A Food and Drug Administration panel on Wednesday advocated for regulatory changes that would make testosterone medications more widely accessible, including removing their classification as controlled substances and changing product labels to expand eligibility.
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The 13-person panel \u2014 composed primarily of urologists and federal health officials \u2014 gave a resounding endorsement of testosterone replacement therapy, a treatment for men whose bodies don\u2019t produce enough of the hormone. The experts said the therapy, known informally as TRT, has been underutilized due to outdated concerns about risks of prostate cancer, stroke and heart disease.<\/p>\n
\u201cTestosterone is still regulated as if it were a dangerous, performance-enhancing drug from the athletic doping scandals of the 1980s. And because of this outdated classification, many physicians fear prescribing it or even screening for it,\u201d said Dr. Helen Bernie, an associate professor of urology at the Indiana University School of Medicine, who was one of the panelists.<\/p>\n
The panel was part of a series that the FDA rolled out earlier this year. In each, the agency convenes medical experts for roundtable discussions that can give clues about regulatory changes the FDA might pursue. Three months after a similar panel on hormone replacement therapy for menopausal women, for example, the FDA announced that it was removing a black box warning from the medications. On Wednesday, several panelists suggested that the FDA should expand its approval of TRT drugs to include men with low testosterone levels and any related symptoms, in accordance with guidelines from the American Urological Association.<\/p>\n
So far, the FDA has only approved forms of TRT \u2014 including gels, pills, patches and injections \u2014 for men who have both low testosterone and an associated medical condition, such as a genetic disorder that prevents the testicles from producing the hormone. \u201cGiven the label restriction, one can make the argument that thousands of patients in need of testosterone therapy have been and are being deprived of it,\u201d said Dr. John Mulhall, a panelist and urologic surgeon at Memorial Sloan Kettering Cancer Center.<\/p>\n
Testosterone therapy has soared in popularity in the last five or so years \u2014 in large part among young men who have turned to it for unapproved uses such as increasing muscle mass. The medication is widely promoted on social media for this purpose. \u201cIt\u2019s not that there is an increase in the prevalence of testosterone deficiency,\u201d said Dr. Bobby Najari, a urologist at NYU Langone Health, who was not part of Wednesday\u2019s discussion. \u201cI think it\u2019s an increase in the demand for a drug that can make it easier to have physiques that we see in superhero movies.\u201d<\/p>\n
Some wellness clinics and \u201clongevity centers\u201d also offer TRT as a purported way to slow the effects of aging, though the FDA has not approved it for that purpose. The agency cautioned in February that the safety and benefits of this use have not been established. Now-Health Secretary Robert F. Kennedy Jr. told Newsmax in 2023 that he was taking testosterone replacement at the time as part of an \u201canti-aging protocol.\u201d<\/p>\n
Typically, men\u2019s testosterone levels decline about 1% per year starting in their 30s or 40s. Levels aren\u2019t considered low until they reach a certain threshold. After that point, some men experience short-term symptoms such as fatigue, low sex drive and erectile dysfunction, as well as long-term ones like osteoporosis.<\/p>\n
The panel included little discussion of the drawbacks of TRT, such as an elevated risk of blood clots. TRT can also shut down sperm production, so doctors don\u2019t recommend it to men trying to have children. \u201cIf they take it long enough, and they\u2019re rendered infertile, it may not be reversible,\u201d said Dr. Marc Goldstein, surgeon-in-chief of male reproductive medicine and surgery at Weill Cornell Medicine, who wasn\u2019t on the panel.<\/p>\n
Not all cases of low testosterone need to be treated with TRT, he added \u2014 some can be addressed through weight loss or an outpatient surgery to remove swollen veins in the scrotum called varicoceles. Najari, meanwhile, said it\u2019s essential to manage expectations about how much TRT can do. \u201cA small group of men don\u2019t feel any change at all,\u201d he said. \u201cOn the other end of that curve, a small group of men say, \u2018I feel so much better. This really changed my life.\u2019 And then the majority of men say, \u2018I feel a little bit better.\u2019\u201d<\/p>\n
The panelists on Wednesday argued that the Drug Enforcement Administration should remove its designation of testosterone as a Schedule 3 drug \u2014 the same category that the drug ketamine is in. Dr. Landon Trost, a panelist and the director of the Male Fertility and Peyronie\u2019s Clinic in Orem, Utah, said that because prescriptions for Schedule 3 drugs must be carefully tracked, physicians may be hesitant to give them and some pharmacies may choose not to carry the drugs or limit their volume.<\/p>\n
The FDA says the broader goal of these panels is to \u201cmodernize regulatory oversight,\u201d but some public health experts have criticized them for not incorporating a diversity of viewpoints or thoroughly screening panelists for conflicts of interest. Some experts have also expressed concern that the format may be taking the place of a more formal review process and that panelists are picked to support changes that Kennedy favors.<\/p>\n
In conclusion, the FDA panel’s recommendations to loosen restrictions on testosterone replacement therapy could have significant implications for men’s health. While there are potential benefits to TRT, it is essential to carefully weigh these against the potential risks and to ensure that the therapy is used responsibly and under the guidance of a qualified healthcare professional.<\/p>\n
Testosterone replacement therapy (TRT) is a treatment for men whose bodies don\u2019t produce enough testosterone.<\/p>\n
The benefits of TRT include improved energy levels, increased sex drive, and enhanced overall well-being.<\/p>\n
The risks of TRT include an elevated risk of blood clots, infertility, and potential interactions with other medications.<\/p>\n
Men with low testosterone levels and related symptoms, such as fatigue, low sex drive, and erectile dysfunction, may be eligible for TRT.<\/p>\n
TRT can be administered through gels, pills, patches, or injections.<\/p>\n","protected":false},"excerpt":{"rendered":"
Introduction to Testosterone Replacement Therapy A Food and Drug Administration panel on Wednesday advocated for regulatory changes that would make testosterone medications more widely accessible, including removing their classification as controlled substances and changing product labels to expand eligibility. The Panel’s Recommendations The 13-person panel \u2014 composed primarily of urologists and federal health officials \u2014 […]<\/p>\n","protected":false},"author":4,"featured_media":23472,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rank_math_lock_modified_date":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[22],"tags":[],"class_list":{"0":"post-23470","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-wellness"},"jetpack_featured_media_url":"https:\/\/i3.wp.com\/media.nbcmiami.com\/2025\/12\/GettyImages-143490387.jpg?quality=85&strip=all&fit=3000,1996&w=1920&resize=1920,1277&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/posts\/23470"}],"collection":[{"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/comments?post=23470"}],"version-history":[{"count":1,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/posts\/23470\/revisions"}],"predecessor-version":[{"id":23473,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/posts\/23470\/revisions\/23473"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/media\/23472"}],"wp:attachment":[{"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/media?parent=23470"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/categories?post=23470"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/citystuff.com\/miami\/wp-json\/wp\/v2\/tags?post=23470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}