FDA warns doctors about prescribing testosterone-boosting drugs for men

March 5, 2015 4:33 PM

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The Food and Drug Administration, FDA, is issuing warnings to doctors who are over-prescribing testosterone-boosting drugs for men. The FDA says that these popular treatments have not been approved as safe or effective for common issues in aging men, such as libido and fatigue. The consumer advocacy group, Public Citizen, petitioned the FDA last February to add a boxed warning – the most severe – to the testosterone drugs about heart risk. The petition was rejected by the FDA because of “insufficient evidence” to make such a warning.

The FDA is now looking for new labeling for these drugs that points out their use for low testosterone levels that are caused by disease and injury, not aging. They also warn that these drugs can increase the risk of heart attacks, stroke, and other cardiovascular issues. The drug makers must add th...

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