Food and Drug Administration approved ‘Big Penis’ is a prescription drug for sexual enhancement. The FDA has issued a warning advising consumers not to purchase or use Big Penis as the FDA lab has flagged the product ‘dangerous’.
The FDA lab has analysed and confirmed that Big Penis contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients can report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
On initial approval, FDA in a blog writes, “These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all-natural.” 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.”