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FDA skeptical on testosterone drugs

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 studies suggesting the hormone carries serious risks.

The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of 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 an industry marketing blitz for new pills, patches, and formulations that has transformed testosterone into a multibillion-dollar market. Advertisements for prescription gels such as Fortesta and Androgel promise aging men relief from ‘‘Low-T,’’ a condition they link to low libido, fatigue, and weight gain.


But FDA reviewers are skeptical.

‘‘The need to replace testosterone in these older men remains debatable,’’ they say. While testosterone levels naturally decline after age 40, they add, it is unclear whether those lower levels actually lead to the signs commonly associated with aging, including decreased energy and loss of muscle.