ISSUE: FDA is advising consumers not to purchase or use “Bullet Proof,” a product promoted and sold for sexual enhancement on various websites and in some retail stores. FDA laboratory analysis confirmed that “Bullet Proof” contains tadalafil, the active ingredient in Cialis, 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: These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”
RECOMMENDATION: Consumers should stop using this product immediately and throw it away. 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
[05/07/2013 - Public Notification - FDA]