The FDA Listened on Estrogen. Is Testosterone Next?
The FDA needs to update labels to include age-related hypogonadism (most current use is off-label), and deschedule testosterone from Schedule III (an outdated 1980s policy).
Dr. Rachel Rubin, Dr. Mohit Khera, and Dr. Abraham Morgentaler discuss the need to modernize testosterone therapy labeling and scheduling at an FDA meeting. They argue that testosterone should not be classified as a controlled substance and that the current threshold levels for treatment are outdated. They also discuss the TRAVERSE trial, which found that testosterone does not increase the risk for heart attack, prostate cancer, or benign prostatic hyperplasia, and that it has benefits for libido and depression.
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