The FDA only approves the use of TRT in men who suffer from low testosterone levels in conjunction with an associated medical condition confirmed by laboratory tests. It is NOT an approved treatment for men with low testosterone due to aging stating, “the benefits and safety of this use have not been established.”
In the Safety Announcement released on March 3, the FDA is now requiring manufacturers to make specific changes for labeling testosterone products:
- There must be clarification of FDA-approved uses for TRT.
- There must be a warning for possible increased risk of heart attacks and stroke associated with testosterone use.