FDA to Review Safety of Testosterone Therapy

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Harvard Medical School
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FDA to Review Safety of Testosterone Therapy

News Review From Harvard Medical School

February 3, 2014

News Review From Harvard Medical School -- FDA to Review Safety of Testosterone Therapy

Drug regulators will review the safety of testosterone treatments because of research suggesting that they may raise heart risk for some men. The U.S. Food and Drug Administration (FDA) announced the review January 31. Testosterone has been widely advertised as a potential treatment for low energy and sex drive, among other symptoms. But a study published January 29 found an increased risk of heart attack for men taking testosterone therapy. The risk was seen among men under age 65 with prior heart disease and older men with or without heart disease. Heart attack risk doubled in the 90 days after the men began treatment. The journal PLoS One published the study online. A study in 2010 also found a higher risk of heart problems in men taking testosterone. All were over 65. They were compared with men who received placebo treatments. The new study used a medical records database. It was the first to look at risk in men under age 65. The FDA said it had not yet reached any conclusions about the heart-related risks of testosterone. But it urged doctors to consider both risks and benefits before prescribing testosterone. HealthDay News wrote about the announcement February 2.


By Howard LeWine, M.D.
Harvard Medical School


What Is the Doctor's Reaction?

Testosterone therapy is more popular than ever. Global sales are expected to reach $5 billion by 2017. The hormone is promoted as a potential way for men to reverse the clock by improving energy, mood and sex drive.

After age 30, a man's testosterone level begins falling about 1% per year. So by age 70, a man on average produces about half as much as he did in his 20s. But for most men, that level is still enough to maintain general health and sexual function.

That's why it's hard to define what low testosterone (popularly called "low T") means. Hormone levels fall in every man as he ages.

When testosterone levels are clearly in the very low range, replacement therapy:

  • Helps keep bones strong
  • Prevents muscle wasting
  • Can help improve sexual function

However, most testosterone gels, patches and shots are now being prescribed for men to treat symptoms that doctors previously attributed to a natural aging process.

The dilemma is that the symptoms of low T can be caused by many other conditions as well. These symptoms include having low energy, feeling down and having less interest in sex. If testosterone therapy had no side effects, a trial of this treatment might be reasonable after your doctor had evaluated other potential causes of your symptoms.

However, a new study and a couple of studies before this latest one suggest that testosterone therapy may have significant side effects. Older, healthier men and younger men with known heart disease may have a two to three times higher risk of a heart attack, stroke and early death from testosterone therapy.

The Food and Drug Administration (FDA) is taking this seriously. The agency has been aware of potential health risks and has been tracking results of studies. Now the FDA is launching a more thorough investigation.


What Changes Can I Make Now?

If you are wondering about whether testosterone therapy might help you, first ask yourself a few questions:

  • Have you considered other reasons for the fatigue, low sex drive, and other symptoms that may be attributable to low testosterone? For example, do you eat a balanced, nutritious diet? Do you exercise regularly? Do you sleep well? Address these factors before turning to hormone therapy.
  • If your sex life is not what it used to be, could relationship or psychological issues be having an effect?
  • If erectile dysfunction has caused you to suspect "low T" as the culprit, consider first whether the problem is related to poor circulation.

If you want to go ahead with testosterone treatment, make sure you get an accurate reading on your level of this hormone. The blood test should be done between 7 a.m. and 10 a.m., when testosterone is at its peak. Confirm a low reading with a second test on a different day.

After starting therapy, follow up with your doctor to have regular testosterone checks. Other lab tests also are needed to make sure the therapy is not causing any problems.

Be mindful of the possible risks of heart attack and stroke. Testosterone therapy can increase the size of the prostate in some men and cause problems with urinating. The risk of prostate cancer from testosterone treatment also remains unanswered.

Have realistic expectations. Any improvements in energy, strength, mood or "get up and go" may be subtle. And if erectile function has been a problem, testosterone therapy might not fix it. In fact, it might increase your sex drive but not allow you to act on it. You may need other therapy.


What Can I Expect Looking to the Future?

Testosterone products have been widely advertised and promoted to the general public. The FDA is correct to embark on a more thorough investigation of the potential very serious risks. More studies likely will be needed to get more definitive answers.


Last updated February 03, 2014

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