ISSUE: FDA is advising consumers not to purchase or use Arize, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Arize contains sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for 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.
BACKGROUND: Arize is promoted and sold for sexual enhancement on various websites and in some retail stores.
RECOMMENDATION: Do not purchase or use Arize. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- 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
[08/11/2014 - Pubic Notification - FDA]