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.

Changes to Label Warnings

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.

Benefits and Risks of Testosterone Therapy

Testosterone therapy has proven benefits for specific symptoms, such as improved libido, sexual function, correction of anemia, and modest improvements in mood and energy. However, potential risks and side effects may include skin reactions, acne, enlargement of male breast tissue, pulmonary embolism or blood clots, irregular heart rhythms, suppression of sperm production, and minimal increase in blood pressure.

Healthcare providers generally consider testosterone levels below 300 nanograms per deciliter of blood as low in adults. When prescribing testosterone, doctors look for a level that’s genuinely low, confirmed on two separate morning blood draws when testosterone naturally peaks, and aligns with symptoms such as low sex drive, fatigue, trouble with erections, or loss of muscle.

Original reporting: KTVZ (Central Oregon) — read the source article.