FDA Cautions on Supplement
The Food and Drug Administration warned consumers Tuesday not to buy or use the supplements Actra-Rx or Yilishen because they contained 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.” The agency said the supplement had the name Yilishen when it was imported from China and was sold as Actra-Rx in the U.S.
Actra-Rx and Yilishen are promoted on websites as erectile dysfunction treatments that enhance men’s sexual performance, the FDA said.
Laura Alvey, an FDA spokeswoman, declined to comment further, saying the matter was under investigation that may lead to criminal or civil enforcement actions.
In March 1998, when the FDA 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 ingredient in Viagra, according to a letter in the Journal of the American Medical Assn. “Sex, Lies and Niagra,” published in the Feb. 4, 2004, issue of the JAMA, said 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 had been sold.
“The use of such nonprescription substances may present health risks for individuals with contraindications to the use of sildenafil,” the authors wrote.
Follow-up 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 milligrams or as much as 100 milligrams. Last year, Viagra cornered 90% of the market for drugs treating erectile dysfunction with sales of $1.14 billion. In the first seven months of 2004, its market share eroded to 76.5% and sales totaled $597 million, according to IMS Health statistics.
A spokesman for Los Angeles-based Body Basics declined to comment. The company’s voicemail identifies it as manufacturer of Actra-Rx. The company’s website continues to advertise Actra-Rx as a “natural sexual enhancer” available in starter kits of 10 pills for $78.99.
In June 2003, Pfizer filed a trademark infringement suit against Body Basics, which had been using the name Niagra to sell the supplement. The federal court, in a consent judgment, barred the company from using that name, said Bryant Haskins, director of corporate media relations at Pfizer.
The FDA says the sildenafil in Actra-Rx can interact with prescription drugs that contain nitrates or nitrates in illicit substances, 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 had taken Actra-Rx or Yilishen to stop using it and consult a doctor for an alternate treatment.
