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FDA warns consumers of sexual enhancement 'dietary supplement'  dangers       Send a link to a friend

[NOV. 6, 2004]  The Food and Drug Administration warns consumers not to purchase or to consume Actra-Rx or Yilishen, two products promoted and offered for sale on the Web as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance for men. These products in fact contain an active prescription drug ingredient. FDA has also issued an alert instructing FDA field personnel to stop the importation of Actra-Rx and Yilishen.

A research letter published in the Journal of the American Medical Association described the results of a chemical analysis of Actra-Rx, finding that each capsule analyzed contained prescription-strength quantities of sildenafil. Sildenafil is the active drug ingredient in Viagra, a Pfizer prescription drug product approved in the United States for the treatment of erectile dysfunction. FDA conducted its own tests of Actra-Rx and found that the product contained prescription-strength sildenafil.

An interaction between sildenafil and certain prescription drugs containing nitrates (such as nitroglycerin) or nitrates found in illicit substances (such as amyl nitrate) may cause a significant lowering of blood pressure to an unsafe level. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

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Because erectile dysfunction can be a common problem in individuals with these conditions, these consumers may take Actra-Rx or Yilishen and risk experiencing serious adverse effects. Anyone experiencing erectile dysfunction should seek guidance from their health care provider before purchasing a product to treat that condition.

Consumers who have taken Actra-Rx or Yilishen should stop taking it and consult with their health care providers regarding erectile dysfunction treatment. Consumers who are seeking treatment for erectile dysfunction should not take Actra-Rx or Yilishen, as either can be dangerous to their health and even life-threatening.

Consumer inquiries: (888) INFO-FDA

[U.S. Food and Drug Administration news release]

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