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.