- The Washington Times - Saturday, March 1, 2003

Ephedra, an herbal stimulant commonly used by athletes for weight loss and bodybuilding, can kill and its label should include a strong warning of potential risks, such as heart attacks and strokes, federal health officials said yesterday.
The officials proposed new warning labels after releasing an independent study that links ephedra to several deaths and says the amphetaminelike stimulant offers very little help with weight loss. The dietary supplement industry has successfully blocked the labels since 1997.
The new label could be on every bottle by year's end, the first in a series of Food and Drug Administration steps that could limit if not stop use of the herb that is sold over the counter.
"Throughout America, there continue to be tragic incidents that link dietary supplements containing ephedra to serious health problems in consumers using those products," Health and Human Services Secretary Tommy G. Thompson said at a news conference yesterday.
U.S. Food and Drug Commissioner Mark McClellan said current scientific evidence strongly suggests that at least some ephedra products present an unreasonable risk.
Mr. Thompson and Mr. McClellan made their comments four days after Major League Baseball banned the use of ephedra within the minor leagues and 11 days after Baltimore Orioles pitcher Steve Bechler, who had been taking ephedra, died of a heatstroke at the team's spring training complex in Fort Lauderdale, Fla.
Medical examiners in Broward County, Fla., who did an autopsy on Bechler, 23, have identified dietary supplements containing ephedra as a key factor in the pitcher's death.
The medical examiners said other factors could have been instrumental in Bechler's death, such as he was overweight, had an enlarged heart, had borderline hypertension, or high blood pressure, and was diagnosed two years ago with an abnormal liver.
Leaders of the dietary supplement industry contend ephedra is safe if taken in proper doses. But an independent study by the Rand Corp., which federal officials cited yesterday, concluded ephedra probably has killed at least occasionally.
According to the FDA, products with ephedra have been linked to at least 100 deaths and 1,500 reports of medical problems, including heart attacks, strokes and seizures.
Last year U.S. consumers spent $1.3 billion on ephedra products, which they purchased to lose weight and boost energy.
The FDA said yesterday it has warned 24 firms that sell ephedra, primarily marketing to athletes, that it has no proof ephedra aids athletic performance. The warnings signal that the government is contemplating a bigger crackdown on the herb, such as a ban.
Sen. Richard J. Durbin, Illinois Democrat, who for six months has been calling for ephedra to be banned, said it's important that people know it's a "worthless product."
But he said it's more important that they know it can be harmful and that it not be available for purchase.
Ephedra can be sold over the counter because it's an herb. To curb or halt sales, the FDA must prove it's a clear and present danger to the public health.
The FDA has long had concerns about ephedra, which stimulates the central nervous system and may elevate heart rate and blood pressure.
The agency says those effects can be worsened by exercise and use of other stimulants, such as caffeine.
In 1997, manufacturers of dietary supplements thwarted FDA efforts to restrict sales of certain doses of ephedra and impose strong warning labels.
Yesterday, the FDA reopened for public comment the warning label first proposed five years ago. Public comment is required before the FDA can require warning labels.
The proposal suggests that every bottle containing ephedra list death, heart attacks and strokes as potential side effects.
"Warning labels are good, but they don't do enough," said Mr. Durbin, adding he firmly believes the FDA has enough evidence to ban ephedra.
The FDA also said its review of 140 "adverse-event" reports associated with supplements containing ephedra concluded that nearly a third of them were definitely or probably linked to ephedra use.
The agency said adverse effects include rapid heartbeat, difficulty urinating, headaches, nausea and vomiting. High doses of ephedrine the primary active ingredient in ephedra may sharply raise blood pressure and produce cardiac arrhythmia, the medical term for an irregular heartbeat.
This story is based in part on wire service reports.

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