Drug & Device News

The U.S. Food and Drug Administration (FDA) is warning consumers not to use what have been advertised as 'dietary supplements' for treating erectile dysfunction (ED) and enhancing sexual performance: Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. '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,' said Dr. Steven Galson, Director of 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.' The FDA's chemical analysis of Zimaxx revealed that it contains sildenafil, which is the active pharmaceutical ingredient in the prescription drug Viagra.' The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. This 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.