Over-the-counter dietary supplements containing ephedra do more harm than good and should be removed from the market, according to the American Heart Association.
In comments submitted to the Food and Drug Administration (FDA) today, the American Heart Association supported the FDA proposal to limit the manufacturing and marketing of ephedra-based dietary supplements, but stated its own view that the dietary supplements containing ephedra, a potent stimulant used in many over-the-counter weight loss and body building products, should be banned. The Association also recommends that, in the meantime, consumers consult with their doctors before using products containing ephedra.
“Evidence continues to grow that the dangers posed by these dietary supplements far outweigh any potential benefit that they may have,” said American Heart Association President Robert O. Bonow, M.D. “Consumers who take these products may think they are doing something good for their health, but the truth is they may be putting themselves at serious risk.”
Supplements containing ephedra are often used to enhance athletic performance and to lose weight, but a recent RAND Institute study indicates that there is no evidence that these supplements actually improve athletic performance. In addition, there is not sufficient long-term evidence of the safety or efficacy of these products when used for weight loss. “The short- term studies that have shown slight decreases in weight were performed in controlled settings and cannot be used to predict safety and efficacy for the population at large,” Bonow explained.
The side-effects associated with these products are primarily cardiovascular-related. A review of FDA data on reported events indicates high blood pressure, stroke, heart attacks and death linked to ephedra use. The American Heart Association believes that these reported events are merely the tip of the iceberg.
“There is no such thing as a magic weight loss pill and anyone who takes these products looking for a quick fix is misleading themselves,” said Dr. Bonow. “Maintaining a healthy weight is good for the heart and for overall health, but being thin is not worth risking your life. There are healthy ways to achieve weight loss goals and anyone who is concerned with losing weight should consult their doctor to find out how they can do this without putting themselves at risk.”
The American Heart Association made it clear that its comments refer only to over-the-counter dietary supplements, not prescription drugs containing ephedrine nor over-the-counter “drugs” containing pseudo-ephedrine (such as many non-prescription cough and cold medicines). While these over-the-counter drugs are regulated by the FDA, there are relatively few standards or guidelines for the manufacture and marketing of dietary supplements. The lack of standards means that consumers can’t be sure how much ephedra these supplements actually contain and whether they contain other compounds with possible hazardous health effects.
Bonow concluded that a complete ban is needed to fully protect consumers from this dangerous product. “Unfortunately, experience tells us that there is a tendency for the public to ignore warning labels and dosage information. Because of the uncertainty surrounding these products, we believe it is necessary to completely eliminate the risk.”