The FDA has warned consumers not to purchase or consume seven products that are promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction (ED) and enhancing sexual performance.
The products -- Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and 4EVERON -- are “illegal drugs that contain potentially harmful undeclared ingredients,” states an FDA news release.
“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 FDA’s news release continues.
The FDA is advising consumers who have used any of these products to discontinue use and to consult their health care provider. The FDA also encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat this medical condition.
“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,” says Steven Galson, MD, MPH, in the FDA’s news release. Galson directs 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,” Galson continues.
The banned products contain chemicals similar to those in the prescription ED drugs Viagra and Levitra. The FDA analyzed the products and found that Zimaxx contains sildenafil, Viagra’s active ingredient. The other illegal products contain chemical ingredients that are similar to either sildenafil or vardenafil, Levitra’s active ingredient.
“There is no mention of any of these ingredients in any of the illegal products' labeling,” states the FDA.
The illegal products’ undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin, Isordil, and Imdur) and lower blood pressure to dangerous levels.
People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrate medications. ED is a common problem in men with those conditions, the FDA notes.
Those men may seek ED products that claim to be “all natural” or that claim to lack the active ingredients used in FDA-approved ED drugs, states the FDA. But those claims are false, misleading, and potentially dangerous, according to the FDA.
The FDA also warns that because it doesn’t know where the illegal products are made, there is no assurance that the ingredients are safe, effective, or pure.
The FDA has sent warning letters to the products’ marketers, is working to stop Libidus and 4EVERON from entering the U.S., and may take other enforcement actions.
The FDA’s actions follow its first survey of 17 dietary supplements marketed on the Internet to treat ED and enhance men’s sexual performance.
“Our survey found that many of the so-called 'dietary supplements' marketed as treatments for erectile dysfunction actually contain nondietary chemicals, including chemicals used as active ingredients in FDA-approved drugs,” says Margaret Glavin, the FDA’s associate commissioner for regulatory affairs, in the FDA news release.
“The claims made for these products were in fact claims made for the undeclared nondietary chemicals they contain, which rendered them illegal drugs,” Glavin continues. She adds that the FDA “is committed to protecting the public health by removing such illegal and dangerous products from the market.”
By Miranda Hitti, reviewed by Louise Chang, MD
SOURCE: News release, FDA.