A 24-year-old had been taking Metabolife, a supplement containing the powerful herbal substance ephedra for about a month. She wanted to lose some weight before her fall wedding, but the day after she got her engagement ring on her finger, she awoke with numbness in the right side of her face. She arose, walked to the bathroom and collapsed in the shower. She had had a stroke, and she nearly died.

This woman is one of an unknown number of Americans who have suffered serious illness or death after taking products containing ephedra, a traditional Chinese asthma remedy marketed with almost no governmental oversight by scores of U.S. companies as an energy booster or as a way to lose weight.

The safety of ephedra, whose manufacturers boast that they sell 3 billion doses each year, has been a source of dispute for years between the industry and those who regard ephedra as a dangerous, unpredictable drug with potentially catastrophic side effects.

Last month, the FDA published new reports implicating ephedra in 134 cases of serious side effects nationwide. It is unclear, however, whether the FDA intends to launch a new attempt at rulemaking. A 1997 attempt to limit ephedra dosages foundered after industry and congressional investigators showed that the FDA used sloppy techniques in preparing earlier data on 685 reports of adverse reactions to ephedra, which included 39 deaths.

The 1997 proposal, all but withdrawn this year, would have limited ephedra intake to 8 milligrams per dose and 24 milligrams per day for a maximum period of one week. Metabolife -- like many other companies -- uses a standard of 25 milligrams per dose and 100 milligrams per day. Metabolife sets a 12-week limit on duration of treatment. A recent study of 20 ephedra products conducted by the University of Arkansas showed that more than half of the samples did not contain the amount of active ephedra claimed on the label.

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."

It first made headlines when an otherwise healthy 20-year-old college student died from ephedra 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. 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.

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.

Washington Post Reference