THE BEST Enhancer Recalled for Containing ED Drug
April 4, 2011
PARAMOUNT, Calif.AVNS Inc. voluntarily recalled THE BEST Enhancer Supplement after being informed by its manufacturer, Drive Total Energy, that FDA lab analyses found the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male erectile dysfunction (ED). The active drug ingredient is not listed on the product label, and makes these products unapproved new drugs, as far as FDA is concerned.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take other prescription drugs. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance, according to FDA.
To date, AVNS Inc and Drive Total Energy are not aware of any reports made to the FDA concerning any adverse effects associated with the use of The Best. In addition, Drive Total Energy and AVNS currently have not received any complaints from their customers.
AVNS urged consumers who have purchased these products to discontinue their use and return the products to their place of purchase for a full refund.
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