Testosterone Therapy Linked to Heart Risks

If you’re thinking about trying testosterone therapy to boost your energy or restore a little lost “drive,” consider this: Research has linked low T therapy to an increased risk of heart attack, stroke and death.

Related: Learn more about low T.

After two key studies suggested the risks, the FDA announced in a press release that it is investigating the safety of the drugs. The first study, published in The Journal of the American Medical Association in November 2013, analyzed U.S. Veterans Affairs data and concluded that veterans around the age of 60 who received testosterone therapy had a 30% higher risk of heart attack, stroke and death. The second study, published in January 2014 in PLOS One, found that the risk of heart attack and stroke doubled in the first 90 days that older men used low T therapy. In younger men with pre-existing heart disease, the risk tripled in the first 90 days of use.

But doesn't low T cause heart disease?
Maybe so. In a review published in the Journal of Clinical Endocrinology & Metabolism in 2013, researchers evaluated studies dating back to 1970 that dealt with the relationship between testosterone and cardiovascular disease in men. And they concluded that men with low T may have a slightly higher risk of developing or dying from heart disease. But the finding came with caveats. The review could not fully link low-T with atherosclerosis (hardening of the arteries), nor did it show that low T increases a man's risk of heart attack. And researchers also found that treating low T with testosterone replacement had no positive effect on a man's heart health. The researchers said more study is needed to sort out the connection.

Related: Visit the low T topic center for more information.

Are low T drugs overused?
One thing is clear: Low T treatment is booming, with prescriptions having tripled since 2001 and sales expected to increase 250% between 2012 and 2017. Some experts are concerned that many men may be taking the drugs unnecessarily; in a quarter of cases, doctors are writing prescriptions without even checking men’s testosterone levels first. In its statement, the FDA pointed out that the drugs are approved only for use in men with certain medical conditions that reduce testosterone production—not for the normal slowdown men experience with aging.

Talk to your doctor
The FDA didn’t say when their investigation (which applies to testosterone topical gel, transdermal patch, a buccal system and injections) will be complete. In the meantime, the agency doesn’t advise men to stop taking their testosterone medicines, but it does encourage them to discuss all concerns with their doctors. Even more importantly, doctors should also think about whether the benefits of testosterone treatment outweigh the associated risks, according the release. The FDA has also asked doctors who prescribe testosterone treatment -- and the men who take it -- to report any adverse effects to its MedWatch program.