(Reuters) – The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products.
The FDA said it is recommending label changes based on results from a clinical trial testing cardiovascular effects of testosterone-replacement therapy in middle-aged and older men with hypogonadism – a condition in which the body does not produce enough of the testosterone hormone.
The agency also said it is recommending adding results from the trial to the labeling in all testosterone products, as well as a new warning about increased blood pressure for such formulations which do not already include it in their labeling.
Current FDA-approved testosterone formulations include oral, topical gel, transdermal patch and injection.
(Reporting by Sneha S K; Editing by Krishna Chandra Eluri)
