Related topics: •  Herbs & Supplements •  Special Report: Ephedra Supplements, Part 2 •  Sports Drinks

Editor's note: On Dec. 30, 2003, U.S. Health and Human Services Secretary Tommy G. Thompson announced that the government planned to ban the sale of pills containing ephedra in early 2004, and he urged consumers to stop taking the herbal stimulant immediately. The ban took effect on April 12, 2004. Several years of court battles followed, but ultimately the ban was left intact. Thompson's action to ban ephedra came after years of criticism from consumers and researchers who have documented cases of heart attacks, high blood pressure, and strokes associated with ephedra. While products like the sports drink Extreme Ripped Force no longer contain ephedra, some supplement manufacturers have replaced it with bitter orange, a substance that may carry the same risks as ephedra. Our award-winning, two-part series below published in 2000 was one of the early articles alerting readers to the dangers of ephedra.

Near the Gatorade and bottled water in the cooler at Gold's Gym in San Francisco, you can find American Body Building's sports drink, "Extreme Ripped Force." In this gym, as in a nearby 24-Hour Fitness center and other local sports clubs, these drinks rest in cup holders atop treadmills and StairMasters, and gym members sip them while reading the paper after their workout. Like many consumers across the country, they're using the supplements to drop pounds, increase their endurance during workouts, and to lift more weight. Some like it simply for the "buzz" and feeling of extra energy it provides.

Cathy*, a 27-year-old San Francisco woman, occasionally takes another sports supplement -- Twinlab Corporation's "Ripped Fuel" capsules -- for pep before going out at night. And for a little lift in her workout, she often takes a pill before visiting the gym. "I have looked at the ingredients but I can't say that I'm all that concerned about it. I don't even remember what's in it," she says. What she doesn't know is that the active ingredient in such pills and sports drinks -- ephedra -- has been linked by scientists to a host of serious medical problems, including stroke, heart attack, even death.

Ephedra, also known as ma huang, contains the active ingredient ephedrine, a stimulant found in over-the-counter and prescription medicines such as decongestants, bronchodilators, and allergy medications. Ephedra has recently sped to popularity as a key element in energy-boosting sports supplements and appetite-suppressing diet pills, many of them carried by national sports club chains. The stimulant is also found in many cheap "point-of-purchase" pep pills available at the cash registers of drugstores and convenience stores across the country.

But ephedra is not an innocent cup of coffee in a pill or trendy sports drink. The stimulant appears to be safe when taken in Chinese medicine or a decongestant as prescribed by a qualified medical practitioner such as a pharmacist, acupuncturist, or doctor, but it's another story when used as a sports supplement or diet pill.

Ephedrine, a chemical cousin of amphetamine, stimulates the central nervous system, increasing heart rate and blood pressure, sometimes to dangerous levels. People who regularly pop pills containing ephedra before a workout or to lose weight may be playing supplement roulette with their health, experts say. Besides heart attack and stroke, consumers may increase their risk of seizures, extreme nervousness, heart muscle damage, and irregular heartbeat -- particularly if they're predisposed to these conditions. The state of Nebraska, in fact, recently banned the use of dietary supplements containing ephedra, and Canada has also put restrictions on such products. The International Olympic Committee and National Collegiate Athletic Association have also prohibited the use of ephedra among athletes.

Fred Mayer, head of Pharmacists' Planning Service, has led an effort to restrict ephedra products in California, and believes combining ephedra and exercise is risky. "When you exercise, you raise your blood pressure and your heartbeat speeds up," he says. "And you're adding a product that makes your blood pressure soar." While millions of people have used these products without serious incident, any time someone predisposed to heart problems or hypertension dramatically raises his blood pressure, he may be putting himself at serious risk -- no matter what his age.

In a recent report for the U.S. Food and Drug Administration obtained by Consumer Health Interactive, researchers investigated 139 "adverse reaction reports" allegedly linked to ephedra supplements. Their conclusion: Nearly a third of the cases were "definitely or probably linked to the use of ephedrine." The researchers -- pharmacologists Neal Benowitz and Christine Haller of the University of California at San Francisco's Division of Clinical Pharmacology -- also found that another 31 percent may have been caused by products containing ephedra as well.

