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FDA targets online 'natural' product for ED.

A significant amount of sildenafil, the active ingredient of the erectile dysfunction drug Viagra, has been detected in a dietary supplement that is promoted as a "100% natural" treatment for sexual enhancement for men, according to a Food and Drug Administration warning against using the product.

The FDA said that tests performed by the agency determined that the product, ActraRx, which is sometimes imported under the name Yilishen, contained prescription-strength sildenafil. A letter published in the Journal of the American Medical Association in February had reported that a chemical analysis of Actra-Rx capsules bought at a store and via the Internet contained an average of 55 mg of sildenafil per capsule analyzed (JAMA 2004;291:560-2). The recommended dose of sildenafil is 50 mg for most patients, taken about 1 hour before sexual activity, according to its label.

Actra-Rx, which is sold on Web sites and over the counter, is promoted as a natural treatment for erectile dysfunction.

The FDA advisory warns that an interaction between sildenafil and prescription drugs containing nitrates, or nitrates found in amyl nitrate or other illegal substances, could result in dangerous drops in blood pressure. The FDA has issued an import alert to FDA field personnel, to stop the importation of these two products.
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Title Annotation:Gynecology
Author:Mechcatie, Elizabeth
Publication:OB GYN News
Date:Dec 15, 2004
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