Black Storm: Public Notification - Undeclared Drug Ingredient[Posted 11/24/2014]
ISSUE: FDA is advising consumers not to purchase or use Black Storm. FDA laboratory analysis confirmed that Black Storm contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat 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: Black Storm is a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
RECOMMENDATION: Do not purchase or use Black Storm.
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
[11/24/2014 - Tainted Sexual Enhancement Products - FDA]