Among the cases in this study linked to ephedra were reports of chest pain, seizure, severely high blood pressure, five cardiac arrests (two of which led to death and three that caused permanent disability), two acute myocardial infarctions, and four strokes that resulted in permanent disability; overall, eight deaths were reported. In the case of four fatal heart attacks linked to one popular energy pill containing ephedra, the people who died were 15, 22, 38, and 43 years old.

All in all, circulatory or heart problems of some kind cropped up in 47 percent of the ephedra-related injuries examined in the FDA report.

Wes Siegner, Jr., legal counsel to the Ephedra Education Council, a trade group that represents ephedra manufacturers, says the group sees serious flaws in the study. In a strongly worded letter to the FDA, Siegner criticized the FDA for failing to compile certain data, such as consumption and background risk figures. The council has hired its own group of researchers to rebut the study, he says. "There's no question, in the view of our experts, that these events were caused by other natural circumstances that are found in the population -- for example, arteriosclerosis."

Manufacturers have argued that any adverse effects of ephedra supplements are due to users taking excessive doses, as a recent press release from a manufacturer attests. "These products typically aim their advertising at young people saying they can produce euphoria," says Dr. Randy Smith, medical director of Metabolife International, which produces dietary supplements containing ephedra. "It is our belief that such irresponsible claims may have resulted in incidents of intentional overdose and abuse, and that in turn led to reports of adverse health effects from taking ephedra."

While taking these products irresponsibly will certainly increase the chances of an adverse reaction, Benowitz and Haller say that even when used as directed, ephedra-containing sports-energy and weight-loss supplements "present a significant and unreasonable risk of injury."

The UCSF researchers also argue that the warning labels on ephedrine-containing supplements are inadequate. Ripped Force warns that the recommended dosage of ephedrine for a healthy adult is 100 milligrams in a 24-hour period, but in 1997, the FDA proposed to limit ephedra intake guidelines to no more than 24 milligrams in a day. (These guidelines have since been withdrawn.)

"We feel our products are safe when used as directed," says Luke Bucci, Ph.D and vice-president of research for Weider Nutrition International (which owns American Body Building, the maker of Ripped Force). "We rely on hardcore science."

Jim Swords, director of corporate communications for Twinlab, says Ripped Fuel bottles clearly warn consumers to seek the advice of a doctor. "As with anything you ingest, you need to follow label instructions. If you're not sure, talk with the doctor. That's general advice for anything," he says.

Unlike prescription and over-the-counter drugs, herbs and other dietary supplements don't have to be tested for safety. Many companies have labels warning pregnant or nursing women not to take the supplement; Metabolife recently expanded its label to caution people who have high blood pressure or a host of other medical problems to consult their doctor before taking ephedra supplements. Some energy pills and drinks, however, fail to warn about the possibility of stroke or heart attack.

Anne Marie Capati, a 37-year-old fashion designer in New York City, could likely have benefited from a label warning about the risk of stroke. Because she wanted to lose weight, a fitness coach urged her to take daily doses of an herbal supplement containing ephedrine. Although she suffered from high blood pressure, which raised her risk of stroke while taking ephedrine, Capati apparently wasn't alerted to the danger. On October 1, 1998, she suffered a massive cerebral hemorrhage and died.

"Actions [of ephedrine] are likely to be responsible for some of the accounts of sudden death," says Dr. Raymond L. Woosley, MD and PhD, professor and chairman at Georgetown University Medical Center's Department of Pharmacology. Like the UCSF researchers, Woosley evaluated the FDA's case reports on ephedra and came to similar conclusions. Ultimately, Woosley concluded that the risk-benefit ratio of taking ephedra supplements was "unacceptable."

Browse the vitamin aisle at Safeway, Inc. -- which operates 1,659 supermarkets in North America -- and you'll find an array of athletic and weight-loss aids with names like Ultra Ripped Capsules and Ripped to the Max. GNC, another national chain, carries multiple ephedra products, and even manufactures one of its own: "Pro-Ripped Ephedra," a product its maker staunchly defends. "GNC is confident that the ephedra products it sells are safe for use according to product labeling... and comply with existing industry national standards," according to a GNC spokeswoman.

On the same shelves you also find, inches away, bottles of shark cartilage pills and other controversial herbal supplements. The selection of ephedra supplements, the number of brands and the form (powder, drinks, pills, bars) is dizzying. And it's hard to believe that something so readily available, in many cases stocked alongside fruit juices and multivitamins, can be harmful.

Perhaps for these reasons, consumers tend to be trusting when it comes to products with a health-food label. A Consumer Health Interactive poll found that when going to buy herbal supplements, 19 percent of respondents "trust their friend's recommendations," while 27 percent "pick things up in the store and try them."

In fact, the hazards of some herbal supplements may be masked by their all-natural aura. Many ephedra supplements -- and the majority linked to adverse effects -- contain not just ephedra but one or more additional stimulants, usually caffeine (often listed in its seemingly more benign herbal forms: guarana and kola nut). What's alarming, according to Benowitz's and Haller's report, is that such combinations increase the risk of serious injury. "The likelihood is that the toxicity of ephedrine is considerably greater in combination with caffeine," they concluded.

In a cautionary article published in July 1999, the Tufts University Health &Nutrition Letter included ma huang (ephedra) and caffeine in a list of extremely hazardous drug-herb combinations. The authors wrote that "taking ephedra with other stimulants [such as caffeine or decongestants with stimulant ingredients such as phenylpropanolamine or pseudoephedrine] can increase risk of high blood pressure, nervousness, irregular heartbeat or even heart attack or stroke."

Perhaps nonchalant substance-popping plays the most unsettling role in the ephedra story. On a given day, an unwary consumer could take Sudafed (which contains the stimulant pseudoephedrine) for a lingering cold, drink multiple cups of coffee, down a ma huang supplement and sports drink, and work out (remember, exercise also raises blood pressure). Without really thinking about it, that person has a risky combination of stimulants racing through his system.

Another possible pitfall of taking ephedra on a regular basis: You might get hooked. While there's been little research on the possibility that ephedra is addictive, several studies suggest it may be. A 1998 study of 36 female athletes by Dr. Amanda Gruber, associate chief of substance abuse in the biological psychiatry laboratory the Harvard-affiliated McLean Hospital, found that even though most of them had experienced some adverse effects from taking the supplement, they continued to use it. Nearly one in five showed "frank ephedrine dependence," needing increased dosages to achieve the desired effects, experiencing withdrawal symptoms after discontinuing its use, and attempting many times -- unsuccessfully -- to stop taking ephedra, the study found. "When I think of dependence, I think of those who continue to use [a substance] despite adverse effects," Gruber says. "And that is what I found in those women athletes."

Robert*, a 28-year-old man from San Francisco, admitted to feeling "somewhat addicted" when he was taking Ripped Fuel daily. He likes the way the pills made him feel, he says, adding that it "almost seemed that without them I didn't feel 'normal.'" He also says that he needed more to achieve the same effects he had originally felt on a lower dosage. "The energy seemed to last for a longer time when I was first using it -- for the first few weeks. One or two [pills] would last an hour or more (for a workout), then this seemed reduced to 45 minutes. Muscles seemed to tire faster." 29-year-old Mitchell*, also from San Francisco, says, "Everyone I know takes it. I think a few of my friends are doing too much of it because they've built up a tolerance."

In this regard, the effects of ephedra are similar to that of amphetamine, or "speed," according to Paul Wellman of the psychology department at the University of Texas. "The similarity between ephedrine and amphetamine is more than just a superficial one -- there are similarities in structure and in the way they're absorbed.

"Ephedrine has action on dopamine neurons in the brain -- in general, drugs that do that tend to have addictive qualities," says Wellman. "The claim that some of the manufacturers' representatives make -- that there is no potential for abuse with ephedrine -- does not seem to be true."

Gruber echoes this sentiment. "Ephedrine dependence is really similar to amphetamine dependence: It's hard to distinguish between them," she says. "Anything that can happen with speed can happen with ephedrine. It's all a matter of dosage. The difference is that this is available, and people who wouldn't fall into the trap of illegal drug dependence might fall into ephedrine dependence -- because using it is legal."

Ephedra users may also experience the sudden mood swings and paranoia more often associated with amphetamine users. The reason: Many adverse reactions involve psychological effects similar to those found in amphetamine psychosis. Woosley's report cites 24 cases of "severe changes in behavior, especially development of aggressive or paranoid behavior." And in susceptible individuals, ephedra, like other stimulants, can precipitate mania, during which people often exhibit poor judgment or become psychotic, according to Gruber.

