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.
A diagnosis of hypogonadism requires laboratory evidence of low testosterone levels measured on at least two separate mornings. However, in one health plan database, approximately 20 percent of men who received testosterone prescriptions had no insurance claims for laboratory testing of testosterone levels.
FDA has approved testosterone products to replace testosterone in men who have low testosterone levels associated with certain medical conditions. Examples of these conditions include:
In the past 5 years, the use of testosterone replacement therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients in 2013 receiving a prescription for a testosterone product. Currently, approximately 70 percent of men who receive testosterone prescriptions through retail pharmacies are between 40 and 64 years old. The most common diagnostic code associated with testosterone therapy is the non-specific diagnosis of “testicular hypofunction, not elsewhere classified.”
FDA-approved testosterone formulations include gels, solution, skin patch, intramuscular injection, pellets implanted under the skin, and a buccal system applied to the upper gum or inner cheek.
The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. The FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.
Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.
Based on the available evidence from published studies and expert input from an Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.
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).
Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as: