The Food and Drug Administration (FDA) is warning men not to buy or use a number of so-called dietary supplements marketed to treat erectile dysfunction and improve sexual performance. The supplements, sold under the names Zimaxx, Libidus, Neophase, Vigor-25, Actra-Rx, and 4EVERON, were tested by the FDA and found to contain either sildenafil, the active ingredient in the erectile dysfunction drug Viagra; vardenafil, the active ingredient in Levitra; or chemicals similar to those drugs. These ingredients were not listed on the products’ labels.
In a warning statement to consumers, the FDA said that the presence of undeclared drugs in the supplements pose a threat to public health. While sildenafil and vardenafil are effective at helping men achieve and sustain erections, they are not safe for all men to take. They can interact with nitrates, a class of drug commonly taken by men to treat congestive heart failure and angina, causing dangerously low blood pressure. In addition, because it isn’t known where or how the sildenafil and vardenafil found in the supplements were made, there’s no way of knowing whether they are safe, effective, and free of contaminants.
It’s illegal to sell a prescription drug without FDA approval, and the FDA has sent warning letters to the companies who make the supplements in question. The letters also warned the companies about making misleading claims on their labels, since any effectiveness is probably due to the sildenafil or vardenafil rather than any natural ingredients the supplement may contain. The FDA has intercepted a shipment of one of the products and may take further action — in the meantime, it’s best to steer clear of any of these so-called natural remedies that may still be available online or elsewhere.