FDA warns again on sexual enhancement supplements

Assorted pillsThe U.S. Food and Drug Administration is warning consumers about yet another sexually enhancing dietary supplement "contaminated" with a Viagra-like ingredient that can cause dangerously low blood pressure.

For the past several years, FDA investigations have found many "dietary supplements" promoting sexual vigor may be harmful to consumers because they're loaded with undisclosed ingredients.


The subject of the latest FDA warning, TimeOut Capsules, are also marketed online as a dietary supplement for sexual enhancement. The FDA says the 2,500 mg capsules are labeled as "100% natural," which may mislead consumers into believing the pills are harmless and pose no health risks.

An FDA analysis determined TimeOut Capsules contain hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can make the user dizzy or light-headed.

Consumers who bought TimeOut Capsules should stop using them immediately, the FDA warned, since sexual enhancement products that claim to work as well as prescription products may expose consumers to potential injury or death. The agency is not aware of any incidents involving TimeOut Capsules.

The FDA has been sounding alarm bells since 2004 about so-called dietary supplements laced with undisclosed prescription drugs or other potentially harmful ingredients. Since these "performance enhancers," like TimeOut Capsules, are usually marketed as all-natural alternatives to prescription drug products like Viagra, unsuspecting consumers are led to believe they're completely safe.

"The number of these problematic products available on the Internet appears to be increasing," says Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, in a statement. Recent actions by the FDA bear out his warning.

In mid-August, Glow Industries, Inc. of Perrysburg, Ohio, announced a voluntary nationwide recall of Mr. Magic Male Enhancer from Don Wands. The recall was prompted by an FDA lab analysis that found Mr. Magic Male Enhancer capsules contained active ingredients similar to those found in Viagra, making Mr. Magic an unapproved new drug. A week earlier, Prolatis' of Salt Lake City, UT also announced a voluntary nationwide recall of its dietary supplement Prolatis' for almost identical reasons.

In June, the FDA cautioned consumers about the dangers of Magic Power Coffee ("the world's first passion coffee") which was marketed an all natural dietary supplement, but also actually contained a Viagra-like ingredient.

And in April, Atlas Operations, Inc. of Pompano Beach, Fla., announced an expansion of its December 2009 voluntary nationwide recall of the company's dietary supplements for sexual enhancement to include Stamin It, Erectzia, and Vigor 100, all of which contain – you guessed it – a Viagra-like ingredient.

For more information, consult this list of dietary supplements to avoid from the FDA. The FDA also advises consumers who have experienced any negative side effects from any sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program or call 800-FDA-1088.

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