July 12, 2006 — The FDA today warned consumers not to purchase or consume
seven products that are promoted and sold on web sites as “dietary
supplements” for treating erectile dysfunction
(ED) and enhancing sexual performance.

The products — Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and
4EVERON — are “illegal drugs that contain potentially harmful undeclared
ingredients,” states an FDA news release.

“These products have not been approved by FDA, and there is no guarantee
of their safety and effectiveness, or of the purity of their ingredients,”
the FDA’s news release continues.

The FDA is advising consumers who have used any of these products to
dysfunction pills
use and to consult their health care provider. The FDA also
encourages anyone experiencing ED to seek guidance from a health care provider
before purchasing a product to treat this medical condition.

Stealth Ingredients

“These products threaten the public health because they contain
undeclared chemicals that are similar or identical to the active ingredients
used in several FDA-approved prescription drug products,” says Steven
Galson, MD, MPH, in the FDA’s news release. Galson directs the FDA’s Center for
Drug Evaluation and Research.

“This risk is even more serious because consumers may not know that
these ingredients can interact with medications and dangerously lower their
blood pressure,” Galson continues.

The banned products contain chemicals similar to those in the prescription
ED drugs Viagra and Levitra. The FDA analyzed the products and found that
Zimaxx contains sildenafil, Viagra’s active ingredient. The other illegal
products contain chemical ingredients that are similar to either sildenafil or
vardenafil, Levitra’s active ingredient.

“There is no mention of any of these ingredients in any of the illegal
products’ labeling,” states the FDA.

Health Risk

The illegal products’ undeclared ingredients may interact with nitrates
found in some prescription drugs (such as nitroglycerin, Isordil, and Imdur)
and lower blood pressure to dangerous levels.

People with diabetes, high
blood pressure, high cholesterol, or
heart disease
often take nitrate medications. ED is a common problem in men with those
conditions, the FDA notes.

Those men may seek ED products that claim to be “all natural” or
that claim to lack the active ingredients used in FDA-approved ED drugs, states
the FDA. But those claims are false, misleading, and potentially dangerous,
according to the FDA.

The FDA also warns that because it doesn’t know where the illegal products
are made, there is no assurance that the ingredients are safe, effective, or
pure.

The FDA has sent warning letters to the products’ marketers, is working to
stop Libidus and 4EVERON from entering the U.S., and may take other ed tabs

actions.

The FDA’s actions follow its first survey of 17 dietary supplements marketed
on the Internet to treat ED and enhance men’s sexual performance.

“Our survey found that many of the so-called ‘dietary brand generic online viagra

marketed as treatments for erectile dysfunction actually contain nondietary
chemicals, including chemicals used as active ingredients in FDA-approved
drugs,” says Margaret Glavin, the FDA’s associate diabetic impotence for
regulatory affairs, in the FDA news release.

“The claims made for these products were in fact claims made for the
undeclared nondietary chemicals they contain, which rendered them illegal
drugs,” Glavin continues. She adds that the FDA “is committed to
protecting the public health by removing such illegal and dangerous products
from the market.”