[11-21-2013] The Food and Drug Administration (FDA) is advising consumers not to purchase or use "Alpha Male", a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
FDA laboratory analysis confirmed that Alpha Male contains aminotadalafil, sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, dimethylsildenafil, and sildenafil. Aminotadalafil is an analogue of tadalafil, the active ingredient in Cialis, an FDA approved prescription drug for Erectile Dysfunction (ED). Sulfosildenafil, sulfoaildenafil, hydroxythiohomosildenafil, and dimethylsildenafil are structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED). These undeclared ingredients 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.
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178