This is T-rrific news for some men.
Testosterone replacement therapy (TRT) has been historically difficult to get because it requires proof of consistently low testosterone levels along with symptoms like fatigue, low libido or erectile dysfunction that’s not just from aging.
Now, a US Food and Drug Administration panel is recommending loosening testosterone restrictions by declassifying these meds as controlled substances and updating their labels to expand access for men with age-related low testosterone.
“Testosterone deficiency negatively impacts health, reduces quality of life [and] increases the risk for mortality,” Dr. Mohit Khera, a professor of urology at Baylor College of Medicine, said at Wednesday’s panel discussion, per Urology Times.
“Testosterone therapy offers multiple clinical benefits, such as improvements in diabetes, obesity and bone mineral density.”
Testosterone is crucial for men — and women — since it affects muscle and bone health, mood, energy and cognitive function by regulating metabolism, libido and red blood cell production.
Levels are much higher in men, as testosterone also contributes to a deep voice, facial and body hair and sperm production.
Unfortunately, male testosterone levels naturally and gradually decline by about 1% per year after the age of 30.
Testosterone can also decrease due to excess body fat, which promotes the conversion of testosterone to estrogen, and chronic conditions like diabetes and liver disease that impair testosterone production.
The FDA has approved TRT, as gels, patches, injections and implantable pellets, for men with medically diagnosed low testosterone from testicular, pituitary or brain issues. It’s not approved for “age-related” low T without an underlying cause.
“The narrow FDA labeling makes it so that only a minority of men who could benefit from treatment are considered ‘on-label’ treatment, and many physicians are reluctant to prescribe in an off-label manner,” Dr. Bobby Najari, a urologist and men’s sexual and reproductive health specialist at NYU Langone Health, told The Post.
These restrictions have given rise to online TRT clinics and cash-based centers marketing testosterone as a fountain of youth that can boost energy, libido and muscles.
But there’s no strong scientific evidence that testosterone can slow or reverse the overall aging process.
One of the reasons that testosterone has been so tough to get is that it has been classified as a Schedule III controlled substance since 1990 due to concerns that athletes would misuse it to enhance their performance.
Ketamine and anabolic steroids are among the other Schedule III controlled substances.
“Because it is a controlled substance, there are barriers to prescribing,” said Najari, who was not part of Wednesday’s FDA talk.
“In New York, I have to look up every patient I prescribe TRT to on a state website to see if they are getting testosterone from any other prescriber,” he added. “I also can’t prescribe refills. The administrative burdens limit the number of prescribers who have the resources to care for these patients.”
Historically, there have also been major concerns that TRT increases the risk of prostate cancer, heart attack and stroke.
But recent large-scale studies have found TRT to be generally safe for the heart, without significantly raising prostate cancer risk.
“Providers and patients have been reluctant to try therapy based on outdated concerns about its safety,” said Najari.
The new data prompted the FDA to update the labeling of testosterone products this year to remove the cardiovascular risk warning and add a new warning about increased blood pressure, calling for monitoring and caution for uncontrolled hypertension.
Wednesday’s FDA panel is part of a new series of roundtable discussions of experts re-evaluating scientific evidence on various topics.
A recent FDA panel on hormone replacement therapy for menopausal women led to the agency removing most black box warnings from these therapies.
