September 17, 2014 – An FDA advisory panel consisting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee issued a recommendation regarding the intended use and the potential adverse cardiovascular effects of testosterone therapy.
The FDA advisory panel made a strong recommendation to significantly limit the uses of testosterone replacement therapy from those currently advocated by the manufacturers of these drugs. In the US, testosterone treatment is approved for use in men who have low testosterone levels due to specific medical reasons, such as chemotherapy or a genetic predisposition. Nonetheless, the manufacturers of these drugs have consistently marketed testosterone products for use in men experiencing ordinary effects of aging. The members of the panel voted overwhelmingly in favor of updating all testosterone products’ labels to restrict the intended uses of testosterone therapy. Such language “would mean companies could not market or promote their products for age-related low testosterone.”
The panel further recommended “large and randomly controlled” safety studies, “the gold standard for assessing safety and efficacy,” to evaluate the possible increased cardiovascular risks, such as heart attack and stroke.
The FDA usually follows the advice of its advisory committees. Earlier this year, the FDA issued a Drug Safety Communication, announcing it would “reassess the cardiovascular safety of testosterone therapy.” The safety statement was prompted by research showing increased risk of serious cardiovascular issues associated with testosterone therapy, including heart attack, stroke, and death.