The US Food and Drug Administration said Thursday it is requesting updates to prescribing information for testosterone replacement therapies, including removing a limitation stating that safety and effectiveness in men with age-related low testosterone have not been established.

The agency said the move follows new evidence, including a trial of more than 5,200 men, which found no meaningful increase in major cardiovascular events among patients receiving testosterone therapy.

The FDA also proposed updating prostate-cancer language so testosterone therapies would be avoided only in men with metastatic disease, rather than all men with known or suspected cancer. The agency said available data have not shown increased prostate-cancer risk in treated patients, though long-term uncertainties remain.

The agency is also seeking updated warnings on enlarged prostate, saying clinical data do not show worsening symptoms in men with mild to moderate disease, while recommending monitoring for those with severe symptoms.

Drugmakers with FDA-approved testosterone products, including AbbVie (ABBV), Teva Pharmaceutical Industries (TEVA), Viatris (VTRS), Amneal Pharmaceuticals (AMRX) and Perrigo (PRGO), may be affected by the requested labeling changes.