FDA MedWatch – Thumbs Up 7 Blue 69K by Bit & Bet

TOPIC: Thumbs Up 7 Blue 69K by Bit & Bet: Recall – Due to Presence of Undeclared Sildenafil and Tadalafil

AUDIENCE: Consumer, Health Professional

ISSUE: Bit & Bet LLC is recalling all lots of Thumbs Up 7 Blue 69K because FDA analysis has found the product to contain undeclared sildenafil and tadalafil.  The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K with undeclared sildenafil and tadalafil may experience serious health risks. For example, phosphodiesterase (PDE-5) inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Bit & Bet LLC has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: Sildenafil and tadalafil are ingredients known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction. 

This tainted product is marketed as a dietary supplement for male sexual enhancement

RECOMMENDATIONS: 

• Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and discard them.
• Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and consumers 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.