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FDA Announces Changes in Testosterone Labeling

FDA Announces Changes in Testosterone LabelingThe U.S. Food and Drug Administration (FDA) has announced new requirements in the labeling of prescription testosterone products.

The labels must now include information on the approved use of the products and the possible increased risk of heart attacks and strokes.


FDA announces changes in testosterone labeling. (Click to tweet)


In men, testosterone is produced by the testes. This hormone gives men their masculine characteristics, including facial hair, a lower voice, and increased muscle mass. It’s also important for men’s reproductive health and helps drive their libido.

The FDA has approved prescription testosterone for men with low levels due to hypogonadism. For these men, problems with testes, pituitary gland, and other parts of the brain prevent the body from making enough testosterone. Cancer treatment can also cause hypogonadism in men.


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