FDA MedWatch Safety Alert: Nationwide Recalls of Dietary Supplement Stamina-Rx

Posted June 22, 2009

Nationwide Recalls of Dietary Supplement Stamina-Rx

Unapproved Ingredient Present in Supplement 

Food and Drug Administration (FDA) and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx.  FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil.  Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that are FDA-approved for the treatment of erectile dysfunction (ED).  

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide.  Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm or by phone 1-800-FDA-1088 or by returning the postage paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax 1-800-FDA-0178.

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