The Food and Drug Administration is advising consumers not to purchase or use WILDMAN, a product promoted and sold for sexual enhancement on various websites, including www.loveproducts.net, and possibly in some retail stores.
FDA laboratory analysis confirmed that WILDMAN contains sildenafil, tadalafil, sibutramine, desmethyl sibutramine and phenolphthalein not listed on the product label.
Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients 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.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Desmethyl sibutramine is a substance structurally similar to sibutramine. This product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it may increase the risk of cancer.
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:
Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. 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.
Refer to the links below for more information:
