GNC pulls ephedra
Take a pill; shed excess pounds. Take a pill; run faster. Take a pill; lift heavier weights.
A panacea for dieters, athletes and bodybuilders⢠Think twice, say many experts, if the metabolism-boosting, fat-burning dietary supplement of choice contains ephedra -- an adrenaline-like stimulant which has been linked to heart attacks, strokes, seizures, even death.
"My feeling is that ephedra is really very dangerous," said Leslie Bonci, director of sports nutrition at the University of Pittsburgh Medical Center. "As far as I'm concerned, one death is too many. And now, we've had several deaths, and it's still out there. It's a definite health risk."
Not necessarily so, countered A. Wes Seigner, Jr., legal counsel and spokesman for the Ephedra Education Council. "We absolutely think if these products are used appropriately for weight loss, they are completely safe," he said, although he acknowledged "rapidly dwindling number of companies in the ephedra business."
General Nutrition Centers, the nation's largest specialty retailer of nutritional supplements, announced in May it would pull any remaining ephedra-based inventories from its shelves at the close of business today.
"We continue to believe ephedra is a safe and effective product," noted Stephanie Mangini, spokeswoman for the Pittsburgh-based company. "But, we're a retailer. And as a retailer, we have to pay close attention to what the customers want. Our decision was based on customer demand."
Some companies are unwilling to jump off the ephedra bandwagon.
Although Metabolife International, Inc. has recently introduced Metabolife Ephedra Free, it continues to market and "absolutely stand behind" ephedra-based Metabolife 356, said spokeswoman Jan Strode.
In Illinois, the first state to ban sales of ephedra, Metabolife and other ephedra manufacturers are the target of a class action lawsuit filed May 12 in federal court . New York state banned ephedra sales 11 days ago. Meanwhile, ephedra caplets are readily available in convenience stores, truck stops and other retail outlets throughout Pennsylvania.
What is ephedra, and why is it causing such controversy⢠Also known as ma huang, the desert-grown shrub has been used for centuries by Chinese herbalists as a remedy for asthma and other respiratory diseases. Its principal active alkaloid, ephedrine and the less-potent pseudoephedrine, is also found in a number of over-the-counter cold, allergy and asthma medications.
"Ephedra, ephedrine and pseudoephedrine basically mimic a cheap amphetamine, or cheap speed," said Dr. Robert Whipkey, director of emergency services for Westmoreland Health System, based in Greensburg. "Medically, they constrict the blood vessels ... in the lungs, which help you breathe easier, and in the nose, which helps with the decongestant process."
He warned, "This isn't a selective process. These agents globally constrict all the blood vessels, coronary arteries included," which may lead to a heart attack, especially in those with heart disease.
Bonci said ephedra-based dietary supplements increase heart rate, respiration rate and core body temperature, which can become a deadly "catalyst" during a strenuous workout.
She cited Baltimore Orioles pitcher Steve Bechler's Feb. 17 death from heatstroke. An autopsy report linked the 23-year-old's death to his use of Xenadrine RFA-1, an over-the-counter diet supplement containing ephedra.
"It's very hard to make it safe when your heart rate is already elevated, you're out there in the elements, and then you add the supplement -- which is going to do exactly the same things vigorous exercise does -- on top of it," Bonci emphasized.
Dr. Jorge Vasquez, medical director of Allegheny General Hospital's Center for Digestive Health, believes the risks also outweigh the benefits for those seeking to lose weight. "Some people do benefit, but the amount they lose is usually modest -- maybe five or 10 pounds," he said, adding, "Most people can take these pills and get away with it. But others cannot. How do you know?"
Quite simply, you don't, said Vasquez, who also heads a weight loss clinic at Forbes Regional Hospital's Lifestyle Center. "I have patients buying this stuff on the Internet. It's a major problem. There is no proper way to take it without risk. I'm in favor of a ban on all these things because there is just too much risk."
The U.S. Food and Drug Administration is on a fact-finding mission in search of answers. It has intensified scrutiny of ephedra-based supplements -- labeled as foods, rather than drugs , under the Dietary Supplement Health and Education Act of 1994. While the FDA does not review for safety and effectiveness before these products are marketed, the agency can prohibit sales if a supplement presents a "significant or unreasonable risk or injury."
