Published:
06/18/2009
June
18, 2009
Hi-Tech
Pharmaceuticals Inc. of Norcross, Ga., is recalling all lots
of its dietary supplement Stamina-Rx because it contains an
unapproved drug, benzamidenafil, which may pose health risks.
The
supplement is marketed as a "natural alternative"
to prescription drugs for erectile dysfunction.
Benzamidenafil,
which isn't noted on the Stamina-Rx label and it isn't approved
by the FDA, belongs to the same class of drugs as the active
ingredients in the erectile dysfunction drugs Viagra, Cialis,
and Levitra.
"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,"
states a Hi-Tech Pharmaceuticals news release posted on the
FDA's web site.
FDA
tests showed benzamidenafil in one lot of Stamina-Rx, but
all lots of the product are being recalled because it is "an
unapproved and misbranded drug," states Hi-Tech Pharmaceuticals.
The
company notes that Stamina-Rx is mainly sold in health food
and drug stores nationwide.
Hi-Tech
Pharmaceuticals advises consumers to stop using Stamina-Rx
immediately and report any adverse effects to the company
by calling 888-855-7919 from 9 a.m. to 5 p.m.
STAMINA
RX LABEL:
| 1. |
Xanthoparmelia Scabrosa - induces smooth
muscle relaxation, allowing for maximum arterial dilation
and increased bloodflow. |
| 2. |
Cnidium Monnier - increases nitric
oxide release and inhibits PDE-5, allowing erections
to be sustained for longer periods of time. |
Also
included in Stamina-Rx® are four key components
incorporated for their time-proven ability to enhance sexual
performance.
| 1. |
Yohimbe
8% Extract - Yohimbine HCL, the active constituent,
increases blood flow to the penis and dramatically increases
libido. Stamina-Rx® contains the highest percentage
yohimbine hcl found in the world! Again, beware of the
competition! Products containing inferior yohimbe often
have NO yohimbine hcl ... rendering it useless! |
| 2. |
L-Arginine - Increases natural production
of nitric oxide, leading to a more rigid erection. |
| 3. |
Gamma Amino Butyric Acid - Increases
dopamine levels, igniting a euphoric feeling and increasing
sensations during orgasm. |
| 4. |
Epimedium
/ Horney Goat Weed - Increases the sex drive
as effectively as any compound known to science! Stamina-Rx®
uses a 20:1 extract (5 times stronger than the competition!)
to ensure "MAXIMUM Stimulation!" |
|
