Safety of testosterone products being investigated by FDA

February 4, 2014

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

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

In a January 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,” FDA said.

In the most recent study published in the January issue of PLOS ONE, researchers examined the healthcare records of 55,593 men who had been prescribed testosterone therapy-48,539 under aged 65 years and 7,054 who were aged 65 years or older.

Men who were aged 65 years and older had a 2-fold increase in risk of myocardial infarction within the first 90 days after filling a prescription for testosterone therapy. In the younger group of men less than aged 65 years with pre-existing heart disease, there was a 2- to 3-fold increased risk of myocardial infarction within the 90-day window of filling the first testosterone therapy prescription. However, the younger men without a history of heart disease had no excess risk following the initial testosterone treatment, the authors noted.

"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.

An earlier study

The other study cited by FDA, which was published in JAMA last November (2013; 310:1829–1836), 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 FDA, “Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment… We urge healthcare professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.”

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