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Senior Citizens & Sex
FDA Puts Beware Label on Supplements Sold for Sexual
Enhancement
Don't use Zimaxx, Libidus, Neophase, Nasutra,
Vigor-25, Actra-Rx and 4EVERON
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FDA Says Don't Use |
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 Zimaxx
is sold as sexual enhancer for both men ($59.95) and women
($49.95). |
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July 12, 2006 Senior citizens and other consumers
were warned today by the U.S. Food and Drug Administration not to buy or
consume several products promoted as treatments for erectile dysfunction
and enhancing sexual performance. The FDA put the "beware label" on
seven,
saying "they are in fact illegal drugs that contain potentially harmful
undeclared ingredients."
The dangerous products are Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx
and 4EVERON. Older adults are most likely the targets of
these marketers, since up to 25 percent of men 65 and older experience
ED.
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on
Senior Citizens & Sex |
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These products, promoted and sold on web sites as
"dietary supplements," have not been approved by FDA, and there is no
guarantee of their safety and effectiveness, or of the purity of their
ingredients.
FDA advises consumers who have used any of these
products to discontinue use and to consult their health care provider.
"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. This risk is even more serious because consumers may not know
that these ingredients can interact with medications and dangerously
lower their blood pressure," said Dr. Steven Galson, Director of FDA's
Center for Drug Evaluation and Research.
Chemical analysis by FDA revealed that Zimaxx
contains sildenafil, which is the active pharmaceutical ingredient in
Viagra, a prescription drug approved in the United States to treat ED.
The other products contain chemical ingredients
that are analogues of either sildenafil or a pharmaceutical ingredient
called vardenafil. Vardenafil is the active ingredient in Levitra, a
prescription drug that, like Viagra, is approved in the United States to
treat ED.
There is no mention of any of these ingredients in
any of the illegal products' labeling.
This deception poses a threat to consumers because
the undeclared ingredients may interact with nitrates found in some
prescription drugs (such as nitroglycerin) and lower blood pressure to
dangerous levels. Consumers with diabetes, high blood pressure, high
cholesterol, or heart disease often take nitrates.
ED is a common problem in men with these
conditions, and they 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.
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 side-effects
associated with the products' consumption.
The FDA instructed its staff to stop the
importation of Libidus, and the agency recently stopped a shipment of 4
EVERON from entering the United States. Based on responses to these
actions, FDA may take additional enforcement steps.
Today's actions follow a first-of-its-kind FDA
survey, in which the agency analyzed 17 dietary supplements marketed on
the internet to treat ED and to enhance sexual performance in men.
"Our survey found that many of the so-called
'dietary supplements' marketed as treatments for erectile dysfunction
actually contain non-dietary chemicals, including chemicals used as
active ingredients in FDA-approved drugs," said Margaret O'K. Glavin,
FDA's Associate Commissioner for Regulatory Affairs.
"The claims made for these products were in fact
claims made for the undeclared non-dietary chemicals they contain, which
rendered them illegal drugs. FDA is committed to protecting the public
health by removing such illegal and dangerous products from the market."
The FDA encourages anyone experiencing ED to seek
guidance from a health care provider before purchasing a product to
treat this medical condition.
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