FDA Is Investigating the Use of Ephedra

Food and Drug Administration investigators are looking into the death of Baltimore Oriole pitcher Steve Bechler as they try to decide how dangerous the herbal stimulant ephedra might be and whether to ban it, the FDA’s chief said Wednesday.

Ephedra may prove particularly risky for athletes, and settling the long-simmering controversy about the herb’s safety is a high priority, FDA Commissioner Mark McClellan said in an interview with Associated Press.

Ephedra, an herb commonly used for weight loss and body building, increases metabolic rate and speeds the heart, he said. Add strenuous activity, and “sports use is one area where I have got some particular concerns,” McClellan said.

McClellan’s boss, Health and Human Services Secretary Tommy Thompson, convened a meeting of health officials to discuss ephedra late Wednesday. Asked what he thought of the herb, Thompson told reporters: “I wouldn’t use it, would you?”

The comments came after a Florida medical examiner said Monday’s heatstroke death of Bechler may have been linked to an ephedra-containing supplement found in the 23-year-old pitcher’s locker at the Orioles’ spring-training camp.

Toxicology tests to prove if ephedrine, the herb’s active ingredient, was in Bechler’s body won’t be available for two weeks. But Broward County medical examiner Joshua Perper, who interviewed the player’s family and Oriole officials, said he was told Bechler took three pills of Xenadrine RFA-1 every morning.

Perper urged baseball officials to ban use of the supplement, as the NFL, NCAA and International Olympic Committee have.

Xenadrine’s maker, Cytodine Technologies, said in a statement that two capsules a day is the recommended dose, and that studies show the product is safe when used as directed.

But ephedra has long been linked to heart attacks, strokes and other serious side effects -- even at recommended doses, particularly if users have underlying heart trouble or certain other ailments. The FDA has reports of at least 100 deaths linked to use of the herbal supplements. A study published earlier this month found U.S. poison control centers reported 1,178 side effects among ephedra users last year, and critics have urged the FDA to ban the pills.

Now Bechler’s death is focusing attention on ephedra again.

U.S. Rep. John Sweeney (R.-N.Y.) said Wednesday that ephedra is too dangerous for athletes, adding he is sending a letter to the FDA asking to halt sales of ephedra products until Congress holds hearings on the issue.

Sweeney also wants Congress to end over-the-counter sales of products containing ephedra.

Meanwhile, Rep. Henry Waxman (D-Los Angeles) said in a letter to baseball Commissioner Bud Selig: “Despite [the] voluminous evidence pointing to the dangers of ephedra-containing dietary supplements, their use is still permitted in Major League Baseball. I would like to know why this serious safety issue has not been addressed.”

Waxman’s letter asks Selig for a response by March 1.

Baseball officials have said they will wait to make a decision about the substance until more is known about the circumstances of Bechler’s death.

Within a month, the FDA expects to receive a review of ephedra’s risks from the Rand Corp., hired to take an independent look at the controversy.

“We are going to get the reports, look at all this evidence and take appropriate action quickly,” McClellan said.

Because ephedra is an herb, federal law lets it sell over-the-counter with little oversight. Only if the FDA proves a danger to public health can it curb sales; manufacturers blocked an FDA attempt to restrict sales four years ago by arguing the agency didn’t have enough proof.

The Ephedra Education Council, an industry funded group, did not return calls seeking comment.