Non-prescription drugs often cause major damage

Posted: Tuesday, March 04, 2003

The heatstroke death of a Baltimore Orioles pitcher has again focused attention on the dangers of ephedra as a weight-loss aid. But this country's nonprescription drug problem is much larger than one risky diet pill.

Americans use two kinds of drugs to fight disease and promote health. One type, available by prescription or over the pharmacy counter, must pass scientific muster for safety and effectiveness. The other, sold at nutrition stores or by mail, gets no independent review.

Ephedra is an example of both. In synthetic or concentrated form, and offered as the cold medication ephedrine, it must be approved by the U.S. Food and Drug Administration. Purchasers have FDA's assurance that the product is pure, safe and reasonably effective.

But in ''natural'' form, ephedra compounds can be made and sold without any independent testing whatever -- as long as makers limit the health claims they put on their labels. Of course they find other routes, like magazine articles and retail sales pitches, for making the prohibited claims.

Thus millions of Americans know ephedra as a fat burner, a workout booster, a study aid and a recreational ''legal speed.'' Some may expect that ephedra products have been tested to assure that they perform as advertised. More, probably, conclude that if a drug is available without prescription, it's got to be safe. ...

FDA is a passive recipient of these danger signals; it doesn't require supplement companies to turn over the complaints they receive. Ephedra has been the subject of some 1,400 complaints to FDA in recent years, more than 50 of which implicate it as a cause of death. Later this spring the agency will probably start proceedings to ban it. ...

Full-fledged regulation of all vitamins, herbs and supplements by FDA is neither realistic nor necessary. This means self-prescribing consumers will still be on their own to guard against overuse, overdose and drug interactions. ...

-- Star Tribune, Minneapolis

Feb. 24

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