Warning label on ephedra proposed

FDA sets public hearings

weight-loss product tied to heart attack deaths

March 01, 2003|By Peter Schmuck | Peter Schmuck,SUN STAFF

FORT LAUDERDALE, Fla. - Manufacturers of products containing ephedra could be forced to warn consumers that the herbal weight-loss aid and stimulant might cause heart attacks, strokes and death.

The Food and Drug Administration announced in Washington yesterday that strongly worded warning labels could be on bottles of the popular capsules within a few months, pending public hearings.

The agency left open the possibility that it will seek greater restrictions on the over-the-counter supplement.

"Throughout America, there continue to be tragic incidents that link dietary supplements containing ephedra to serious health problems in consumers that use these products," said Health and Human Services Secretary Tommy G. Thompson.

"I don't know why anyone would take these products. Why take the risk?"

The timing of the announcement is no mystery. Ephedra and its active ingredient, ephedrine, have been under FDA scrutiny for years, but efforts to raise awareness of the potential dangers of the substance gained momentum when a Florida medical examiner concluded that ephedrine had played a role in the heatstroke death Feb. 17 of Orioles pitcher Steve Bechler.

Bechler is believed to have taken three capsules of ephedrine-based Xenadrine RFA-1 - one more than the maximum recommended dosage - before collapsing during a workout at the Orioles' spring training facility in Fort Lauderdale, Fla.

The FDA has accumulated more than 100 reports of deaths associated with ephedrine use, and yesterday it released the results of a Rand Corp. study that concluded that the substance has been responsible for some deaths.

Manufacturers insist that products containing ephedrine are safe if taken as directed, but those claims have been challenged successfully in court - and are losing credibility in the court of public opinion.

North Dakota's Democratic Sen. Byron L. Dorgan recently called for hearings to examine the use of ephedrine by athletes, and pressure is building for Major League Baseball to join the International Olympic Committee, the NCAA and many other sports federations in banning the use of ephedrine products.

Orioles owner Peter Angelos said he hopes those hearings create public pressure to place greater restrictions on the over-the-counter sale of potentially harmful supplements.

"Drugs of the potency of ephedrine should be controlled," Angelos said. "If they are going to be dispensed for a particular malady or condition, that should be the responsibility of a physician. They should not be available over the counter."

For the foreseeable future, however, opponents of ephedrine might have to settle for the new warning labels and the possibility of further FDA action.

"Thank God," said Pat Bechler, the mother of Steve Bechler. "At least it's a step in the right direction, and we're thankful for it. I just hope it doesn't stop there. They need to get the threat of it out of sports and society."

The Orioles have come out strongly in favor of an outright ban on products containing ephedra, but because it is considered an herbal supplement it is subject to relatively light federal regulation. The FDA can take it off the market only if it can prove that the substance poses a serious threat to public safety.

Despite more than 1,000 reports of adverse reactions in the past few years, that threshold apparently has yet to be met.

Instead, the FDA is hoping that consumers will take a closer look at the warning labels and heed the Rand Corp. study that discounts the weight-loss claims of supplement manufacturers.

"I think there ought to be as many guidelines as possible," said Orioles vice president of baseball operations Mike Flanagan. "The more information that's out there, the better, so I'm thrilled. This is dangerous stuff."

The FDA also warned 24 manufacturers that there is little evidence to support claims that ephedrine enhances athletic performance.

Cytodyne Technologies, the company that makes the product allegedly taken by Bechler on the day of his collapse, has stopped advertising the supplement on its Web site until the Broward County Medical Examiner's Office releases the toxicology report from the Bechler autopsy.

The company released a statement yesterday saying that it would have no further comment regarding ephedra and the FDA announcement.

The Orioles banned the use of ephedrine in their minor league system in the late 1990s, and Major League Baseball added it to the list of prohibited substances in its minor league drug policy this week.

Ephedrine remains legal at the major league level because any restrictions must be negotiated with the Major League Baseball Players Association.

Baseball Commissioner Bud Selig and union director Donald Fehr were traveling yesterday and unavailable for comment, but union and management officials are already believed to be discussing possible revisions in the sports drug policy.

Even in the wake of Bechler's death, Orioles players have expressed ambivalence about a possible ban. Several said they use ephedrine products to battle fatigue during the 162-game regular season.

No one, however, objects to getting more information on the potential dangers of the supplement.

"That's good for the consumer to know," said Orioles second baseman Jerry Hairston, who has acknowledged using ephedrine occasionally. "The more knowledge, the better."

The enhanced warning labels met with approval throughout the clubhouse, even if some players were skeptical about the ability of a label to alter behavior.

"I guess that's good," said Orioles first baseman David Segui. "Is it going to make a difference? Probably not.

"The bottom line is, people have got to be responsible for what they put in their bodies, whether they are athletes or not."

The Associated Press contributed to this article.

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