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FDA Talk Paper
T03 -48
]""" 20, 2003
Media lnquirie. 301 -827 -6242
CO<lSUIllef lnquirie. 8SB -INfO -FDA
FDA Public Health Advisory:
FDA 'Varns Consumers Against
Taking the Following Dietary
Supplements-SIGRA. STAMINA Rx
and STAMINA Rx for 'Vornen, Y-Y.
Spontane ES and Uroprin
Today. t!,., Food and Drug Admi.JMatioo (FDA) is warning
not to purchas<. or C~ the following product.
SIGRA, STk\1INA Rx and STk\1INA Rx for Women, Y-Y,
Spontane ES and Uropm. manufactured b y NVE , Inc .. in
N=tO<l, N.J. and <htributed by Hi-Tech in Norem». Ga. The",
product,. which ar~ b<:mg =keted as diotary o;upplement •.
actually contain a pre =iptioo drug ingredient that pose, p,»sWk
b<.alth risb. The products are being >old over -the-counter and
are claiming to increase >tamina, coofideoc", and peflormaoc,,_
CO<lSU!llefS
FDA has detennined that the products actually contain the
pre scriptioo- >lrength drug ingredient, tadalafiL Tadalafil is the
arm'., ingredient in Cialis , an Eli Lilly product approved in E..-Of>"
to treat mal. erectile dysfunction. An interaction b<:rn'eef! certain
pre scription drugs containing nitrate s (o;och as nitroglycerin) and
tadalafil may cau,," a drastic lowering ofblood pre s...-". There is
real danger that this product may k taken by patients takmg
nitrate s since erectile dysfunction is often a common problem in
peopk with diabetes, hypertension (high blood pre '>Ure) ,
hyperlipidemia (high chok,terof), i>chemic lI<;art di><;"", and in
peopk who =eke _
FDA' , Office of Criminal lnve >tigation>, with ",>i>tance from
FDA' , N e\\' Jer>ey and Atlanta Di>trict" executed conrurrent
federal ",arch warrant, in Georgia and N ew Jer>ey after finding
the", dietary >Upplement:,_
C<lffiU!11efS who have u=:i the", product, and have medical
COOCertl>
>hould con>U!t with ~ lI<;alth care provider,_
All co,rnlmer> >hould II<; aware of the
product,_
ffik~
",<;<>ewed with the",