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FDA Warning

FDA Warning

The physicians at West Alabama Urology Associates would like to make our patients aware of recent important findings regarding the treatment of low testosterone (hypogonadism) in men.

Hypogonadism is a medical condition consisting of low blood levels of the male hormone testosterone and symptoms including low energy, depressed mood, sleep disturbances, depressed cognition, impotence (problems with erections), and low libido (poor sexual drive). Low testosterone may also unknowingly contribute to systemic disease including diabetes, high blood pressure, cardiovascular risk, and osteoporosis. Diagnosis of hypogonadism is performed by a performing a thorough history and physical and testing blood samples for testosterone level.

Men undergoing treatment for low testosterone usually demonstrate an improvement in blood testosterone levels and in energy levels, lean muscle mass, mood and cognition, and sexual performance. Multiple studies of men receiving testosterone supplementation have also demonstrated improvement of medical conditions including better blood sugar control in diabetics, less cardiovascular risk factors, less risk for depression, improved bone density and overall better life expectancy.

However, two recent studies published in the New England Journal of Medicine and the Journal of the American Medical Association has challenged the safety of testosterone supplementation in men. These studies suggested an increase in the risk of heart attack and stroke in the population of men receiving testosterone therapy. Although there are questions regarding the validity of the results for the general population, we in the medical community are aware and want to inform you, our patients, of these findings. Please note, in many incidences the benefits of testosterone therapy outweigh potential risks and we await better randomized studies to conclusively tell if risks are present. Given these findings, the FDA recently released the following recommendation.

“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. We are 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.

In addition, 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.

Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.

Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as:

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech

Full information regarding the FDA position can be found at the FDA website:

If you have any questions regarding your treatment, please do not hesitate to speak with your physician. We pledge to keep you informed and provide the best care possible for our patients.