Little evidence testosterone-boosting drugs are beneficial, US regulator says
US regulator says there is little evidence to back claims for testosterone boosters, but questions studies suggesting they carry serious risk
The US Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of men are beneficial, though it is also unconvinced by studies suggesting the hormone carries serious risks.
The agency posted its review online ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the hormone.
Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testosterone therapy and heart problems in men.
The scrutiny comes amid an industry marketing blitz for pills, patches and formulations that has transformed testosterone into a multibillion-dollar market.
Advertisements for prescription gels like Fortesta and Androgel promise ageing men relief from "Low-T", a condition they link to low libido, fatigue and weight gain.
But FDA reviewers state that "the need to replace testosterone in these older men remains debatable". While testosterone levels naturally decline after age 40, it was unclear whether those lower levels actually lead to the signs commonly associated with ageing, including decreased energy and loss of muscle.