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FDA issues warning on risky sexual supplements

Saturday, June 21, 2003

WASHINGTON -- Consumers should not use any of six "sexual stimulants" sold in the guise of dietary supplements because they contain a prescription drug illegal to sell here and risky to some people, the Food and Drug Administration warned Friday.

The products sell under the names Sigra, Stamina Rx, Stamina Rx for Women, Y-Y, Spontane ES and Uroprin.

Internet advertising for the products claim they are all-natural products that increase stamina and sexual performance. But the FDA says testing shows they contain a prescription drug sold in Europe to treat impotence, Eli Lilly & Co.'s Cialis.

Cialis and its active ingredient, tadalafil, are not yet FDA approved to sell in this country. In addition, it is illegal to sell a prescription drug in the guise of a dietary supplement.

Further, the ingredient can cause a dangerous side effect in people who take nitrate-containing drugs to treat heart disease -- a common cause of sexual problems, the FDA warned.

FDA said its investigators recently searched facilities of the supplements' manufacturer, NVE Inc. in Newton, N.J., and its distributor, Hi-Tech Pharmaceuticals of Norcross, Ga. The FDA said it is working to pull the products off the market but considered the risk serious enough to issue a consumer warning.

The companies could not be reached for comment Friday.

FDA officials refused to say what prompted them to investigate the products but did say they have no reports of consumer injuries.

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