[04/16/2021] Update: FDA attempted several times to contact Otwo to discuss how the company can protect consumers from these dangerous products, most recently on April 6, 2021. This product was sold by Otwo via Amazon fulfillment. See FDA’s press release for additional information.
[12-17-2020] The Food and Drug Administration is advising consumers not to purchase or use Triple SupremeZen Extreme 3500, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
FDA laboratory analysis confirmed that Triple SupremeZen Extreme 3500 purchased from Amazon.com contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approvals of Viagra and Cialis are 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.
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.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs 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.
Please refer to the links below for more information: