• 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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