The US Department of Health and Human Services is requesting revisions to the labels on testosterone replacement therapies for men after reviewing new data and evidence on their safety and benefits. These updates could pave the way for easier access to testosterone replacement therapy.
What’s Changing
The requested label changes would include removing a statement that the safety and effectiveness of testosterone replacement therapy have not been established in men with age-related low testosterone. The agency also calls for updating information related to prostate cancer risk and revising warnings regarding enlarged prostate.
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. Although the HHS announcement reflects “science finally catching up to reality,” the government has only requested updates to testosterone therapy product labels, and no changes have been officially made yet.
Some of the concerns about testosterone therapy’s potential risks included heart problems, prostate cancer, and accelerated prostate growth. These concerns have shaped how the therapies have been labeled and prescribed. However, additional research has since emerged, including a large clinical study involving more than 5,200 men that found no “meaningful increase” in major cardiovascular events among people receiving testosterone therapy.
Expert Insights
Healthcare providers generally consider testosterone levels below 300 nanograms per deciliter of blood as low in adults. What are considered normal testosterone levels in men can range widely, from around 300 to more than 800 nanograms per deciliter, but even that depends on which guidelines are followed or which lab tests were conducted.
When prescribing testosterone, doctors look for “a level that’s genuinely low, confirmed on two separate morning blood draws when testosterone naturally peaks,” and they make sure it aligns with symptoms, such as low sex drive, fatigue, trouble with erections, or loss of muscle.
Original reporting: El Paso News (HLL/CB) — read the source article.
