The U.S. 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.

Background

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.

According to Dr. Jamin Brahmbhatt, urologist and men’s health expert at Orlando Health in Florida, the new proposal should not make it the wild west for prescribers and patients – there still need to be guardrails in place, like for any medical therapy.

Safety Concerns

Some of the concerns about testosterone therapy’s potential risks included heart problems, prostate cancer and accelerated prostate growth. 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, such as heart attack or stroke, among people receiving testosterone therapy.

Current labels on testosterone therapy generally advise against its use in men who have known or suspected prostate cancer, and they caution that treatment may increase the risk of developing the disease. But more recent research data have not generally shown an increased risk of prostate cancer in men receiving testosterone replacement therapy.

Original reporting: Oklahoma City News Feed (HLL/CB) — read the source article.