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FDA evaluating risk of stroke, heart attack and death with FDA-approved
testosterone products
Safety Announcement
[01-31-2014] The U.S. Food and Drug Administration (FDA) is investigating the risk of
stroke, heart attack, and death in men taking FDA-approved testosterone products. We
have been monitoring this risk and decided to reassess this safety issue based on the
recent publication of two separate studies that each suggested an increased risk of
cardiovascular events among groups of men prescribed testosterone therapy. We are
providing this alert while we continue to evaluate the information from these studies and
other available data, and will communicate our final conclusions and recommendations
when the evaluation is complete.
At this time, FDA has not concluded that FDA-approved testosterone treatment increases
the risk of stroke, heart attack, or death. Patients should not stop taking prescribed
testosterone products without first discussing any questions or concerns with their health
care professionals. Health care professionals should consider whether the benefits of
FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.
The prescribing information in the drug labels of FDA-approved testosterone products
should be followed.
Testosterone is a hormone essential to the development of male growth and masculine
characteristics. 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 these conditions include failure of the testicles to produce testosterone,
because of reasons such as genetic problems or chemotherapy. Other examples include
problems with brain structures, called the hypothalamus and pituitary that control the
production of testosterone by the testicles.
None of the FDA-approved testosterone products are approved for use in men with low
testosterone levels who lack an associated medical condition. FDA-approved
testosterone formulations include the topical gel, transdermal patch, buccal system
(applied to upper gum or inner cheek), and injection.
The first publication that prompted FDA to reassess the cardiovascular safety of
testosterone therapy was an observational study of older men in the U.S. Veteran Affairs
health system published in the Journal of the American Medical Association (JAMA) in
November 2013.1 The men included in this study had low serum testosterone and were
undergoing imaging of the blood vessels of the heart, called coronary angiography, to
assess for coronary artery disease. Some of the men received testosterone treatment

while others did not. On average, the men who entered the study were about 60 years
old, and many had underlying cardiovascular disease. This study suggested a 30 percent
increased risk of stroke, heart attack, and death in the group that had been prescribed
testosterone therapy.
A second observational study reported an increased risk of heart attack in older men, as
well as in younger men with pre-existing heart disease, who filled a prescription for
testosterone therapy.2 The study reported a two-fold increase in the risk of heart attack
among men aged 65 years and older in the first 90 days following the first prescription.
Among younger men less than 65 years old with a pre-existing history of heart disease,
the study reported a two- to three-fold increased risk of heart attack in the first 90 days
following a first prescription. Younger men without a history of heart disease who filled
a prescription for testosterone, however, did not have an increased risk of heart attack.
We urge health care professionals and patients to report side effects involving
prescription testosterone products to the FDA MedWatch program, using the information
in the “Contact FDA” box at the bottom of the page.

References
1. Vigen R, O’Donnell CI, Baron AE, et al. Association of testosterone therapy with
mortality, myocardial infarction, and stroke in men with low testosterone levels.
JAMA. 2013;310(17):1829-1836.
2. DOI: 10.1371/journal.pone.0085805