Early Studies See No Heart Risk From Testosterone Therapy

By Dennis Thompson HealthDay Reporter

WEDNESDAY, March 4, 2015 (HealthDay News) -- Testosterone therapy doesn't seem to increase a man's risk of heart attack or stroke, a pair of new studies suggests.

"Testosterone therapy in any form -- gel, pills or injections -- does not appear to cause adverse cardiovascular effects," said Dr. Pawan Patel, lead author of one of the studies and an academic physician at Regions Hospital in St. Paul, Minn.

The studies are to be presented next week at the American College of Cardiology (ACC) annual meeting, in San Diego. Research presented at medical meetings is typically viewed as preliminary until published in a peer-reviewed journal.

The two studies were released a day after the U.S. Food and Drug Administration issued a warning about the overuse of testosterone-boosting drugs by aging baby boomers trying to use hormone therapy to turn back the clock.

The FDA will require all prescription testosterone products to carry a warning label that cites a possible increased risk of heart attack and stroke, the agency announced Tuesday.

Patel said that, based on his research, "the FDA black box warning may be premature. We certainly need a long-term clinical trial before we put a black box warning on testosterone therapy."

Testosterone levels naturally wane as a man ages. Testosterone therapy is often used to treat the effects of low testosterone -- the "low T" cited in numerous ad campaigns. Diminished testosterone levels can have an effect on mood, memory, muscle mass, bone density and metabolism, the ACC said in a news release.

In the past five years, the use of testosterone replacement therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients in 2013, the FDA found. Nearly one in 25 men over the age of 60 receives testosterone therapy, the ACC said.

In its warning, the FDA reported 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."

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Early Studies See No Heart Risk From Testosterone Therapy