"We are taking this issue very seriously," said an FDA spokeswoman, who requested anonymity.
She said the FDA is involved in a "series of actions" aimed at protecting Americans from any risks associated with ephedra as currently marketed. The agency is in the process of reviewing 14,000 public comments it received regarding a warning label requirement for all ephedra-based supplements.
The Ephedra Education Council wants the FDA to crack down on manufacturers making defective products. The FDA will accept comments until Aug. 11 on that issue.
The FDA's response was prompted, in part, by a 2001 study by Rand Corp. , an independent health policy research organization, who reviewed the existing science on ephedra at the request of the U.S. Secretary of Health and Human Services Tommy Thompson.
The study suggested a link between ephedra and "catastrophic events such as sudden death, heart attack or stroke." The think tank concluded ephedra, ephedrine, and ephedrine plus caffeine did promote "modest, short-term weight loss;" but found no evidence these substances enhance physical performance.
The National Football League, the National Collegiate Athletic Association and the International Olympic Committee have banned the substance. However, at the high school level, Bonci is seeing increased use among student athletes.
"For kids, it's not necessarily the weight loss. It's the high," she said. "They want to get all hyped up before the game. And with that comes a whole host of concerns, obviously. These kids may be exceeding what the dose is, or they may already be on other medications, including bronchodilators for asthma."
In many instances, with products carrying names like Ripped Fuel, young athletes are "clueless" about what it is they're buying, Bonci said.
"I often hear, 'I don't take that, I take this,'" she said. "And I'll say, 'Yeah, but that has ephedra in it.' And they'll say, 'Oh, I didn't know that.'"
Seigner maintains the marketing and sale of ephedra-based products to anyone under 18 is a "frustrating" issue.
"The ephedra industry has been clear all along that these products are not appropriate for kids," he said. "At the same time, there have been a number of companies out there that are marketing these products to kids, with names that are obviously street drug knock-off type names. Magic Mushrooms, Herbal Ecstasy, Yellow Jackets, Black Beauties. Take any kind of street drug name you can find, and some company has adopted that and sold ephedra using those names."
Whipkey, who has seen "ingestion-type" cases among students and bodybuilders, said the signs are unmistakable: agitation, combativeness, paranoia, high blood pressure, rapid heart rate, excessive sweating.
"With several colleges in the area, we'll see kids come in who are just wired out on something ... ma huang, ephedra, ephedrine, stuff like that," he said. "The bad thing is a lot of times they won't tell you what they took. They took it on purpose because they wanted to feel that way ... or they think if they bought it at (a drugstore), it's not the problem."
Dean Matanin, director of pharmacy at Latrobe Area Hospital, agrees. "The thing with herbs is that they're natural. And, people tend to think if something is natural, that means it's good for you. Well, that's simply not always the case. And, being natural, it's sometimes very difficult to get an accurate reading on the dosage," which can vary widely from product to product, he said. The FDA recommends no more than 8 milligrams of ephedrine alkaloids per serving; no more than 24 milligrams per day.
Because dietary supplements avoid the FDA's rigorous drugs testing standards, "Do you really know what you're buying?" asked John Foglia, pharmacy manager and system clinical director for Westmoreland Health System. "The worst part is that some of these nutritional materials aren't coming out of what I'd call a sterile environment of a pharmaceutical company. Somebody out in California could be making these supplements in his garage, calling them 'Dr. Jones' Super Element of Life.' I'm not saying they're all that way. They certainly aren't. But how do you know⢠You don't."
Ephedra
Label ingredients indicating ephedra compounds:
Ingredients containing other stimulants, such as caffeine:
Popular ephedrine products:
Metabolife 356
Ripped Fuel
Diet Fuel
Stacker 3
NaturalTRIM
Xenadrine RFA-1
Up Your Gas
Truckers Luv It
Yellow Jackets
According to the American Medical Association, possible adverse reactions associated with the use of ephedra include fatal arrhythmias, nervousness, anxiety, fear, agitation or restlessness, weakness, irritability, talkativeness, insomnia, dizziness or lightheadedness, tremors, heart palpitations, sinus tachycardia or fast heart rate.
Those who should avoid ephedra-based dietary supplements and/or over-the-counter medications containing pseudoephedrine:
