US Pharm. 2014;39(10):7.
Silver Spring, MD—An FDA advisory panel has voted 20-1 to restrict the use of testosterone replacement therapies to serious medical conditions that cause testosterone deficiency, such as hypogonadism due to genetic disorders or chemotherapy. The panel noted that there is no clear evidence that these therapies are effective for treating age-related low testosterone, known as low T. Between 2009 and 2013, the use of these products increased by 65%, primarily driven by higher usage in patients with low levels of the hormone caused by aging. One panel member noted that the FDA’s goal is to “rein in the inappropriate advertising and use of these drugs.” The advisory panel also recommended that pharmaceutical companies be required to conduct additional studies to assess the cardiovascular risk of these products for heart attack and stroke.
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