Last month’s FDA proposal would rewrite testosterone labels so doctors can prescribe it for age-related symptoms such as low libido and erectile dysfunction, not just medically caused hormone deficiency.
A 2023 FDA-mandated trial of 5,000 men found no higher rate of heart attack or stroke with testosterone, while NIH studies in nearly 800 older men showed gains in sexual function and only small mood benefits.
Those findings do not support testosterone as a general fix for fatigue, memory or overall well-being, and experts say overdiagnosis remains a risk because aging symptoms overlap with low-testosterone complaints.
One Michigan study found only 12% of men receiving testosterone met guideline criteria requiring symptoms plus two low blood tests, underscoring concerns about loose prescribing.
Doctors still caution against use in men trying to have children and urge care in prostate-cancer cases, while a 2022 paper found only 1 in 7 online prescribers asked basic fertility-screening questions.