| U.S. Food and Drug Administration |
FDA Statement, Nov 2, 2004
FDA Warns Consumers That Actra-RX "Dietary Supplements" Promoted For Sexual Enhancement Contains Undeclared Prescription Drug Ingredient
The Food and Drug Administration today warned consumers not to purchase or to
consume Actra-Rx or Yilishen, two products promoted and offered for sale on Web
sites 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 Import 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.
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.
This advisory was prepared by the FDA Office of Public Affairs.