FDA Updates Testosterone Heart Attack, Stroke WarningsMarch 4, 2015 — The FDA has issued a Safety Communication to warn about the risk of heart attacks and strokes from testosterone replacement products, such as AndroGel.

The FDA is also requiring manufacturers to change their labeling to clarify that testosterone products are not approved for low testosterone due to aging.

According to the FDA:

“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.”

Forbes put it more bluntly: “Stop wooing the average guy who has a sagging libido and fatigue simply because he’s aging.”

Testosterone therapy is only FDA-approved for hypogonadism, or low testosterone due to a medical condition like an infection, genetic problems, chemotherapy, or pituitary gland problems.

Drug-makers are not allowed to market their products for unapproved purposes, but only half of men on testosterone actually had hypogonadism, and 25% never even had their hormone levels tested.

Many of those men talked to their doctor about testosterone therapy after viewing ubiquitous TV ads for “Low T,” featuring middle-aged men complaining of symptoms that anyone over 50 has occasionally — fatigue, moodiness, loss of libido, and more. Sales skyrocketed from 1.3 million in 2009 to 2.3 million in 2013.

Unfortunately, no one knows the long-term risks of testosterone replacement therapy. The FDA is now requiring testosterone drug-makers to conduct clinical trials to better understand the potential cardiovascular risks.

The FDA reviewed five studies and two meta-analyses, which found conflicting results. Of the two studies that found evidence of a risk, one study (Vigen) found a 30% increased rate of heart attack, stroke, and death associated with testosterone. The other study (Finkle) found an increased risk of heart attack in the 90 days following an initial prescription for testosterone.

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