The Department of Health and Human Services is moving to make adjustments to testosterone-therapy labels, reversing changes made over a decade ago that restricted availability for some men. But with hormone drugs being hailed as yet another wellness solution, experts worry the requested adjustments by the HHS could trigger a testosterone free-for-all.
Why is the HHS asking for revisions? Since 2015, the Food and Drug Administration has required testosterone therapy labels to state that the “safety and effectiveness of the treatment had not been established” in men with symptoms associated with idiopathic hypogonadism, an age-related condition “involving low testosterone levels without a known underlying cause,” said Reuters. Now, the HHS is requesting that labels be revised to remove that statement. And after reviewing new data and evidence on the safety and benefits of hormone therapy, the department also wants to update information related to prostate cancer risk and revise warnings regarding enlarged prostates.
These updates could “pave the way for easier access to testosterone replacement therapy” for a wider subset of men, said CNN. During Men’s Health Month, the HHS is “putting science back at the center of men’s healthcare,” said HHS Secretary of Health Robert F. Kennedy Jr. in a press release.
Is testosterone therapy for everyone? No matter the outcome of the suggested revisions, experts warn that patients should still have “in-depth talks with their doctors about whether testosterone therapy could be helpful for them,” and doctors should “complete thorough evaluations,” said CNN. Besides, taking a warning off a label “isn’t the same as saying every man should be on the medication,” said Jamin Brahmbhatt, a urologist and men’s health expert at Orlando Health, to the outlet.
People have always “wanted a fountain of youth,” said Landon Trost, a urologist, to the Houston Chronicle. “Since really the 1970s or even earlier,” hormones have been considered the magical pills to achieve that goal. And today, the hormone is “widely prescribed in ways that aren’t covered by insurance,” said the outlet, and that don’t “always align with mainstream medical guidance.”
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