FDA: ‘Low T’ Therapy Provides Few Benefits and Increased Heart Risk

iStock/Thinkstock(WASHINGTON) — You’ve seen the “Low-T” commercials targeted at Baby Boom generation men to convince them that testosterone replacement therapy is the answer to the sagging muscles, lower energy levels and sexual problems that often come with aging, but a Food and Drug Administration advisory panel reported this week there is little evidence the treatment works.

The panel voted 20-1 to tighten use of testosterone replacement drugs and require drug manufacturers to conduct tests to gauge the drugs’ risk of heart attack and stroke, according to Bloomberg News.

The FDA is not required to follow the recommendations of its expert panels, but it usually does.

According to an FDA review, the number of men with a testosterone prescription jumped from 1.3 million people in 2010 to 2.3 million in 2013.  An agency analysis found that just 50 percent of the men now taking testosterone therapy had been diagnosed with hypogonadism, the specific medical diagnosis for testosterone deficiency.

In addition, the FDA review found 25 percent of men started the therapy without lab testing to confirm they had low levels of testosterone.

The FDA report warns that testosterone therapy, even if done correctly, can often have serious health consequences.

The agency cites a study that found a 30-percent increased risk of stroke or heart attack in a group of men recently prescribed testosterone therapy.

The FDA says a second study found that men 65 and older experienced a twofold increase in heart attack risk within the first three months of starting testosterone therapy.

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