Testosterone Replacement Therapy

On January 31st, 2014, the FDA issued an alert stating it would be examining the risk of stroke, heart attack and death in men using FDA-approved testosterone products such as AndroGel and Testim.  The FDA decided to reassess the safety of testosterone products based upon the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

Testosterone is a hormone essential to the development of male growth and masculine characteristics.  Testosterone therapy is designed to help men combat the natural decline in testosterone levels as they age.  Otherwise known as “low T therapy,” it helps to increase testosterone levels, increase muscle mass and bone density, reduce body fat and improve sex drive

Recent studies have linked prescription testosterone use with an increased risk of heart attacks, strokes and death.  In November 2013, the Journal of the American Medical Association (JAMA) published an observational study of older men in the U.S. Veteran Affairs health system.  The men included in this study had low serum testosterone and were undergoing imaging of blood vessels of the heart to assess coronary artery 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 published in January 2014 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 men less than 65 years of age 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 the first prescription.

Wilentz is currently investigating potential legal claims for men who suffered a heart attack, stroke or death while taking prescription testosterone therapy.  If you believe that you or a loved one has been injured due to the use of testosterone replacement products please call us at 866-613-9319 or fill out this free attorney consultation form.

Additional Information:

FDA Drug Safety Announcement for Testosterone Products

Increased Risk of Non-Fatal Myocardial Infarction

Association of Testosterone Therapy with Mortality

Mass tort and product liability litigation


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