FDA warns against sexual performance drugs sold on the net

The Food and Drug Administration (FDA) in the U.S. is warning consumers against several products promoted as treatments for erectile dysfunction (ED) and sexual performance enhancers. The FDA says the products are in fact illegal drugs that contain potentially harmful and undeclared ingredients. The dangerous products are Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx and 4EVERON. Such products target older adults since up to 25 percent of men 65 and older experience ED. Zimaxx is sold as a sexual enhancer for both men and women and along with other similar products is sold on web sites as "dietary supplements," but have not been approved by FDA, so there is no guarantee of their safety and effectiveness, or of the purity of their ingredients. The FDA says the 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. Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research says they present a serious risk because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure. A chemical analysis by the FDA has revealed that Zimaxx contains Sildenafil, which is the active pharmaceutical ingredient in Viagra and Revatio, prescription drugs 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 but there is no mention of any of these ingredients in any of the illegal products' labeling. 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 and ED is a common problem in this group of men. The FDA has sent warning letters to the firms marketing the products stating that the products are illegal drugs, and the 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 has already stopped the importation of Libidus, and a shipment of 4 EVERON from entering the United States and may take additional enforcement steps. The actions of the FDA are the result of an innovative survey, in which the agency analyzed 17 dietary supplements marketed on the internet to treat ED and to enhance sexual performance in men. The FDA encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat the condition. Margaret Glavin, FDA's Associate Commissioner for Regulatory Affairs, says the FDA is committed to protecting the public health by removing such illegal and dangerous products from the market.