The U.S. Food and Drug Administration (FDA) may be one step closer to making a determination about the risks of suffering a heart attack and stroke as a result of using testosterone replacement therapy drugs.
The agency announced it would investigate testosterone heart attack and stroke risks in February 2014, after a study suggested that men age 65 years and older have a two-fold increased risk of suffering a heart attack during the first 90 days of starting testosterone replacement therapy. Men younger than 65 with a history of heart disease had have as much as a three-fold increased heart attack risk during that same time period according to the study.
The FDA announced a testosterone label change in June 2014, which would require drug manufacturers to warn of increased risks for blood clots including deep vein thrombosis (DVT) and pulmonary embolism (PE). No mention of testosterone heart attack and stroke risks were made.
Drugs used to treat low testosterone were approved to treat serious medical conditions, but have become more widely used to treat natural symptoms of aging such as low energy and low libido. More than 2.3 million American men are taking testosterone drugs, but only a small minority of these men are taking the drug to treat serious medical conditions, according to the FDA panel.
Limiting the criteria for testosterone replacement therapy use could help prevent the number of heart attacks and strokes caused by testosterone that are unnecessarily suffered by patients.
Joshua C. Cohan joined Anapol Weiss as an associate in 2013 and is a member of the firm’s Mass Tort Team. His practice focuses on pharmaceutical and medical device mass tort litigation involving complex medical, scientific, and legal issues.