News Update: On December 30, 2003, the U.S. Food and Drug Administration announced that it will ban dietary supplements containing ephedra because of associated health risks such as heart attacks and stroke. The agency intends to issue a final rule prohibiting their sale, which will become effective 60 days after the new rule is published. The FDA also issued a consumer alert on the safety of ephedra, advising consumers to immediately stop buying and using ephedra products. For more information, visit the FDA Web site.
Ephedra, the herbal supplement that has been the subject of controversy for some time, has been the focus of new attention since the February 17th death of Orioles pitching prospect Steve Bechler.
This article takes an in-depth look at ephedra: What it is, related health problems, new restrictions in the works, and more.
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Ephedra is a naturally occurring substance derived from the Chinese herb Ma
Huang. It's primary active ingredient is ephedrine. When chemically synthesized,
ephedrine is regulated as a drug and because it opens the air passages in the
lungs, it is used as a decongestant for the short-term treatment of asthma,
bronchitis, and allergic reactions.
While products containing natural ephedrine have long been used to treat respiratory symptoms (asthma, bronchitis, coughs) in traditional Chinese medicine, ephedra has recently been used for weight loss, enhancing sports performance and increasing energy.
"Within the realm of Chinese medicine, ephedra has been commonly used for colds, fever, and in Chinese formulas to treat asthma and breathing problems," said Lixing Lao, Ph.D., L.AC., director of traditional Chinese medicine research at the University of Maryland Center for Integrative Medicine, located at Kernan Hospital, and associate professor of family medicine at the University of Maryland School of Medicine. "Nowadays it's used to lose weight, which is not indicated in traditional Chinese medicine."
Toxicology tests on Bechler revealed significant amounts of ephedra in his blood, and the dietary supplement was cited as a factor in causing the heatstroke that led to his death.
Ephedra can cause heatstroke for two reasons:
These two factors can predispose people to heatstroke," stated Barish, a nationally known heatstroke expert. "Other amphetamines, stimulants and some over-the-counter drugs also do this."
In Bechler's case, Barish said that several factors led to his death: he took ephedra, it was a warm day and he was exercising. Given that he was also predisposed to heat exhaustion, that is what put him over the top.
According to Barish, Bechler was the first professional baseball player to die from heatstroke; usually football players are at more risk. "But now all bets are off," warns Barish. "If you're taking a drug like ephedra which predisposes you to heatstroke, then anyone can be at risk."
The International Olympic Committee, the National Football League, the National Collegiate Athletic Association, minor league baseball, and the U.S. Armed Forces have all banned the use of ephedra.
Bechler's recent death has prompted action from the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA).
Because ephedra is considered a dietary supplement and not a drug, it is currently not regulated by the FDA. But the FDA recently announced it is taking steps to put restrictions on products containing ephedra, including more stringent label warnings that ephedra can cause heart attack, stroke and death.
Dietary supplements are not regulated the same way drugs are. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA does not review dietary supplements for safety and effectiveness before they are marketed. The law requires proof of harm -- a higher standard than used in prescription drug development -- before the FDA can ban a supplement from the market.
FDA's concerns about dietary supplements containing ephedra arise in part from its mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the nervous system and heart. Like an amphetamine, ephedra stimulates the central nervous system by raising blood pressure and boosting heart rate. It also decreases appetite and makes the user feel energetic.
"Ma Huang (ephedra) is an herb very similar to adrenaline in effect. Ma Huang acts on the same receptors as adrenaline does; therefore it has the same side effects," said Marcos Y. Hsu, N.D., L.AC, a licensed acupuncturist at the University of Maryland Center for Integrative Medicine.
Severe side effects from ephedra are possible -- including a risk of seizures, strokes, and heart attack -- but according to Hsu, most side effects can be attributed to overdose and abuse.
The primary risk involves people who have other conditions such as heart disease, high blood pressure, and a history of seizures or stroke. In addition, ephedra may also worsen other conditions such as anxiety, and interfere with diabetes by affecting blood sugar control.
According to the FDA, ephedra has been linked to 117 deaths and 1,500 reports of health problems including strokes, heart attacks and seizures. In addition, a recent RAND Corporation study also raised safety concerns about ephedra and ephedrine.
The Rand study's review of some 16,000 adverse event reports revealed two deaths,
four heart attacks, nine strokes, one seizure and five psychiatric cases involving
ephedra where no other contributing factors were identified. The study also
concluded that ephedra is associated with side effects such as nausea, vomiting,
jitteriness, and heart palpitations, and suggests a link between ephedra products
and catastrophic events such as sudden death, heart attack or stroke.
