The Food and Drug Administration (FDA) is warning consumers about a “male sexual stimulant” has proven to be more potent than advertised. The FDA tested samples of Big Penis, an over-the-counter supplement promoted for sexual enhancement and discovered the unlabeled inclusion of sildenafil. Sildenafil, the active ingredient in Viagra, is an FDA-approved prescription drug for erectile dysfunction.
The issue was discovered during a random lab test at one of its International Mail Facilities. The FDA said in its release, “FDA laboratory analysis confirmed that Big Penis contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction.” Including an FDA-approved prescription drug with an over-the-counter stimulant is highly illegal, as it can lead to patients suffering severe side effects
Undeclared sildenafil in a supplement can create some very serious health concerns, adversely affecting individuals with preexisting health issues. It can interact with nitrates found in some prescription drugs, such as nitroglycerin, that are frequently taken by people with diabetes, high blood pressure, high cholesterol and heart disease. It can also lower blood pressure to dangerous levels.
Other known side effects of the drug include headaches, heartburn, flushed skin, hearing loss, vision problems, and a prolonged erection that can lead to damage to the penis. The FDA is calling for anyone experiencing these side effects after taking Big Penis to contact the agency. The FDA statement said, “Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”
Since its introduction in 1998, Viagra’s active ingredient has been found in numerous products that it’s not supposed to be in. In 2015 alone, it was discovered in more than two dozen herbal supplements, including sexual enhancers and energy drinks. Supplement manufacturers aren’t required to reveal their ingredients unless there’s a complaint and investigation. The statement from the FDA says, “FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.”