After a year of reviewing the safety and side effects of prescription testosterone drugs, the U.S. Food and Drug Administration (FDA) announced on March 3, 2015 that it would require manufacturers to include heart attack and stroke risks on the warning labels for Axiron and other low T drugs.
The FDA announced in February 2014 that it would investigate potential Axiron heart attack and stroke risks after two separate studies suggested that men taking prescription testosterone drugs have an increased risk of suffering an adverse cardiovascular event.
A November 2013 study suggested that testosterone drugs increased an older man’s risk of heart attack, stroke or death by 30 percent. A later study published in PLOS ONE found that testosterone heart attack risks doubled during the first three months of use in men older than 65 and men younger than 65 with a history of heart disease.
The FDA issued a testosterone warning label update in June 2014 to include deep vein thrombosis (DVT), pulmonary embolism (PE) and other types of blood clotting events.
More than two million men have taken prescription low T drugs and may be at risk for suffering a heart attack or stroke. Several men were already injured and have filed Axiron lawsuits to seek justice for dangers they weren’t warned about.
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.