- The Washington Times - Thursday, March 11, 2004

The U.S. Food and Drug Administration yesterday ordered 23 drug manufacturers to stop selling androstenedione, the steroidlike dietary supplement made famous by major league home-run slugger Mark McGwire, citing health risks.

The product in question, commonly known as ‘andro,’ is classified as a precursor to an anabolic steroid — something the body uses to produce testosterone and build muscle. When ingested, andro metabolizes into a steroid, which is a controlled substance, top federal health officials said at a news conference where they announced their action.

“The body turns a steroid precursor into a steroid, posing the same health risks as other steroids,” Health and Human Services Secretary Tommy G. Thompson told reporters.

Food and Drug Administration (FDA) Commissioner Mark McClellan put it this way: “Anyone who takes these products in sufficient quantities to build muscle or improve performance is putting himself or herself at risk for serious long-term and potentially irreversible health consequences.”

Medical studies show andro raises testosterone levels beyond normal levels. Medical conditions associated with its use included heart disease, liver and kidney dysfunction or failure; severe acne and hair loss; internal bleeding; and reduced sperm count among men.

Health officials at the news conference said steroids are especially dangerous when used by children and teenagers going through puberty. Youngsters at that age can experience a halt in growth because the steroids cause development in long bones to shut down forever.

Andro became popular when McGwire acknowledged using it in 1998, the year he hit 70 home runs for the St. Louis Cardinals, breaking the record of the late Roger Maris of the New York Yankees. Professional baseball allowed use of andro at that time, though most other sports did not.

McGwire, who retired from baseball in 2001, says he no longer takes the supplement,

Mr. McClellan, Mr. Thompson and other FDA officials made their case for keeping andro off the market both at the news conference in Washington and in warning letters sent to companies that make the product,

Asked what will happen if any firms continue to market andro, Mr. McClellan said, “We hope the companies will promptly remove [products containing andro], as they have given us no evidence they are safe.”

If they refuse to comply, Mr. Thompson said, the companies will be subject to product seizures, injunctions and criminal actions.

The FDA’s crackdown on andro comes on the eve of a pending April 15 ban on products containing the herbal stimulant ephedra, used for weight loss.

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