FDA Proposes Broader Testosterone Use After 5,000-Man Study Eased Heart-Risk Fears
Updated
Updated · Fortune · Jul 16
FDA Proposes Broader Testosterone Use After 5,000-Man Study Eased Heart-Risk Fears
3 articles · Updated · Fortune · Jul 16
Summary
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 hormone deficiency tied to injury or disease.
A 5,000-man FDA-mandated trial published in 2023 found no increase in heart attacks or strokes over two years, helping prompt the agency to drop a boxed heart-risk warning last year.
Nearly 800 older men in NIH-backed studies saw better erectile function, libido and modest mood gains, but little or no improvement in fatigue, memory or overall well-being.
Doctors still warn testosterone can suppress sperm production, and the Endocrine Society says men should have symptoms plus two low-test results; one Michigan study found only 12% of prescribed patients met that standard.
The proposal marks another turn in a decades-long fight over 'low T' after a 2010s marketing boom drove annual sales above $2 billion and raised fears of widespread overprescribing.