A study published in the February 2003 Annals of Internal Medicine found that although ephedra products make up less than one percent of all dietary supplement sales, these products account for 64 percent of adverse events associated with dietary supplements.
In addition to enhancing sports performance, many people use ephedra as a weight loss aid. But in fact, many doctors don't recommend using ephedra for this purpose.
"I would never suggest using ephedra for weight loss," said Maggie Covington, M.D., assistant clinical professor at the University of Maryland School of Medicine and director of education at the University of Maryland Center for Integrative Medicine. "Ephedra is not a panacea for weight loss. Some have had temporary success with it, but in my mind the potential risk is too high."
Instead, she says, people with weight issues should address the whole picture, such as lifestyle, diet, exercise and emotional issues.
Alan Shuldiner, M.D., of the University of Maryland's Joslin Diabetes Center and head of the division of endocrinology, diabetes and nutrition at the University of Maryland School of Medicine, agrees.
"Ephedra does seem to be effective in weight loss, but there's also a lot of risk. There's a marked risk of fatal cardiovascular events, so I don't recommend using it," said Shuldiner.
In the short term, ephedra helps with weight loss because it is a stimulant. It increases the body's metabolic rate by stimulating muscle, fat and other tissues. But the risks include the possibility of heart attack, seizures and stroke.
While some doctors may not recommend ephedra for weight loss, there are two FDA approved drugs that are commonly used for this purpose -- Meridia and Xenical. Meridia decreases the appetite and makes it potentially easier to maintain a low-calorie diet, while Xenical inhibits fat absorption.
Both are prescribed by a doctor, but they need to be used in conjunction with lifestyle modifications such as diet and exercise. Basically, Shuldiner says weight loss all comes back to lifestyle changes.
"Maintain a well-balanced diet and pay attention to portion sizes, as opposed to being taken in by any of these fad diets," advised Shuldiner.
One problem with ephedra, as well as other dietary supplements, is that the amount of ephedra in a supplement can sometimes differ from the amount stated on the label. Since these supplements are not regulated, the labels may not always accurately reflect the actual dosage in the medicine.
A study conducted by The American Society of Health System Pharmacists clearly illustrates this point. The study evaluated 20 different products containing ephedra. The results showed wide variation in the amount of ephedra in the supplements, and the actual amount in the products often differed markedly from the amount stated on the label.
Hsu, a licensed acupuncturist at the Center for Integrative Medicine, thinks that more accurate and exact labeling is needed.
"Guidelines such as the Australian GMP (Good Manufacturing Practice) regulations should be considered and created for all herbal products," said Hsu. There is currently no U.S. GMP to assure the quality of herbal products manufactured in the U.S. or overseas.
When taking ephedra, the risk of side effects are dose dependent -- the higher the dose you take the more likely you are to get into trouble.
In addition, people may not know the proper dosage to take, and some may already be taking other medicines (such as over-the-counter medications) that contain ephedra.
"It's very common to take more than one pill to overdose," said Lao. "If you buy three brands of products for weight loss, for example, and if all three contain ephedra, that means you double or triple your dose. People assume if the product is a different name it has different ingredients, but sometimes they overlap."
Another problem is that with high doses and chronic use, the body develops a tolerance for ephedra. As a result, people may take more of it, which can cause problems with the cardiovascular system.
It is also important to note that many ephedra products also contain caffeine or other stimulants; and that combination increases the chances of adverse side effects dramatically. The combination of ephedra and caffeine can increase the risk of more serious adverse effects such as heart attack, hypertension, seizures and strokes.
According to various reports, the use of ephedra and other stimulant herbs
such as those containing caffeine can also increase the risk of common side
effects such as insomnia, jitteriness, tremulousness, and dizziness.
Some herbs and supplements with significant caffeine content include black tea, coffee, Kola Nut, green tea, Guarana, Yerba mate, and others.
Currently there is no solid manufacturing practice established for over-the-counter supplements. In addition, herbs contain active substances that can trigger side effects and that can interact with other herbs, supplements, or medications. For these reasons, ephedra and other herbs should be taken with care, under the supervision of a practitioner knowledgeable in the field of botanical medicine.
"Before taking ephedra, I would suggest someone first consult with a physician as well as a knowledgeable herbalist," said Lao, director of traditional Chinese medicine research at the University of Maryland Center for Integrative Medicine. "Check with your doctor to make sure ephedra is not contraindicated with another medicine you're taking. Ephedra, especially in over-the-counter products, should be clearly labeled."
But other physicians believe the overall risks of ephedra outweigh the benefits.
"There have been over 100 documented deaths associated with ephedra," said Barish, a UMMC emergency department physician. "Why would you even put yourself at risk? Nobody should take ephedra, and if you are taking it you should stop."
By Michelle W. Murray