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FDA Investigates Testosterone Therapy Side Effects


February 3, 2014 — In a Safety Communication, the U.S. Food and Drug Administration (FDA) says it will check into the cardiovascular safety of testosterone treatment products after two studies published in the last three months found concerning evidence of stroke, heart attack, and death.

The FDA also emphasized that testosterone treatment products are only approved for use in men with low testosterone and an associated medical condition. Examples of medical conditions meeting FDA criteria include:

  • Hypogonadism
  • Genetic condition causing testicles to fail to produce testosterone
  • Chemotherapy
  • Missing or damaged testicles
  • Failure of testicles to produce testosterone
  • Brain disorders (pituitary or hypothalmus) resulting in low testosterone in testicles.

The FDA cited two concerning studies linking testosterone therapy and heart problems:

  • Journal of the American Medical Association (JAMA), November 2013, published a study linking testosterone therapy to a 30% increased risk of heart attack, stroke, and death in older men (average age 60).
  • PLoS One, January 2014, published a study reporting a doubled increased risk of heart attack among men older than 65 during the first 90 days of treatment. Researchers also found a two- to three-fold increased risk of heart attack among men under 65 who had a previous diagnosis of heart disease. Men under 65 without heart disease had no increased risk. Click here to read more.

In recent years, over 5 million prescriptions have been written for testosterone treatment products, though only 50% actually have an associated medical condition like hypogonadism. Over two-thirds of prescriptions were written for AndroGel, a topical testosterone gel that is rubbed into the shoulders and upper-arms.

AndroGel is aggressively marketed by AbbVie as a way to treat symptoms of “Low T,” including fatigue, low libido, depression, sagging muscles, and more. These symptoms normally occur as a result of natural decreases in testosterone (1-2% per year) after age 40.

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