WASHINGTON – The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by recent studies suggesting the hormone carries serious risks.
The agency posted its review online ahead of a public meeting later this month to discuss the benefits and risks of treatments that increase the male hormone. Regulators agreed to convene the Sept. 17 meeting after two federally funded studies found links between testosterone therapy and heart problems in men.
The scrutiny comes amid a marketing blitz for new pills, patches and formulations that has transformed testosterone into a multibillion-dollar market.
Advertisements for prescription gels like Fortesta and Androgel promise men relief from common signs of aging, including low libido, fatigue and weight gain.