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FDA warns of unapproved ED
‘supplements’
Promoted for treating erectile dysfunction,
products contain prescription agents, are unapproved and illegal.
FDA is warning consumers not to purchase or consume Zimaxx,
Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These
products are promoted and sold on Web sites as "dietary
supplements" for treating erectile dysfunction (ED) and enhancing
sexual performance, but they are in fact illegal drugs that contain
potentially harmful undeclared ingredients. 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 agency noted
in a news release.
FDA advises consumers who have used any of these products to discontinue
use and to consult their health care provider. FDA encourages anyone
experiencing ED to seek guidance from a health care provider before
purchasing a product to treat this medical condition.
Chemical analysis by FDA revealed that Zimaxx contains sildenafil, the
active ingredient in Viagra (Pfizer). The other products contain
chemical ingredients that are analogues of either sildenafil or
vardenafil (Levitra—Bayer, GlaxoSmithKline, Schering). These
ingredients are not disclosed in any of the illegal products' labeling.
FDA emphasized.
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. FDA instructed agency staff to stop the
importation of Libidus, and the agency recently stopped a shipment of
4EVERON from entering the United States. Based on responses to these
actions, FDA may take additional enforcement steps.
Web links
Related resources on www.pharmacist.com
Contact the writer: L. Michael Posey, BPharm, Pharmacy Today
Posted July 13, 2006, 4:45 pm EDT
| Promoted for treating erectile dysfunction, products contain prescription agents, are unapproved and illegal. |
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