WASHINGTON – The Food and Drug Administration on Tuesday warned consumers not to buy or use Actra-Rx or Yilishen because the supplements contain an ingredient that could lower blood pressure to unsafe levels.
Actra-Rx and Yilishen are promoted on Web sites as erectile dysfunction treatments that enhance men’s sexual performance, the FDA said.
The FDA also instructed employees to block imports of the supplements, calling them “dangerous … and even life-threatening.” The agency said the supplement bears the name Yilishen when it is imported from China and is sold as Actra-Rx within the United States.
Laura Alvey, an FDA spokeswoman, declined further comment saying the matter is under investigation that may lead to criminal or civil enforcement actions.
When the FDA in March 27, 1998, approved Viagra, the first pill to treat impotence, it warned consumers not to use the drug in combination with products containing nitrates to avoid worrisome lowering of blood pressure.
Because people buy Actra-Rx without a doctor’s prescription, however, consumers receive no such warning.
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.
According to “Sex, Lies and Niagra,” published in the Feb. 4, 2004, issue of JAMA, chemical analyses 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.
Followup testing by the FDA confirmed Actra-Rx contained prescription-strength levels of sildenafil.
The recommended dose for Viagra, produced by Pfizer, is 50 milligrams. Some men take as little as 25 mg. or as much as 100 mg.
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