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Testosterone replacement therapies should be reserved for men with specific medical conditions that impair function of the testicles, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the advice but typically does so. The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone.
Prescriptions for "Low T," as low testosterone has been described in television commercials, have soared over the past decade, driven by an increase in use by middle-aged men with lowered testosterone levels related to advancing age. Symptoms of low testosterone include loss of libido, decreased muscle mass, fatigue and depression.
The panel voted 20-1 in favor of restricting the drugs' authorization to people with medically related low testosterone, such as a genetic disorder or a tumor. If implemented, the restriction would mean companies could not market or promote their products for age-related low testosterone, although physicians would allowed to prescribe products "off label" in any way they choose.