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FDA Warns of Actra-Rx and Yilishen Male Enhancement Products

WASHINGTON

The Food and Drug Administration on Tuesday warned buyers not to purchase or use Actra-Rx or Yilishen since the supplements include a component that could lower blood pressure to hazardous levels.

The FDA also instructed employees to block imports of the supplements, calling them "dangerous ... and even life-threatening."

Actra-Rx and Yilishen are endorsed as erectile dysfunction treatments that improve men's sexual performance.

In spite of an all-natural label, Actra-Rx capsules enclose prescription strength levels of sildenafil, the active drug element in Viagra, according to a letter published in the Journal of the American Medical Association.

Viagra, produced by Pfizer, was approved by the FDA to cure erectile dysfunction.

In accordance with "Sex, Lies and Niagra," published in the Feb. 4, 2004 issue of JAMA, chemical analysis found a typical of 55 milligrams of sildenafil per capsule of Actra-Rx and Niagra Actra-Rx, one more name under which the product has been sold.

"The use of such nonprescription substances may present health risks for individuals with contraindications to the use of sildenafil," wrote the authors.

Follow up testing by the FDA confirmed Actra-Rx enclosed prescription-strength levels of sildenafil.

A spokesman for the supplement's manufacturer, Los Angeles-based Body Basics, declined comment.

According to the FDA, sildenafil can interrelate with some prescription drugs that include nitrates or nitrates in illicit substances, considerably lowering blood pressure to unsafe levels.

Men at risk are those with diabetes, high blood pressure, high cholesterol or heart disease. Those persons use medications that contain nitrates and frequently suffer erectile dysfunction.

The FDA advised people who have taken Actra-Rx or Yilishen to stop using it and to talk to a doctor regarding an alternate erectile dysfunction treatment.

Visit FDA Official Site: http://www.fda.gov/

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