The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 10ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com.
FDA laboratory analyses confirmed that VITAFER-L Gold 10ml contains tadalafil not listed on the product label.
Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. FDA approval of Cialis is restricted to use under the supervision of a licensed health care professional. This 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 consumers 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:
- 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.
