Dr. Charles Runels, MDOn 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
dogfood.
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...