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    FDA panel’s vote on TRT draws reaction from urologists

    An FDA advisory committee has voted to restrict indications for testosterone replacement therapy (TRT) and require additional clinical trials to test the safety of the drugs, decisions that have drawn mixed reactions from urologists.

    The panel’s conclusions reinforce the need to conduct a thorough diagnosis based on serum testosterone levels and clinical symptoms and to follow patients in whom treatment is indicated, according to John J. Mulcahy, MD, PhD, a member of the Urology Times Editorial Council. Abraham Morgentaler, MD, a urologist who made an oral presentation during the meeting’s public hearing portion, called the vote “a step backwards for our patients and for science.”

    Related - Data fail to support concerns over T therapy, CV risk

    “There are many physicians and other providers treating low T without any background, and many are prescribing without proper patient evaluation or follow-up,” Dr. Mulcahy said, pointing out that 60% of prescriptions are written by primary care physicians versus only 20%-25% by urologists and endocrinologists, ”the ones usually with the most testosterone prescribing expertise.”

    “For physicians treating men for symptoms of low T, it is important that an accurate description of symptoms be obtained as well as serum levels of T and other appropriate related hormones,” said Dr. Mulcahy, a urologist in Madison, AL. “If low T is documented, a trial of TRT may be instituted with follow-up to ascertain if the therapy has been effective in improving symptoms and that the T level has been brought to a satisfactory range or that dose adjustment is needed.”

    The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee voted last week 20-1 to limit the prescribing of testosterone therapies to men with specific medical conditions and not those with an age-related decline in serum testosterone, the New York Times reported.

    “Because the intended use of testosterone is ‘replacement therapy,’ the FDA has only required that an investigational testosterone treatment demonstrate acceptable restoration of serum testosterone concentrations to the normal range to gain FDA approval,” the FDA said in a background statement prior to the meeting. “This approach is reasonable for patients with ‘classic’ hypogonadism (ie, those who have an absence or deficiency of testosterone due to documented testicular or hypothalamic/pituitary disease). In these patients, replacing testosterone is necessary for the development or maintenance of secondary sexual characteristics.

    “A more controversial treatment population is aging men who have low serum testosterone concentrations for no apparent reason other than age, and who experience non-specific symptoms of aging that overlap with those of classic hypogonadism,” the statement said.


    Next - Dr. Morgentaler: Vote "a step backwards"

    More on Testosterone

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    Decision to use testosterone must be individualized

    Testosterone dependence: How real is the risk?

    Long-term data show no link between TRT, prostate Ca

    Testosterone, clomiphene yield similar satisfaction

    FDA rejects petition for black box warning on T meds


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