Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.
The manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, were required to include a boxed warning on the products’ labels. The agency required this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).
FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use
FDA adding general warning to testosterone products about potential for venous blood clots
FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide[ARCHIVED]
FDA News Release (5/7/2009)
AndroGel Letter: Safety Labeling Changes and Risk Evaluation and Mitigation Strategies (REMS)(PDF - 183KB)
Testim Letter: Safety Labeling Changes and Risk Evaluation and Mitigation Strategies (REMS)(PDF - 110KB)