thyroid
gland (hyperthyroidism). Do not take ephedra
if you are taking monoamine oxidase (MAO) inhibitor drugs, commonly prescribed
- Murray, M. -- The Pill Book Guide to Natural Medicines: Vitamins, Minerals, Nutritional Supplements, Herbs, and Other Natural Products. -- Bantam, 2002. 633-636.
The Food and Drug Administration recommends that ephedra be avoided in patients with high blood pressure, heart disease, thyroid disease, diabetes, and benign prostatic hypertrophy. Caution is also recommended against use for pregnant, nursing patients or those with anorexia, insomnia, depression, diabetes, hyperthyroidism, gastric ulcers, bulimia, glaucoma, children, or use longer than one week. Discontinue use if nervousness, tremor, sleeplessness, anorexia, or nausea occurs.
Case report of a reservist who presented for a physical examination with hypertension. It was discovered that the reservist was unknowingly taking large doses of Ephedra sinica, or ma huang, a Chinese herbal supplement, for body-building. One of the ingredients in ma huang is ephedrine, an active alpha- and beta-adrenergic stimulant that produces increases in heart rate, blood pressure, and cardiac output. Ma huang has been reported to cause hypertension, hepatitis, nephrolithiasis, and sudden death in healthy, normotensive people.
- Mil Med 2002 Jun;167(6):521-3 -- A mysterious blood pressure increase in a drilling Naval reservist. -- Wettach GE, Falvey SG.
Analysis of the 37 patients indicates the following findings: (1) ma huang use is temporally related to stroke, myocardial infarction, and sudden death; (2) underlying heart or vascular disease is not a prerequisite for ma huang-related adverse events; and (3) the cardiovascular toxic effects associated with ma huang were not limited to massive doses. Although the pathogenesis of the cardiac toxic effects of ma huang remains incompletely defined, available observational and circumstantial evidence indicates that use of the substance may be associated with serious medical complications.
- Mayo Clin Proc 2002 Jan;77(1):12-6 -- Adverse cardiovascular events temporally associated with ma huang, an herbal source of ephedrine. -- Samenuk D, Link MS, Homoud MK, Contreras R, Theohardes TC, Wang PJ, Estes NA 3rd.
A case of a young user of Thermadrene, an herbal remedy for weight loss, was studied. We believe that Thermadrene can cause serious complications such as ischemic stroke. Because these remedies are available over the counter and are not regulated by the Food and Drug Administration or similar organizations, there is a need for critical scrutiny of their content and side effects, as is performed for other pharmaceuticals.
- Clin Pharmacol Ther 2002 Sep;72(3):343-6 -- Ischemic stroke in a user of thermadrene: a case study in alternative medicine. -- Kaberi-Otarod J, Conetta R, Kundo KK, Farkash A.
A report on the case of Leber hereditary optic neuropathy in a patient who was using ephedra alkaloids at the time of onset of his optic neuropathy.
- Am J Ophthalmol 2002 Dec;134(6):918-20 -- Leber hereditary optic neuropathy associated with use of ephedra alkaloids. -- Warner RB, Lee AG.
Report on a case in which a patient with schizophrenia began using Metabolife, an herbal preparation containing ephedra, for weight reduction and subsequently developed an exacerbation of his psychosis with superimposed delirium.
- Psychopharmacol Bull 2002 Summer;36(3):42-5 -- Psychosis and delirium following metabolife use. -- Verduin ML, Labbate LA.
The combination therapy of Ephedra herb and Loxoprofen caused gastric mucosal lesions and loss of body weight. It is considered that this combination therapy should be avoided because of its adverse effects.
- Am J Chin Med 2002;30(4):571-7 -- The combination therapy of Ephedra herb and Loxoprofen caused gastric lesions in mice. -- Cho S, Hong T, Jin GB, Yoshino G, Miura M, Aikawa Y, Yasuno F, Cyong JC.
Anecdotal, uncontrolled observations suggest that herbal stimulants containing ephedrine (ephedra or ma huang) and caffeine (cocoa, coffee, tea, mate, guarana, cola or kola) can exacerbate seizures in people with epilepsy, especially when taken in combination.
- 2001 Dec;2(6):524-532 -- Herbal Medicines and Epilepsy: The Potential for Benefit and Adverse Effects. -- Spinella M.