U.S. FDA warns consumers about dietary supplements
Friday June 20, 8:43 pm ET
[Perhaps they should try a lower dose next time. Then they will be able to sell more of the supplements. Is this type of foodstuff unregulated in the US? Should have the potential to open up a lot of new possibilities for enterprising types in China and India. (Where they are already busy manufacturing generics of Viagra nd possibly also of Cialis). As far as I know Lilly/Icos has claimed that there is no interaction with nitrates. FDA may think otherwise. Perhaps that is why approval of the drug was held up.]
WASHINGTON, June 20 (Reuters) - The U.S. Food and Drug Administration (News - Websites) on Friday warned consumers against taking certain dietary supplements containing a prescription drug ingredient that could cause a sharp loss in blood pressure.
The FDA said consumers should not purchase or consume SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES or Uroprin manufactured by NVE Inc., in Newton, New Jersey and distributed by Hi-Tech in Norcross, Georgia.
The agency said the products contain the prescription-strength ingredient, tadalafil, the active ingredient in Cialis, a product of Eli Lilly and Co. (NYSE:LLY - News) that is approved in Europe to treat male erectile dysfunction.
"An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and tadalafil may cause a drastic lowering of blood pressure," the FDA said in a statement.
The agency's Office of Criminal Investigations executed federal search warrants in Georgia and New Jersey after finding the dietary supplements.
Spokesmen for NVE Inc. and Hi-Tech could not be reached for comment. |
