The American Urological Association has published a statement on testosterone therapy after an FDA safety communication warning of potential cardiovascular risks.
The American Urological Association is an organization of medical doctors who research and treat diseases of the male urinary tract and reproductive organs. The AUA is recognized as a world leader in urology education and standards. If any organization has the expertise to issue an opinion on testosterone therapy, it is the AUA.
Until recently, however, the AUA has stayed out of the controversy surrounding the treatment of age-related testosterone decline (Low-T) with testosterone replacement drugs such as AndroGel, Testim, and Axiron. But, in August 2015, the AUA updated and published its position on testosterone therapy. The position statement follows a drug safety communication from the U.S. Food and Drug Administration (FDA) that requires manufacturers of approved testosterone information about the possibility of increased risk of heart attack and stroke to drug labels.
In their position statement, the AUA says that there is conflicting evidence about the relationship of testosterone drugs to cardiovascular risks and that additional studies are needed. The organization agrees with the FDA drug safety that benefits and risks of testosterone products for low testosterone due to aging have not been established. Therefore, the AUA says testosterone therapy is only an appropriate treatment for patients with clinically testosterone decline where the risks of low-T drugs are outweighed by the benefits. The AUA cautions that testosterone therapy is not appropriate for men with normal testosterone levels. It discourages the use of testosterone drugs for treatment of infertility, body building, performance enhancement, or other purposes not related to clinically low testosterone levels.
The AUA recommends that diagnosis of low testosterone levels include a detailed medical history, physical examination, and appropriate blood tests. The AUA emphasizes that it is important patients who are prescribed testosterone drugs be warned of adverse side effects (check also side effects of Xarelto) and receive both medical monitoring and follow-up care. The organization says that only FDA-approved medications should be prescribed and warn that over-the-counter testosterone products are often untested, unregulated, and may even be dangerous.
The AUA’s statement has been endorsed by the American Society for Men’s Health, the Sexual Medicine Society of North America and the Society for the Study of Male Reproduction.
What Does the AUA’s Statement Mean for You?
Over the past ten years, drug companies such as AbbVie and Abbot Laboratories have aggressively marketed testosterone drugs as a treatment for Low-T or age-related testosterone decline, Millions of men sought treatment for symptoms such as reduced libido, decreased energy, changes in mood, increased body fat and loss of muscle mass. These men were prescribed testosterone drugs despite the fact that the drugs were not FDA-approved for age-related testosterone decline. They were not told that use of the drugs could have potential side effects. As a result, these men were put at risk of heart attack, stroke and blood clots.
The AUA’s statement emphasizes that the potential risks associated with testosterone drugs make these medications unsuitable except in cases of clinically significant testosterone decline where the health benefits of testosterone therapy treatment outweigh the potential risks.