Public Notification: Rock Hard Extreme and Passion Coffee Contain Undeclared Drug Ingredient

[12/30/2010] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Rock Hard Extreme and Passion Coffee, products promoted and sold as dietary supplements for sexual enhancement. 


These products are promoted and sold on various websites, such as www.drivetotalenergy.com,  and possibly in some retail stores.

FDA laboratory analysis confirmed that Rock Hard Extreme and Passion Coffee contain the undeclared ingredient sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED). 



The 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.

Consumers should stop using these products immediately and throw them 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:

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
• 
  

Note: This notification is to inform the public of a growing trend of products marketed as 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 on the market 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:

• Tainted Sexual Enhancement Products
• Subscribe to the RSS feed
• Tainted Supplement Consumer Article

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druginfo@fda.hhs.gov

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http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm238411.htm