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The AUA has released an updated version of its position statement on testosterone therapy.
The changes are in a response to the FDA’s March 2015 Drug Safety Communication, in which the government agency cautioned providers about using testosterone products for low testosterone due to aging or for treating symptoms in the absence of clinical disease. The FDA also requires a testosterone drug labeling change to inform patients about the possible increased risk of heart attack and stroke.
“Health care professionals should make patients aware of this possible [cardiovascular] risk when deciding whether to start or continue a patient on testosterone therapy,” according to the FDA.
The labeling change sends the message to providers and patients that those who have cardiovascular events while on testosterone should consider stopping use of testosterone, according to Ajay K. Nangia, MD, who sat in on the FDA’s hearings on testosterone therapy in September 2014, during which he presented the AUA’s then-position statement on testosterone therapy. He was among the members to revise the AUA statement.
Urologists should also take note of this change in the updated AUA position statement: “Testosterone therapy is appropriate treatment for patients with clinically significant hypogonadism, including those with idiopathic clinical hypogonadism that may or may not be age-related, after full discussion of potential adverse effects. Patients should understand that treatment requires follow-up and medical monitoring. Testosterone therapy in the absence of hypogonadism is inappropriate.”
This change is based on the FDA’s wording: “Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”
There was nothing in the FDA’s previous statement on testosterone therapy that talked about symptomatic clinical hypogonadism that was either age-related or idiopathic, said Dr. Nangia, of the University of Kansas Hospital and Medical Center, Kansas City.
“What the FDA ended up doing in the recent update was to clarify that even clinical hypogonadism that is idiopathic and/or age-related is not an indication, in and of itself, for treatment. And if you do consider that treatment, then it may well be considered off-label,” he said.
The AUA’s revised statement on testosterone therapy also tackles the issue of which testosterone therapies men should use. It notes: “Only FDA-approved medications should be used; over-the-counter preparations generally should be avoided based on lack of efficacy and safety data.”
There remain no clear positions on how to treat men with purely symptomatic clinical hypogonadism, as well as what to do with patients on testosterone who already have cardiovascular disease or risk factors, Dr. Nangia says.
“Do we get a cardiology consultation? What do [we] do with that knowledge? But that isn’t what the FDA was saying. The FDA said, just be aware the testosterone may have an effect and cause cardiovascular events. That’s even though they admitted at the hearing in September that the evidence was kind of weak. That left us in kind of a pickle. And that’s where we are,” Dr. Nangia said.
The FDA and the AUA agree that more data on cardiovascular risks of testosterone are needed.
The FDA said it is “requiring manufacturers of approved testosterone products to conduct a 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. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.”
In essence, the FDA recognizes that there is weakness in what is known and not known when it comes to treating men with testosterone therapy, according to Dr. Nangia.
Another component of the AUA’s updated statement is a call for increased federal and industry funding of testosterone therapy research, including indications, long-term benefits, and risks of current treatments of hypogonadism, as well as research to develop new and improved treatment options.
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