FDA Advises Drugmakers to Conduct Further Studies on Testosterone Heart Risk

An advisory panel to the U.S. Food and Drug Administration (FDA) recently voted 20-1 that further assessment of the health risks of testosterone therapy is needed among drugmakers. Among the panel, 16 voted that testosterone should only be studied in some situations, Bloomberg reported.

testosterone side effectsThe panel also agreed that the FDA should revise who should be prescribed testosterone medications. This backs up the claim that there is little evidence supporting the effectiveness of testosterone replacement therapies for treating low T due to aging.

Use of testosterone began in the 1950s among men who had medical conditions leading to testosterone deficiencies, such as testicular damage from chemotherapy. In recent years, however, use has grown substantially among men with no other reason for low testosterone other than natural aging.

“About 20 percent of patients on the treatments don’t have laboratory evidence showing they need them,” the Bloomberg article states.

Previous studies have linked testosterone replacement therapies to an increased risk of heart attack, stroke or death. The study, published in PLOS ONE, an international, peer-reviewed online publication in January, 2014, is a part of the growing body of research on testosterone heart risk that raises concerns about the increased risk associated with taking testosterone therapy.

The recommendations from the FDA advisory panel would lower the number of patients able to take low T treatments. Drugmakers would be required to conduct additional testing to determine a serious connection with cardiovascular risks. While the FDA often pays close attention to the panel’s advice, they’re not required to follow it.

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