The most recent FDA report provides the strongest evidence to date against ephedra supplements, but the FDA has been warning consumers of their dangers for years. Why, then, do gyms, sports clubs, health food stores, and supermarkets continue to promote the product?

"People want energy before their workout," says Laurie Pott, who runs retail operations for Gold's Gym in San Francisco. Pott says she is aware of the serious problems linked to ephedra; she personally recommends people consume sports drinks without the stimulant, but says the ultimate decision is up to the consumer. 24-Hour Fitness did not return calls for comment.

Meanwhile, manufacturers are promoting ephedra breathlessly, often with language that would seem more appropriate to descriptions of street drugs. Consider American Body Building's description of Ripped Force on its Web site -- www.getbig.com -- championing its "buzz" and "ultimate high." It has also recently released "Speed Stack" (available at some 24-Hour Fitness clubs), whose description reads: "Sometimes you feel it. Sometimes you just need it. Sometimes, you feel... The Need for Speed!... Other companies dared us to come out with the most powerful performance thermogenic drink on the market."

Also striking about the product, considering its potential hazards, is the benign form in which it's marketed -- Speed Stack, for example, is a fruit punch beverage. Extreme Ripped Force is bottled in fruity varieties with bright orange and red packaging.

"American Body Building has traditionally marketed strictly to the hardcore bodybuilders -- that's who the primary users are," says Bucci. "They even demand higher potencies than we're willing to put out. We do pass all the advertisements by attorneys to make sure we're in compliance with regulations."

The nutritionalsupplements.com Web site is dedicated to posting consumer reviews of supplements and vitamins of all sorts. On its bulletin boards, ephedra is almost always among the top five most popular topics. Dozens of posts about the stimulant both extol and condemn its effects. But a disturbing trend is evident across the boards: Many of these users are very young and impressionable, and they seem more than convinced about the ephedra "high." Here's one example, from a 16-year-old male:

"I lift non stop the whole time and all the football players think I'm on steroids or something like that. I just tell them I'm on Ripped Fuel not Andro like all the rest of them. But by the time forth (sic) period is over, my 'high' or my energy goes away and at fifth period I'm all bummed out and too tired to do anything ... Oh yeah, and when I take it, no one should mess with me because when I'm pumped up, I will throw someone across the room if they try to mess with me."

Or, as Mitchell puts it, "If it doesn't have ma huang, it might as well just be Mountain Dew."

So where does this leave us? Due to the high risks inherent in stacked ephedra supplements, corporate dietitian Michael Darnley, M.S., R.D., recommends sticking to "exercise and diet, which have very few significant side effects other than time constraints." Gruber agrees that exercise and healthy eating are perfectly worthy alternatives to ephedra products.

But if you're determined to use ephedra, be sure to check with your doctor first and be very aware of any other substances you're also ingesting during any given day. If you're taking any drugs for heart trouble, such as digitalis, ephedra could disrupt your heart rhythms, experts say. Other drugs and supplements that might spell trouble when combined with ephedra include theophylline, caffeine, Oxytocin, certain diabetes therapy drugs, dexamethasone, urinary acidifiers and alkalizers, amitriptyline, and reserpine, according to the Natural Medicines Comprehensive Database, published by the medical organization Pharmacist's Letter, which is based in northern California. Some supplement makers have also warned against taking ephedra with any other product containing ephedrine, pseudoephedrine (such as Sudafed), or phenylpropanolamine (found in some diet pills and cough medications), or to consult your doctor first if you're taking MAO inhibitors or have taken them within the last two weeks.

"People think this stuff is safe because it's sold in health-food stores," says Mayer. "The problem is that we have absolutely no standards. And until we do, people are going to get hurt."

Part II: The Need for Better Regulation

-- Benj Vardigan is a senior editor for Consumer Health Interactive and the winner of an Outstanding Young Journalist award from the Northern California chapter of the Society of Professional Journalists.

•These names have been changed.

Further Resources

If you've experienced an adverse reaction of any sort, it's important to report it. You can call the Food and Drug Administration hotline at (888) 463-6332.

References

Last updated August 26, 2009
Copyright © 2000 Consumer Health Interactive

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