FDA moves to change TRT product labeling


The FDA acted on recommendations from one of its advisory committees by requiring manufacturers of testosterone therapies to make label changes that restrict the drugs’ usage.

The FDA acted on recommendations from one of its advisory committees by requiring manufacturers of testosterone therapies to make label changes that restrict the drugs’ usage.

RELATED - Study: No increase in CV risk with testosterone

The agency is requiring all manufacturers of approved testosterone products to change their labeling to clarify that these drugs are approved only in men who have low testosterone caused by certain medical conditions and not by aging. In addition, it is requiring the addition of information to the labeling about a possible increase in cardiovascular and stroke risk in patients taking testosterone.

The announcement drew a range of reactions from physicians, including some urologists who believe testosterone products are overused but safe if prescribed appropriately.

Last fall, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee voted 20-1 to limit the prescribing of testosterone therapies to men with specific medical conditions and not those with an age-related decline in serum testosterone, the New York Times reported at the time.

That decision was criticized by Abraham Morgentaler, MD, of Men’s Health Boston and Harvard Medical School, who told Urology Times: “The vote by the FDA advisory committee in favor of revising the label on testosterone products so as to restrict their use was a step backwards for our patients and for science.”

Commenting on the FDA’s safety announcement, Dr. Morgentaler told the Wall Street Journal’s Pharmalot blog, “The decision by the FDA is bad news for men, as it will make it even more difficult for men suffering from true testosterone deficiency to be treated, and to obtain health insurance coverage for such treatment, even when medically indicated.”

READ: European agencies follow FDA lead on T, CV risk

The question of cardiovascular risks and testosterone risks remains the subject of intense debate. Dr. Morgentaler and co-authors recently published a literature review online in Mayo Clinic Proceedings (Jan. 26, 2015) that found no evidence of increased cardiovascular risk in men taking testosterone therapy. They reported that many studies included in the review found a positive correlation between “low testosterone levels and increased mortality… as well as atherosclerosis, incident coronary artery disease, and the severity of coronary artery disease,” according to a press release from Beth Israel Deaconess Medical Center, where Dr. Morgentaler is a urologist on staff.

NEXT: Drs. Kaplan, Hotaling react to announcement

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“Often, we reap what we sow. And medicine is no different,” said Steven A. Kaplan, MD, a men’s health expert at Weill Cornell Medical College and New York Presbyterian Hospital in New York. “There has been an explosion in the use of testosterone supplementation and unfortunately often in men who do not need it.

SEE: Data fail to support concerns over T therapy, CV risk

“The false promise of becoming an Adonis is simply not true. With increased use comes increased scrutiny, and the FDA warning is a prime example of this. The bottom line is that for properly selected men with vigilant follow-up, testosterone supplementation is safe and effective."

“I think a lot of people would argue that a lot of the literature suggesting increased cardiovascular risk with testosterone therapy is flawed,” said James M. Hotaling, MD, MS, a men's health expert at the University of Utah Health Care in Salt Lake City, pointing out that calls have been made for a retraction to one such study appearing in JAMA (2013; 310:1829-36).
“That probably hurt the cause for testosterone, but the other big part of it is that testosterone is getting overused in general, and it’s probably being used inappropriately in a lot of people. They’re [the FDA] looking for ways to pull it back a little bit.”

The safety announcement prompted discussion on Twitter, including these reactions from Jamin Brahmbhatt, MD, a urologist in Clermont, FL, and Mikkel Fode, MD, PhD, of the University of Copenhagen, Copenhagen, Denmark:

Testosterone overmarketing? Yes Testosterone misuse? Yes Men really need #testosterone? YES Will new FDA rule affect MEN with lowT? YES

- Dr. Jamin Brahmbhatt (@jaminbrahmbhatt) March 5, 2015

Hardly justified. Wondering about the impact: FDA orders heart-risk warning on testosterone supplements http://t.co/z7Lxu5Hx1r

- Mikkel Fode (@MikkelFode) March 5, 2015

The FDA also called for manufacturers to conduct “well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.” That drew this reaction on Twitter:

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