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Conditions: Low Testosterone

Testosterone Controversy Continues

Testosterone Controversy ContinuesLast week, the U.S. Food and Drug Administration (FDA) announced two labeling changes now required for prescription testosterone products.

First, labels should clarify the approved uses of testosterone. Specifically, the FDA has approved testosterone therapy for the treatment of hypogonadism – low testosterone caused by medical conditions. This may include problems with the testes, pituitary gland, or other parts of the brain involved with testosterone production.

This change is prompted by concerns that physicians are prescribing therapy for men with age-related low testosterone, who do not have hypogonadism. “The benefits and safety of this use have not been established,” according to an FDA statement dated March 3, 2015.

The second label change reflects recent data showing an increased risk of heart attack and stroke among men on testosterone therapy. However, some experts have questioned the reliability of this data. Last spring, in fact, 25 medical societies, including the Sexual Medicine Society of North America, petitioned JAMA to retract a study it had published in November 2013, as news of data errors emerged.

Nevertheless, the FDA now requires testosterone manufacturers to include information about possible cardiovascular risks. It also requires manufacturers to conduct clinical trials to further investigate this potential link.


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