FDA issues new labeling indications for testosterone replacement therapy

March 4, 2015

FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.

FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.

The safety announcement from FDA makes clear that these products are approved strictly for men with low levels of testosterone resulting from specific medical conditions that have been confirmed by laboratory tests. All manufacturers of TRT prescription products are now required to change labeling to correctly reflect these medications’ approved uses. Further, TRT product manufacturers are required to explain in the product labeling about the possible increased risk of myocardial infarction (MI) and stroke for patients on TRT.

Related:Safety of testosterone products being investigated by FDA

The FDA safety announcement states that TRT is only approved for men with low levels of testosterone caused by disorders leading to hypogonadism, including disorders of the brain, pituitary gland, or the testicles. FDA provides specific examples of these disorders, such as genetic problems or damage from infection or chemotherapy that has resulted in the failure of the testicles to produce testosterone.

This safety announcement has been made against the backdrop of TRT being prescribed to try to relieve symptoms in those with low testosterone that occurs because of aging. Multi-district litigation in Chicago has also been undertaken against TRT manufacturers regarding serious injuries claimed to have resulted from such use. Neither safety nor realized benefits have been established for treating these men who have aging-related low testosterone with TRT.

FDA is requiring TRT manufacturers to undertake a clinical trial designed to address if there exists an increased risk of MI or stroke among patients using TRT products. TRT manufacturers may either join together in this effort or conduct trials separately.

Finally, FDA cautions men using TRT to immediately seek medical attention if they experience symptoms including chest pain, shortness of breath or difficulty breathing, weakness in one side or part of the body, and/or slurred speech.