March 4, 2015 — The FDA is asking manufacturers of prescription testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks.
In a Safety Communication issued yesterday, the agency warned:
“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.”
It is normal for men over 50 to have lower testosterone levels than young, healthy men. It is also normal for older men to occasionally have fatigue, low sex drive, moodiness, increased body fat, less muscle mass, and other ailments.
The most popular testosterone products, such as AndroGel, were marketed with a ubiquitous ad campaign suggesting that these ailments could be symptoms of “Low T,” encouraging men to talk to their doctor. Between 2009 and 2013, prescriptions for testosterone skyrocketed from 1.3 million to 2.3 million.
Federal law prohibits marketing drugs for “off-label” (unapproved) purposes. However, only 50% of men on testosterone therapy actually have hypogonadism, which is the only condition the FDA has approved the drugs to treat.
Hypogonadism involves low testosterone due to a medical condition, such as missing testicles, pituitary gland problems, chemotherapy side effects, infections, and more.
One major reason “off-label” marketing is prohibited is because long-term side effects have not been studied. Now, the FDA is demanding that drug-makers conduct new clinical trials to assess potential cardiovascular side effects of testosterone therapy.
At least two studies have already found evidence of a risk. One study (Vigen) found a 30% higher risk of heart attack, stroke, and death. Another study (Finkle) found higher rates of heart attack in the 90 days after an initial prescription for testosterone.