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.
Label Changes
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. 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. Proper diagnosis is essential before starting therapy.
Original reporting: KRDO (Colorado Springs metro) — read the source article.