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When the FDA first approved testosterone replacement therapy (TRT) drugs decades ago, they approved them only for medically related low testosterone, or “hypogonadism,” a condition in which testosterone levels go down because of a medical issue, like a pituitary gland malfunction or testicle problem.

Since then, however, manufacturers of these drugs have engaged in aggressive advertising campaigns to promote the drugs as solutions for typical signs of aging, including sagging energy and muscle loss. As a result of their efforts, sales of these therapies more than doubled since 2006, and continue to rise.

However, in 2013 and again in 2014, studies came to light questioning the wisdom of using these drugs on men who were not medically diagnosed with hypogonadism. Researchers found that in men 65 and older, the drugs increased risk of heart attack, and in younger men with a family history of heart disease, the drugs increased risk three-fold.

Other tests found conflicting results. All these years later—and after thousands of plaintiffs have filed testosterone therapy lawsuits because of serious injuries—where do we stand on these drugs?

Should Men Be Boosting Testosterone Levels with Drugs?

According to Harvard Men’s Health Watch, declining testosterone is a normal part of aging. Whether that should be addressed with testosterone replacement remains controversial, since the benefit/risk ratio is still uncertain.

Studies have come in on both sides of the fence. While one study was actually halted early because of the dangerous risks of heart attacks and other blood-clot related issues, other studies, such as one reported at the 2015 American Heart Association Scientific Sessions, found no connection between the drugs and heart attack, stroke, or death. These were men with no history of heart disease, however.

In January 2014, the FDA released a safety communication warning healthcare providers and patients that they were investigating a potential link between testosterone therapy and heart attack, stroke and death. In March 2015, they released a follow-up, stating that the testosterone product labels had been updated to include information about the risks.

“The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging,” the administration stated, “even if a man’s symptoms seem related to low testosterone.”

Testosterone Therapy Not A Cure-All

Harvard Health agrees, stating: “The bottom line is that the long-term risks of TRT are still unknown, as many of these studies have limited follow-ups.” They suggest that men go through several blood tests to determine their testosterone levels (as is required for a diagnosis of hypogonadism), stating that several tests are required since levels can fluctuate daily, and are influenced by medications and diet.

The caution that even if levels are low, TRT is not always the best option. Weight gain is more likely to have an effect on levels than aging, for example—which means that weight loss would be a more effective treatment. Other medical conditions can also affect levels, for which treatment could reverse the situation.

Finally, they warn that the benefits of TRT are often much less dramatic than men expect. A 2016 study, for instance, found that though men taking the drugs experienced improvements in sexual function, they saw only slight mood enhancement and no changes in vitality or muscle strength.

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