The US Food and Drug Administration (FDA) has issued a warning to consumers not to purchase or consume certain stamina enhancing dietary supplements containing Cialis, a prescription drug ingredient thought to pose possible health risks.
The products, being sold over-the-counter as dietary supplements and claimed to increase stamina, confidence and performance, are manufactured by NVE in Newton, New Jersey and distributed by Hi-Tech in Norcross, Georgia. The products include Sigra, Stamina Rx and Stamina Rx for Women, Y-Y, Spontane ES and Uroprin.
The FDA said in a statement that the products contain the prescription-strength drug ingredient, tadalafil, the active ingredient in Cialis, an Eli Lilly product approved in Europe to treat male erectile dysfunction and awaiting approval in the US.
An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and tadalafil may cause a drastic lowering of blood pressure, said the FDA. It adds that there is real danger that this product may be taken by patients taking nitrates since erectile dysfunction is often a common problem in people with diabetes, hypertension (high blood pressure), hyperlipidemia (high cholesterol), ischemic heart disease and in people who smoke.
FDA's Office of Criminal Investigations has carried out federal search warrants in Georgia and New Jersey following the discovery of these dietary supplements.