Ephedra Alkaloids

About Ephedra Alkaloids and Ma Huang

This website is designed to provide information about the health risks, legal claims and lawsuits that may arise from the use of ephedra alkaloids, known in traditional Chinese medicine as ma huang. Herbal ephedra is sold in about 200 dietary supplements. Our law firm is accepting legal cases against Metabolife International Inc. and other EADS manufacturers to represent individuals who have suffered, experienced stroke and sustained deficits or paralysis, or died as a result of these dangerous central-nervous-system stimulants. We are happy to make some of the information that we have obtained through our investigation of this product available to the public on this website. Some brand names include:

Ephedra Medical Consequences and Frequently Asked Questions

What are ephedra alkaloid dietary supplements (EADS)?

EADS are dietary supplements that contain varying amounts and types of ephedra alkaloids. Alkaloids, in general, are chemical substances that contain nitrogen. Alkaloids often possess strong pharmacological activity and their names usually end in “-ine.” Caffeine, cocaine, morphine, nicotine, and quinine are familiar alkaloids. Metabolife 356 and many other EADS also contain caffeine, which intensifies the supplements’ effects.

There are at least 40 species of evergreen plants that are members of the genus Ephedra. The ephedra plant has a pine-like odor and is also known as the joint fir or joint pine. The dried branchlets of the ephedra plant constitute the Chinese herb ma huang. The ephedra plant contains from 0.5% to 2.5% alkaloids, of which two are clinically important: ephedrine and pseudoephedrine.

How do I know what ingredients are in EADS?

It is difficult to be certain, even when the ingredients are identified on the product’s label. Bill J. Gurley and others studied the content of 20 ephedra-containing dietary supplements and found that the alkaloid content often differed markedly from label claims and was inconsistent even between two lots of the same product. “Half of the products exhibited discrepancies between the label claim for ephedra alkaloid content and actual alkaloid content in excess of 20%.”

Total alkaloid content ranged from 0.0 to 18.5 mg. per dosage unit, with ephedrine ranging from 1.1 to 15.3 mg. and pseudoephedrine ranging from 0.2 to 9.5 mg. The authors of the study warn: “Until GMPs [Good Manufacturing Practices] are in place, consumers intent on purchasing an ephedra supplement are best advised to heed the adage of caveat emptor — let the buyer beware.”

What does Metabolife 356 contain?

According to the label, Metabolife contains herbs, vitamins, minerals, and formulation ingredients. Its most active ingredients are two stimulants: 40 mg. of caffeine alkaloids in the form of guarana (seed) and 12 mg. of ephedrine alkaloid groups in the form of ma huang extract (aerial part).

What is ephedra used for?

Ephedra was traditionally used for diseases of the respiratory tract, such as asthma since ephedrine acts as a bronchodilator, and as a nasal decongestant though prolonged use can cause reboud congention and chronic rhinitis. Other uses have included hives, urinary incontinence, narcolepsy, myasthenia gravis, painful menstruation, and chronic postural hypotension.

However, “ephedrine is rarely prescribed today for medical purposes, because newer drugs have more specific actions and fewer side effects.”

Today, ephedra alkaloids are found in dietary supplements that are promoted and used by approximately 12 million people in the United States to lose weight, boost energy, and enhance athletic performance and endurance.

Is ephedra effective for weight loss?

Most scientists agree that EADS have not been proven effective for long-term weight loss. The summary report for information presented at the August 8-9, 2000 FDA Public Meeting: “Safety of Dietary Supplements containing Ephedrine Alkaloids,” indicates that the “efficacy of ephedra or EADS for weight loss or body building specifically is not supported by a large number of high quality, randomized controlled clinical trials.

The few trials and studies reported at the meeting consisted primarily of small groups (fewer han 150) and short durations of use (6-8 weeks); data on long-term weight loss and maintenance are scarce and may be confounded by calorie-restricted diets.”

Metabolife has pointed to several animal studies and two human studies to support its claims of safety and effectiveness: one at Vanderbilt University and the other at Columbia University. When contacted by Newsweek in August of 1999, “researchers from both studies said that neither was comprehensive enough to support any conclusions about long-term usage of the product . . . Vanderbilt insisted that its name be removed from Metabolife’s promotional materials.”

Most importantly, researchers assert that the risks do not outweigh any benefits. After evaluating 140 reports of ephedra-related adverse events, UCSF senior researcher Christine Haller, MD, concluded that “the potential risks of ephedra are not accompanied by any clear benefits.”

FDA requested Haller and other scientists from the Division of Clinical Pharmacology and Experimental Therapeutics, Departments of Medicine and Biopharmaceutical Sciences, University of California, San Francisco, and the California Poison Control System, San Franciso Division, to analyze ephedra-related adverse events reported between June 1, 1997 and March 31, 1999. Authored by Haller and Neal Benowitz, MD, the team’s analysis was published in the December 21, 2000 issue of the New England Journal of Medicine (NEJM).

