FDA Warns of Cardiac Risk in Elderly Testosterone Use

The U.S. Food and Drug Administration (FDA) has issued a safety announcement about the use of prescription testosterone products, emphasizing that replacement therapy is only approved in men who have low levels of the hormone due to certain medical disorders. The announcement further states that testosterone replacement therapies should not be used for treatment of low hormone levels due to aging, as the benefits and safety have not yet been evaluated. Further, information from the Advisory Committee has shown that there is a possible increased risk of heart attack, stroke or death in aging men treated with testosterone products.

The FDA is requiring manufacturers of such products to update labels to include information not only about approved uses of the medications, but also about possible cardiac risks.

Read the FDA’s announcement.

Clinical Topics: Geriatric Cardiology

Keywords: Advisory Committees, Aging, Myocardial Infarction, Risk, Stroke, Testosterone, United States Food and Drug Administration, Geriatrics

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