Another Dangerous Herbal ‘Supplement’ Ephedra

A controversy has developed over the safety of ephedra, an herb whose use began more than 5,000 years ago in China as a treatment for asthma. Today, millions of people have taken ephedra-based products as a dietary product to increase energy, lose weight, improve concentration and sharpen muscle tone. More than 200 health food products — such as diet bars, pills, drinks and powders — contain ephedra.

Critics of the use of ephedra as a dietary supplement point to the fact that the “active ingredient” of this herb from Asia is ephedrine, a stimulant similar in action to amphetamine. The Food and Drug Administration (FDA) reported that ephedrine-based supplements could produce irregular or rapid heartbeat, increased anxiety, insomnia, blood pressure, tremor and hyperactivity. Clinically serious effects of ephedrine supplements have been linked to seizure, psychosis, stroke, heart attack, and death.

During the past few years a number of deaths and numerous reports of adverse reactions have thrown ephedra-based dietary supplements into the spotlight. In one case, a woman in an apparent state of psychosis after taking an ephedra product for five days killed two teen-aged girls in a car crash. In the second case, a 37-year-old woman with high blood pressure died after suffering a stroke at a fitness club after taking an ephedra product for five days. Attributing her death to ephedra, her husband has filed suit against the manufacturer of the product.

Joseph A. Levitt, director of the Center for Food Safety and Applied Nutrition of the FDA recently reported that dietary supplements provoked about 1,600 adverse health reports between 1993 and mid-1996. The number of reported effects that were traced to ephedrine-based products totaled about 800. The FDA emphasized that these adverse effects were not only evident in people with pre-existing aliments or diseases, but also in healthy individuals. Of great concern was the fact that many of the adverse effects occurred in young adults who would not be expected to be at high risk for heart attack or stroke. For example, medical examiners attributed the deaths of two young men taking ephedra-based supplements to ephedrine toxicity.

Unlike prescription drugs without a prescription, which must get FDA approval before they are marketed to the public, dietary supplements must be proven unsafe before the FDA can restrict the use of a product. As part of FDA’s regulation of these products, the agency requested comment on the reported effects of ephedrine-based dietary supplements. The General Accounting Office (GAO) responded by concluding that there was not enough solid evidence to support restrictions on ephedrine-based supplements. This action by the GAO has effectively delayed resolution of the many questions surrounding ephedrine-based supplements.

Joining the public debate, Michael Ellis, chief executive of Metabolife International Inc., manufacturer of ephedra-based dietary supplements, has recently spoken out on the safety of herbal products. Mr. Ellis urges the FDA to appoint a working group to look into the use of ephedra-based products and other herbs. With ephedra-based products literally flying off the selves, this recommendation is timely indeed.

In addition, the establishment of an FDA working group on herbal products has the potential for far greater importance. The United States FDA no longer has the regulatory authority to judge the safety, effectiveness and potency of herbal products marketed as dietary supplements. Such substances were removed from FDA oversight by the 1994 Dietary Supplement Health Education Act, promoted and financed by the supplement industry. Poor quality, adulteration and contamination of herbal supplements are also potential problems because there are no standards applied to their harvesting, processing or packaging.

“All so-called dietary supplements, particularly those that are herb-based, should fall squarely within the purview of the FDA,” says ACSH’s publications director Jack Raso, a longtime critic of alternative medicine. “With herbal supplements especially, the potential for harm exceeds the potential for appreciable health improvement.”

Until a detailed review of guidelines for herbal dietary supplements is completed, consumers and their doctors must weigh their possible benefits against their potential risks.

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