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>F.D.A. Warns of Supplements Containing Viagra >Ingredient >By THE ASSOCIATED PRESS > >Published: November 3, 2004 > > >ASHINGTON, Nov. 2 (AP) - The Food and Drug >Administration warned consumers on Tuesday not to buy >or use nonprescription supplements known as Actra-Rx >or Yilishen because they contain the active ingredient >in the prescription drug Viagra and could lower blood >pressure to unsafe levels. > > Advertisement > > >The agency also instructed employees to block imports >of the supplements, which are advertised on Web sites >as treatments for erectile dysfunction, calling them >"dangerous and even life-threatening." The agency said >the supplement bears the name Yilishen when it is >imported from China and is sold as Actra-Rx in the >United States. > >Laura Alvey, an F.D.A. spokeswoman, said the matter >was under an investigation that could lead to criminal >or civil enforcement actions. > >In 1998, when the agency approved Viagra, the first >pill to treat impotence, it warned consumers not to >use the drug in combination with products containing >nitrates to avoid lowering blood pressure. > >Because people buy Actra-Rx without a doctor's >prescription, however, consumers receive no such >warning. > >Despite an all-natural label, Actra-Rx capsules >contain prescription strength levels of sildenafil, >the active drug ingredient in Viagra, according to a >letter published in February issue of The Journal of >the American Medical Association. The letter said that >chemical analyses found an average of 55 milligrams of >sildenafil per capsule of Actra-Rx and Niagra >Actra-Rx, another name under which the product has >been sold. > >Follow-up testing by the federal agency confirmed that >Actra-Rx contained prescription-strength levels of >sildenafil. The recommended dose for Viagra, produced >by Pfizer, is 50 milligrams. Some men take as little >as 25 milligrams or as much as 100 milligrams. > >Body Basics, a Los Angeles-based company, is >identified in a corporate voice-mail message as the >manufacturer of Actra-Rx, but a spokesman declined to >comment on Tuesday. The company's Web site advertises >Actra-Rx as a "natural sexual enhancer" available in >starter kits of 10 pills for $78.99. > >According to the F.D.A., the sildenafil in Actra-Rx >can interact with certain prescription drugs that >contain nitrates or nitrates in illicit substances, >lowering blood pressure to unsafe levels. > >Men at risk include those with diabetes, high blood >pressure, high cholesterol or heart disease.

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