US Proposes Testosterone Label Overhaul for 5,200-Men Study, Easing Age and Cancer Limits
Updated
Updated · Reuters · Jun 18
US Proposes Testosterone Label Overhaul for 5,200-Men Study, Easing Age and Cancer Limits
3 articles · Updated · Reuters · Jun 18
Summary
The U.S. health department proposed label changes for testosterone replacement therapies that would drop limits on use in men with age-related low testosterone and narrow prostate-cancer contraindications to metastatic disease.
A review of newer evidence, including a study of more than 5,200 men, found no meaningful rise in major cardiac events such as heart attack and stroke, leading the FDA to say the old limitation is no longer warranted.
The revised labeling would also soften warnings on enlarged prostate after the FDA found no worsening in men with mild to moderate symptoms, while still calling for assessment and monitoring during treatment.
The move could widen prescribing to more men and extends the administration's rollback of hormone-treatment restrictions after the FDA last year removed boxed warnings on heart risks but added blood-pressure warnings.