FDA issues warning on male sex supplements
November 03 2004 1:00 AM ET
The Food and Drug Administration on Tuesday warned consumers not to buy or use the male sex supplements Actra-Rx or Yilishen because the supplements contain an ingredient that could lower blood pressure to unsafe levels. The FDA also instructed employees to block imports of the supplements, calling them "dangerous and even life-threatening." Actra-Rx and Yilishen are promoted as erectile-dysfunction treatments that enhance male sexual performance. 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 the Journal of the American Medical Association. Viagra, produced by Pfizer, was approved by the FDA to treat erectile dysfunction.
According to "Sex, Lies, and Niagra," published in the February 4, 2004, issue of JAMA, chemical analysis 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. "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 contained 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 interact with certain prescription drugs and illicit substances that contain nitrates, significantly lowering blood pressure to unsafe levels. Men at risk include those with diabetes, high blood pressure, high cholesterol, or heart disease. Those individuals use medications that contain nitrates and often suffer erectile dysfunction. The FDA advised people who have taken Actra-Rx or Yilishen to stop using it and to consult a doctor regarding an alternate erectile dysfunction treatment. (AP)