Excerpted from ABC News, Monday, 17 April 2000.

Figuring Out Ephedra

Since Recent Deaths, the FDA Is Studying Dangers of Ephedra

Washington, Lauran Neergaard (AP) -- The 38-year-old California man gulped his usual two capsules of the herbal supplement ephedra with a cup of coffee, then went on his daily jog. Later that morning, he dropped dead from cardiac arrest.

And a 35-year-old apparently healthy ephedra user collapsed during aerobics class with a stroke.

Medical experts say cases like these show a clear risk from the herbal stimulant -- yet with millions of Americans taking the supplements but reports of possible side effects in the hundreds, just who’s at risk is a major question.

Do you need a checkup before popping the pills? Is taking ephedra with caffeine or while vigorously exercising the problem? Is it the dose?

The Food and Drug Administration is struggling to find the answer. Heeding industry protests, the agency just dramatically scaled back an attempt to regulate ephedra-containing dietary supplements. Now, armed with 273 new reports of problems like the aforementioned, the agency is grappling with whether the supplements at least need warning labels.

Inconsistent Doses

"It is a dilemma for FDA," said Dr. Neal Benowitz of the University of California, San Francisco, who studied the issue for the government.

Ephedra poses "serious risks to subsets of the population," Benowitz added. Until doctors spell that out more specifically, consumers must "know these are not totally benign substances. They’ve got drugs in them. They’ve got serious side effects."

Complicating the issue further, a University of Arkansas study to be published in next month’s American Journal of Health-System Pharmacy tested 20 different ephedra-containing supplements and found half contained very different ephedra doses than the bottles promised -- sometimes lots less, sometimes lots more.

Ephedra, also known by the Chinese name ma huang, is the herbal form of ephedrine, an amphetamine-like stimulant. Ephedrine is sold in a few FDA-regulated over-the-counter asthma medications.

But herbal ephedra is sold in 200 unregulated dietary supplements, for weight loss, building muscle or boosting energy, and occasionally in large doses as an "herbal high."

Ephedra manufacturers insist that overall, the herb is safe. After all, millions regularly use it without problem.

Yet in some people, ephedra is linked to anxiety, sleeplessness, migraines, high blood pressure, seizures, irregular heartbeats, heart attacks and strokes.

It first made headlines when an otherwise healthy 20-year-old college student died in 1996. Ultimately, the FDA cited 800 reports of side effects, including 44 deaths, and proposed federal regulations to, among other things, slash the legal dose.

The dietary supplements industry furiously opposed the rules, and Congress’ General Accounting Office said last year that while ephedra did seem risky to some people, the FDA’s crackdown was based on sloppy science. So the FDA backed off.

Now the fight’s back on: The FDA this month released 273 additional reports of side effects among ephedra users. Now the FDA wants warning labels; it plans a public hearing this summer.

What Consumers Should Know

Clearly, people with heart disease or high blood pressure are at risk from stimulants, including ephedra, Benowitz says. Other risk factors: kidney or thyroid disease, a history of seizures, or diabetes.

Warning labels could help such people, although Benowitz says the California jogger apparently didn’t realize he had seriously blocked arteries.

Six ephedra manufacturers who just formed the Ephedra Education Council concede some risk: Unlike most companies, they have begun using warning labels urging caution if consumers have such diseases.

Yet council spokesman Theodore Farber contends if ephedra were really dangerous, FDA-approved ephedrine for asthma would cause problems, too.

Benowitz responds that asthmatics can indeed suffer side effects, but that far more people take ephedra supplements, for far longer, without a doctor’s care.

And, he notes, some ephedra users with no obvious medical problems, like that aerobics-loving stroke victim, suffer reactions. Why? Nobody knows, but he has two suspicions: Many ephedra supplements also contain a cup of coffee’s worth of caffeine, another stimulant, so a few capsules a day really rev people up.

Excerpted from ABC News, Monday, 17 April 2000.