The FDA has warned consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4Everon, all products promoted and sold on websites as dietary supplements for treating erectile dysfunction (ED) and enhancing sexual performance.
The regulator said these products are not supplements but illegal drugs that contain potentially harmful undeclared ingredients. The products have not been approved by the FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.
Chemical analysis by the agency revealed that Zimaxx contains sildenafil, the active pharmaceutical ingredient in Pfizer’s Viagra. The other products contain chemical ingredients that are analogues of either sildenafil or vardenafil, the active ingredient in GlaxoSmithKline and Schering-Plough’s Levitra.
There is no mention of any of these ingredients in any of the illegal products’ labeling. This 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.
The FDA has advised consumers who have used any of these products to discontinue use and consult their healthcare provider.