FDA Investigates Testosterone Therapy Side Effects

February 3, 2014 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication to announce they will investigate the risk of stroke, heart attack, and death in men on testosterone treatment products, in response to two concerning studies.

Testosterone products are commonly used to treat low testosterone in men who are aging normally. Over two-thirds of prescriptions are for a testosterone gel product called AndroGel, manufactured by AbbVie. AndroGel is marketed to treat symptoms of “Low T,” including fatigue, depression, loss of libido, and more.

However, according to the FDA, “Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”

Examples of medical conditions which testosterone therapy is FDA approved to treat include:

  • Failure of the testicles to produce testosterone due to genetic problems
  • Chemotherapy
  • Missing testicles
  • Problems with brain (hypothalmus or pituitary) resulting in little or no testosterone production in testicles.
  • Hypogonadism

The FDA cited two studies linking testosterone therapy and cardiovascular events. One study, published in the Journal of the American Medical Association (JAMA) in November 2013, suggested a 30% increased risk of stroke, heart attack, and death in a group of older men (average age 60) who were prescribed testosterone therapy.

The second study cited by the FDA reported a two-fold increased risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among men under 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack. Younger men without a history of heart disease did not have an increased risk of heart attack.

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