HHS asked drugmakers to revise testosterone therapy warnings, signaling easier access for men with documented low testosterone as the agency says some long-standing safety concerns were overstated.
A clinical trial of more than 5,200 men found no meaningful rise in major cardiovascular events, prompting HHS to soften warnings tied to heart attacks and strokes.
The agency also wants to remove language saying age-related testosterone decline lacks proven safe, effective treatment and to narrow prostate cancer warnings to cases where cancer has spread beyond the prostate.
Doctors still say testosterone should be used only for men with persistent symptoms and confirmed low levels—typically after two morning blood tests—with ongoing monitoring for side effects including blood clots, irregular heart rhythms and reduced sperm production.