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FDA Set to Examine Safety and Side Effects of Testosterone Therapy

In response to two recent studies of the possible connection between testosterone therapy and an increased risk of heart attack, stroke and death, the U.S. Food and Drug Administration (FDA) has announced that it will conduct a formal assessment and report on its conclusions and potential recommendations. While the agency has not yet concluded that testosterone therapy drugs such as AndroGel, Axiron, Androdern and Fortesta do indeed cause increased danger of such side effects, its January 31, 2014 Safety Announcement urges patients to consult with their healthcare providers about whether they should continue using them.

Testosterone treatment and the impact of recent studies

An essential hormone for male grown and development, testosterone plays a vital role in the overall health of men. Though recent months and years have witnessed increased publicity campaigns and advertising for drugs intended to treat low testosterone, the FDA has only approved such drugs for use in males with actual, diagnosed medical conditions related to “low-T.” That fact has not stopped countless physicians from prescribing these treatments for men who do not necessarily have such clinical conditions, but are merely suffering from flagging energy levels, low libido and other symptoms that tend to come with age.

November of 2013 saw the publication in the Journal of the American Medical Association of an observational study of older males known to have low serum testosterone who also underwent angiography assessment for heart disease. A portion of the subjects received testosterone therapy and the others did not. The study involved men roughly 60 years of age, many of whom had underlying heart concerns. Ultimately, the report suggested that those who were given testosterone drugs had a 30 percent increase in their risk of heart attack, stroke or death.

The second study leading to the FDA’s decison to conduct further research on the effects of testosterone therapy found an elevated risk of heart attack in both older men as well as younger subjects with previous coronary concerns. The research indicated the existence of a two-fold boost in heart attack risk for men over age 65 in the initial 90 days of testosterone treatment. Younger males with existing heart issues experienced a two- to three-fold jump in their risk of heart attack during the same 90-day window.

Advocates call for stronger testosterone drug labeling

According to consumer advocates, including the watchdog group Public Citizen, testosterone side effects and risks are serious that this category of drugs should bear a so-called “black box” warning. In addition, there have been growing calls for manufacturers to do more to warn physicians about the risk of heart attacks from testosterone replacement therapy and for the FDA to postpone its decision on whether or not to approve new, long-acting, injectable testosterone drugs.

FDA evaluation of testosterone therapy drugs and concurrent heart attack risk will be ongoing, with conclusions and recommendations to be communicated by the agency at a later date. In the interim, men currently undergoing or considering beginning this type of treatment are encouraged to have honest discussions with their physicians about the possibility of a link between the medication and higher incidence of stroke and heart attack. Doctors and patients alike must conduct a balancing of the potential dangers and the potential benefits of using these drugs to address low testosterone.

  1. New York Times, New Concern About Testosterone and Heart Risks,

  2. ABC News, Group Wants Heart Attack Warning on Testosterone,

  3. FDA, Safety Announcement: FDA evaulating risk of stroke, heart attack and death with FDA-approved testosterone products,

  4. WebMD, FDA Will Review Safety of Testosterone Therapy,