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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",