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Manufacturers of approved prescription testosterone products must change their labeling to clarify the approved uses of the medications and to include a new safety warning, .
Testosterone is officially OK'd by the agency as a replacement therapy only for men who have low testosterone for medical reasons such as disorders of the brain, pituitary gland, or testicles that cause hypogonadism.
The FDA said it had become aware that testosterone therapy was being used extensively for men with low testosterone due to aging and/or in the absence of a recognized disorder, which would signify a different approach to risk-versus-benefit calculations.
Some studies have reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, the FDA said. Consequently, it will require that labels disclose a possible increased risk of heart attacks and strokes, though not with a "black box" warning.
The requirement comes after the agency evaluated the risk of stokes, heart disease, and death related to FDA-approved testosterone products more than a year ago, which followed two studies raising questions about the risk of testosterone therapy.
Healthcare professionals should prescribe testosterone for men only when the medical conditions are confirmed by laboratory tests, and they should talk with patients about potential risks when prescribing testosterone, according to the FDA.
The agency also asked clinicians and patients to report any adverse events or side effects to its program.