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Voluntary Withdrawal of an Alternative-Medicine Product

Johns Hopkins University
By Simeon Margolis, M.D., Ph.D. - Posted on Wed, Jun 03, 2009, 12:50 pm PDT

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The California company Bodee LLC recently announced a "voluntary" recall of all its products promoted under the names of Zencore and Zencore Plus, which the company claimed were cures for erectile dysfunction (ED). The complete line of Zencore products had been sold in health food stores nationwide and by email over the Internet.

The recall was made when the Food and Drug Administration (FDA) determined that the Zencore products contain benzamidenafil, a substance that blocks the action of the same enzyme (type 5 phosphodiesterase) responsible for the beneficial effects of the FDA-approved drugs for erectile dysfunction (ED)—sildenafil (Viagra®), tadalafil (Cialis®), and vardenafil (Levitra®).

The danger of Zencore is that it, like the approved drugs for ED, can cause a severe, life-threatening drop in blood pressure when used by men who are also taking a nitrate to relieve the angina that is caused by coronary heart disease. People who get the approved drugs for ED from their doctors are warned of this potentially fatal side effect as well as other possible troublesome effects, but those who buy Zencore over the Internet had no way of knowing that Zencore harbors those same dangers.

A Web site for Bodee LLC states that Zencore is a "natural" herbal supplement that enhances male sexual function and improves a man's capacity for having an erection. Ironically, the advertizing on their Web site also suggests using Zencore if "you are worried about the adverse effects of prescription drugs" for ED. Their withdrawal notice further states that they are "committed and always concerned with the health of persons who have consumed this product."

This concern is belied by the fact that Encore, another one of Bodee LLC's ED products, was "voluntarily" withdrawn 16 months ago when the FDA discovered that the product contained aminotadala, a chemical similar to the tadalafil in Cialis tablets.

Do you believe this company would have "voluntarily" withdrawn either of these money-making supplements if the FDA had not discovered that they contained drug-like substances that can present real dangers?

Promoters of dietary supplements like Zencore and Encore frequently tout their products with testimonials from satisfied users. But a supplement is of course going to work if it contains a substance proven to work in a prescription drug.

These ads also generally claim that their products are "natural," a term that many people mistakenly take to mean "safe." (Many consumers also believe the product really is natural, even though so many dietary supplements have been shown to be adulterated with prescription drugs.)

I was unable to find other supplements sold by this company on the Internet, but I would certainly advise using great caution before buying any other products it might be selling.

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