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FDA Announces Changes in Testosterone Labeling

Mar 11, 2015

Men’s testosterone levels decline as they get older, too. This can make them feel tired, depressed, and less interested in sex. But this type of low testosterone is not the same as hypogonadism.

Some doctors prescribe testosterone to men who have age-related low testosterone, not hypogonadism. This concerns the FDA, as testosterone is not approved for this use. More research is needed to determine how safe and effective it is.

With the new labeling requirements, manufacturers will clarify the approved uses of testosterone.

The FDA is also concerned that testosterone use might increase the risk of heart attack and stroke in some patients. This issue has been controversial, with research showing mixed results. Some studies have found increased risk, some have not.  


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