The Food and Drug Administration (FDA) is advising consumers not to purchase or use Wonder-Erect Male Gum, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possible in some retail stores.
FDA laboratory analysis confirmed that Wonder-Erect Male Gum contains vardenafil. Vardenafil is the active ingredient in the FDA-approved prescription drug Levitra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
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