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Benefits of Testosterone Therapy Questioned by FDA

Sep 11, 2014

Several conflicting studies have questioned the safety and effectiveness of testosterone replacement therapy (TRT). Reports of heart disease, heat attacks and other negative side effects have caused increased scrutiny into TRT.

In response to claims that TRT is causing health problems in men, the Food and Drug Administration (FDA) has conducted an extensive review of the testosterone drugs available on the market. The FDA report, released in advance of a September 17, 2014 meeting reveals the FDA’s concerns about the continued effectiveness of TRT.

An initial study in 2013 at the University of Texas reviewed the use of TRT in tens of thousands of men and discovered no reason to believe that TRT was linked to an increased risk of heart disease or heart attack. A conflicting study at the University of California Los Angeles revealed that men with existing heart conditions and those over the age of 65 doubled their risk for heart attack after using TRT for more than one year.

The FDA’s review of the studies confirmed and disconfirmed some of the findings that the private and educational sector discovered. For instance, on the question of whether TRT contributed to heart disease, the FDA’s report concludes that “there is no convincing evidence of a causal association between testosterone therapy and adverse cardiovascular events.”

At the same time however, the FDA did question the actual benefit of TRT. On the one hand, the report noted a positive correlation between TRT and bone density, lean muscle mass and fat reduction. At the same time, the report also noted that nearly 25% of testosterone prescriptions are for populations that have not yet been diagnosed with low levels of testosterone.

All in all, the FDA found that though the benefits of TRT may be unclear in men who have not been diagnosed with deficient levels of testosterone, the risk for cardiovascular disease is unconvincing.

Nonetheless, lawsuits challenging popular testosterone drugs such as Androgel, Axiron, Fortesta, Testopel, Striant, Delatestryl, Testim, and Androderm are on the rise.

The prescription drug lawyers at Peterson & Associates, P.C.are investigating and assisting men who have developed heart disease after being placed on a testosterone regimen.

Categories: Class Action Lawyer

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