FDA investigating safety of testosterone products

The FDA said it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.

In a Jan. 31 safety announcement, the agency said it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.” It also cautioned that patients “should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals.”

The investigation was prompted by the recent publication of two recent studies.

“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,” the FDA said.

In the most recent study, researchers examined the health care records of 55,593 men who had been prescribed testosterone therapy-48,539 under 65 years of age and 7,054 who were age 65 or older. They found a twofold increase in the risk of heart attack shortly after beginning testosterone therapy in men under 65 years of age and confirmed earlier findings in previous studies of a twofold increase in heart attack risk shortly after treatment began in men over 65.

"The extensive and rapidly increasing use of testosterone treatment and the evidence of risk of heart attack underscore the urgency of further large studies of the risks and the benefits of this treatment. Patients and their physicians should discuss the risk of heart attacks when considering testosterone therapy,” said senior author Sander Greenland, DrPh, of the UCLA Fielding School of Public Health.

Study results were published online in PLOS ONE (Jan. 29, 2014).

The other study cited by the FDA, which was published in JAMA (2013; 310:1829-36), evaluated the association between the use of testosterone therapy and all-cause mortality, myocardial infarction, and stroke among male veterans and whether this association was modified by underlying coronary artery disease.

The researchers, led by first author Rebecca Vigen, MD, of the University of Texas Southwestern Medical Center, Dallas, found that the proportion of patients experiencing events 3 years after coronary angiography was 19.9% in the no testosterone therapy group (average age, 64 years) and 25.7% in the testosterone therapy group (average age, 61 years), for an absolute risk difference of 5.8%.

“These findings raise concerns about the potential safety of testosterone therapy. Future studies including randomized controlled trials are needed to properly characterize the potential risks of testosterone therapy in men with comorbidities,” the authors wrote.

According to the FDA, “Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment… We urge health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.”

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