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, reports BritPanorama.
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, HHS announced Thursday.
Additionally, the agency calls for updating information related to prostate cancer risk and revising warnings regarding enlarged prostate.
“By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men,” HHS Secretary Robert F. Kennedy Jr. said in the announcement.
Experts warn that patients should still have in-depth talks with their doctors about whether testosterone therapy could be beneficial for them, emphasizing the necessity for thorough evaluations.
Although the HHS announcement reflects “science finally catching up to reality,” the government has only requested updates to testosterone therapy product labels, with no changes made officially yet, noted Dr. Jamin Brahmbhatt, a urologist and men’s health expert. “And taking a warning off a label isn’t the same as saying every man should be on it,” he cautioned.
“Testosterone is still a medical therapy, not a wellness drug. This new proposal should not make it the wild wild west for prescribers and patients – there still need to be guardrails in place, like for any medical therapy,” he added, expressing hope that clearer labels might enable more insurers to cover therapies for the men who truly need them.
A new look at the safety
Some of the concerns about testosterone therapy’s potential risks included heart problems, prostate cancer, and accelerated prostate growth. These concerns have historically shaped how the therapies have been labeled and prescribed.
Heart risks
In 2015, the US Food and Drug Administration required label changes on testosterone therapy, stating that the safety and effectiveness had not been established for men exhibiting signs and symptoms associated with idiopathic hypogonadism, a condition involving low testosterone levels. This limitation was added because of limited evidence of benefit and concerns raised about possible cardiovascular risks, according to HHS.
However, additional research has since emerged, including a large clinical study involving more than 5,200 men, which found no “meaningful increase” in major cardiovascular events, such as heart attack or stroke, among those receiving testosterone therapy.
Cancer concerns
HHS has noted the evolving scientific perspective on prostate cancer risks linked to testosterone therapy. Current labels generally advise against its use in men with known or suspected prostate cancer and caution that treatment may increase the risk of developing the disease.
Nonetheless, more recent research data suggest there is generally no increased risk of prostate cancer in men receiving testosterone replacement therapy, according to the agency. Under the requested revisions, therapy would be advised against only in men whose prostate cancer has metastasized.
Enlarged prostate
Current labels on therapies warn that testosterone therapy may worsen symptoms of benign enlarged prostate; however, HHS indicated that a new FDA review found no evidence of aggravation in men with mild to moderate symptoms. For men experiencing more severe symptoms, evidence remains limited, and the labeling changes requested would recommend continued monitoring during treatment.
The new HHS request to change the language on labels “removes the fear” around testosterone replacement therapy, said Dr. Eddie Hackler III, an Atlanta-based cardiologist. “Testosterone therapy has proven benefits for specific symptoms, particularly improved libido, sexual function, correction of anemia, and modest improvements in mood and energy. Proper diagnosis is essential before starting therapy,” he emphasized.
He also noted that testosterone therapy does not appear to increase the risk of heart attacks, strokes, or prostate cancer based on the best available randomized trial data. Potential risks and side effects could still include skin reactions, acne, enlargement of male breast tissue, complications like pulmonary embolism or blood clots, irregular heart rhythms, suppression of sperm production, and a minimal increase in blood pressure.
‘A long time coming’
The new move by HHS is the latest in ongoing efforts to reduce restrictions on hormone therapies. Last year, similar steps were taken regarding hormone therapy for women when the FDA removed “black box” warnings from menopausal hormone therapy products.
In December, the FDA hosted an expert panel discussion on testosterone replacement therapy for men, after which the agency has been investigating potential new treatment options involving testosterone.
Dr. Adam Baumgarten, an associate professor at the University of Alabama at Birmingham, remarked that the request to change warning labels on testosterone therapy has been “a long time coming.” He noted, “The first major takeaway is that the cardiovascular safety concerns that have surrounded testosterone therapy for the past decade are no longer supported by randomized trial data.”
Baumgarten added that the FDA has meaningfully narrowed its prostate cancer warning and affirmed that ongoing monitoring with proper lab follow-up remains necessary for men on testosterone therapy. “At the same time, it is widely recognized that normal testosterone levels vary with age and are not defined by a single fixed value for all men,” he concluded.
