Testosterone therapy manufacturers must update the labels of all testosterone products to inform men about the increased risk of stroke, heart attack and death in patients taking testosterone, according to a testosterone safety announcement issued by the U.S. Food & Drug Administration (FDA) earlier this week.
“The benefit and safety of testosterone have not been established in men who have low testosterone levels for no reason other than age,” according to the FDA warning.
Between 2001 and 2011, The Journal of the American Medical Association reported that the use of hormones in men over 40 increased by almost 360 percent. This may have been due to an overwhelming amount of advertising about the inappropriate use of testosterone drugs, including consumer ads that promised aging men renewed vitality and strength.
A variety of factors can influence testosterone levels. However, testosterone therapy is only approved by the FDA for men who have low testosterone levels due to a disorder of the testicles, pituitary gland or brain that cause a condition called hypogonadism.
A recent FDA analysis showed that only about half of men taking testosterone therapy have been officially diagnosed with hypogonadism. This means many men are being prescribed hormones without a clear indication for its use, and are being unnecessarily put at risk for serious cardiovascular side effects.
The FDA has concluded, based on available evidence from published testosterone studies, there is a possible increased risk of heart attack and stroke. As a result, the organization is requiring testosterone therapy manufacturers to conduct additional clinical trials to better establish the risks of testosterone treatments.
Testosterone treatment lawsuits are now being filed by men who took testosterone and suffered strokes or heart attacks. If you or your loved one was harmed as a result of taking testosterone for an unapproved FDA use, you may have legal rights.
Simmons Hanly Conroy attorney Trent Miracle is the co-lead attorney for the national testosterone replacement therapy litigation and may be able to help you enforce your legal rights.