SAFETY ANNOUNCEMENT – FDA is evaluating
risk of stroke, heart attack and death with FDA-approved Testosterone products
[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.
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
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