Dr. Charles Runels, MD
On July 12, 2006, the US Food and
Drug Administration (FDA) warned consumers not to purchase or consume Zimaxx,
Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are
sold on Web sites as "dietary supplements" that serve as erection enhancers and
for enhancing sexual performance, but they are in fact illegal drugs that
contain potentially harmful undeclared ingredients. These products have not been
approved by the FDA, and there is no guarantee of their safety and
effectiveness, nor of the purity of their ingredients.
The FDA advises consumers who have used any of these products to discontinue use and to consult a health care provider. The agency encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat erection problems.
Chemical analysis by the FDA revealed
that Zimaxx contains sildenafil, which is the active pharmaceutical ingredient
in Viagra. The other products contain chemical ingredients that are analogs of
either sildenafil or vardenafil, the active ingredient in Levitra. There is no
mention of any of these ingredients in any of the illegal products' labeling.
These products pose a threat because the undeclared ingredients may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels (they can kill you). Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile dysfunction is a common problem in men with these conditions, and these patients may seek products like the ones noted above because these products claim that they are "all natural" or that they do not contain the active ingredients used in FDA-approved ED drugs. In addition, because the manufacturing source of the active ingredients in these "dietary supplements" is unknown, there is no assurance that the ingredients are safe, effective, or pure.
In summary, when you buy these
"supplements" what you're really buying is a watered down version of Viagra or
Levitra from an unknown source that may not be even clean enough to package
FDA warning letters to the firms marketing these products state that the products are illegal drugs based on claims made for the products or their ingredients. The letters also state that the products' labeling is false and misleading because it fails to disclose the presence of the chemical ingredients or the potential adverse effects associated with the products' consumption. The FDA instructed agency staff to stop the importation of Libidus, and the agency recently stopped a shipment of 4EVERON from entering the United States. Depending on responses to these actions, the FDA may take additional enforcement steps.
Here's the FDA links if you want to read for yourself...