Ephedra Medical Issues

What are the effects of ephedra alkaloids?

Ephedrine, the most significant ephedra alkaloid, excites the sympathomimetic system to produce the “fight or flight” response. Ephedrine primarily affects the cardiovascular system, where therapeutic doses cause vasoconstriction, increased cardiac output and heart rate, and increased peripheral resistance, producing a lasting rise in blood pressure (systolic, diastolic, and pulse pressures). The pharmacological action of ephedrine is comparable to amphetamine at about one-fifth of amphetamine’s potency.

What are ephedra’s toxic effects?

The ephedrine alkaloid and, to a lesser degree, the pseudoephedrine alkaloid are responsible for the toxic effects that primarily impact the cardiovascular and central nervous systems. According to Dr. Steven Dentali, a pharmacognosist and member of FDA’s ephedrine alkaloid working group, ephedrine alkaloids are toxic at levels only a few times greater than the therapeutic dose, and particularly sensitive individuals can experience untoward effects even at recommended dosages.

Ephedrine and related alkaloids have been associated with such adverse cardiovascular events as acute myocardial infarction, severe hypertension, myocarditis, lethal cardiac arrhythmias, strokes, and death. Adverse effects of the central nervous system include nervousness, agitation, anxiety, irritability, palpitation, restlessness, weakness, tingling, dizziness, insomnia, psychosis, tremors, and seizures. Other signs of ephedrine toxicity include nausea, vomiting, headache, flushing, numbness and tingling, difficult urination, and precordial pain.

What types of adverse events have been related to the FDA?

The analysis published in NEJM regarding 140 adverse events indicated that: “Thirty-one percent of cases were considered to be definitely or probably related to the use of supplements containing ephedra alkaloids, and 31 percent were deemed to be possibly related. Among the adverse events that were deemed definitely, probably, or possibly related to the use of supplements containing ephedra alkaloids, 47 percent involved cardiovascular symptoms and 18 percent involved the central nervous system.

Hypertension [high blood pressure] was the single most frequent adverse effect (17 reports), followed by palpitations, tachycardia [increased heart rate], or both (13); stroke (10); and seizures (7). Ten events resulted in death, and 13 events produced permanent disability, representing 26 percent of the definite, probably, and possible cases.”

The UCSF scientists stated “health risks are so serious – especially to young, healthy consumers – that federal regulators should immediately set maximum dosages and require stronger warning labels on products that contain the stimulant.”

Neal Benowitz, MD, USCF Professor of Medicine, Psychiatry and Biopharmaceutical Sciences, stated: “We think that as currently marketed these supplements are unreasonably hazardous . . . When used as labeled, ephedrine-containing nutritional supplements present a significant and unreasonable risk of injury.”

What conditions rule out the use of ephedra?

The UCSF researchers stated that, since ephedrine-containing supplements are stimulants, they suspect the supplements should be avoided by individuals with “kidney disease, those with pre-existing heart disease, high blood pressure, overactive thyroid, or psychiatric disorders, and those with autonomic insufficiency – abnormalities in the nerves controlling their cardiovascular system – and those with histories of seizures and diabetes.”

Canada’s Therapeutic Products Programme, analogous to the US FDA, treats ephedra as a medical drug and requires the label to warn patients not to exceed the recommended dosage or take for more than seven days except on the advice of a physician and to consult a physician prior to use if they have heart or thyroid disease, high blood pressure, diabetes, glaucoma, difficulty in urination due to an enlarged prostate gland or if they are taking any prescription drugs.

Does ephedra interact with other substances?

Many ephedra alkaloid products contain caffeine, and many individuals who use EADS also ingest beverages containing caffeine. Caffeine intensifies the effects of ephedrine on the cardiovascular and central nervous systems.

The Physicians’ Desk Reference for Herbal Medicines reports the following interactions: heart rhythm disturbances with heart glycosides or halothane; increased sympathomimetic effect with guanethidine and MAO-inhibitors; and high blood pressure with secale alkaloid derivatives or oxytocin.

Is there a relationship between ephedra and substance abuse?

The May 1999 article “The Hazards of Psychotropic Herbs,” published by the Minnesota Medical Association in Minnesota Medicine, reports that the US Drug Enforcement Administration has known for some time that ephedrine and pseudoephedrine are used in the illegal manufacture of methamphetamine. This should come as no surprise to Michael Ellis, CEO and founder of Metabolife International Inc., who pleaded guilty to charges linking him to an illegal methamphetamine lab in the 1980s and received five years’ probation.