At FOMAT, endocrine research includes studies that examine hormone therapies and their real-world safety profiles across diverse patient populations. The regulatory debate around testosterone therapy is a strong example of why rigorous clinical trial data matters \u2014 and why post-market safety studies are just as important as initial approvals. As a clinical research organization, we follow FDA reviews like this one closely because they shape how future trials are designed and who gets included. Here’s what the FDA found in its review of testosterone therapy risks and benefits:<\/p>\n
The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious testosterone therapy risks.<\/p>\n
The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the male hormone. Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testosterone therapy and heart problems in men.<\/p>\n
\u00a0The scrutiny comes amid an industry marketing blitz for new pills, patches and formulations that has transformed testosterone a multibillion-dollar market. Advertisements for prescription gels like Fortesta and Androgel promise aging men relief from “Low-T,” a condition they link to low libido, fatigue and weight gain.<\/p>\n
\u00a0But FDA reviewers state that “the need to replace testosterone in these older men remains debatable.” While testosterone levels naturally decline after age 40, it’s unclear whether those lower levels actually lead to the signs commonly associated with aging, including decreased energy and loss of muscle.<\/p>\n
\u00a0The FDA first approved testosterone injections in the 1950s for men who had been diagnosed with hypogonadism, a form of abnormally low testosterone caused by injury or medical illness.<\/p>\n
\u00a0But the recent advertising push is focused on otherwise healthy men who simply have lower-than-normal levels of testosterone.<\/p>\n
\u00a0The FDA memo calls testosterone use in these patients “controversial” and notes that “there are no reliable data on the benefit in such a population.”<\/p>\n
\u00a0The agency will ask its panel of outside experts this month whether the prescribing information on testosterone drugs should be revised to focus on a narrower group of patients.<\/p>\n
\u00a0The panelists will also be asked to weigh in on two recent studies that showed higher rates of cardiovascular problems in men using testosterone. A U.S. Veterans Affairs study published in November 2013 showed a 30 percent increase in stroke, heart attack and death among older men taking testosterone. In January, another federally funded study of 45,000 men with an existing heart condition suggested testosterone therapy could double the risk of heart attacks in men 65 and older.<\/p>\n
\u00a0But in its review, the FDA notes that two other studies have associated testosterone with longevity. According to the agency review, the available studies “do not provide convincing evidence that testosterone replacement therapy is associated with adverse cardiovascular events.” [\u2026]<\/p>\n","protected":false},"excerpt":{"rendered":"
En FOMAT, la investigaci\u00f3n endocrina incluye estudios que analizan las terapias hormonales y sus perfiles de seguridad en la pr\u00e1ctica cl\u00ednica en diversas poblaciones de pacientes. El debate regulatorio en torno a la terapia con testosterona es un claro ejemplo de por qu\u00e9 son importantes los datos rigurosos de los ensayos cl\u00ednicos, y por qu\u00e9 la seguridad poscomercializaci\u00f3n\u2026<\/p>","protected":false},"author":3,"featured_media":21186,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[968],"tags":[999,971,1065],"class_list":["post-3059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogs-updates","tag-drugs","tag-fda","tag-pharma"],"acf":[],"_links":{"self":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/3059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/comments?post=3059"}],"version-history":[{"count":1,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/3059\/revisions"}],"predecessor-version":[{"id":73126,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/posts\/3059\/revisions\/73126"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media\/21186"}],"wp:attachment":[{"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/media?parent=3059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/categories?post=3059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fomatmedical.com\/es\/wp-json\/wp\/v2\/tags?post=3059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}