After a year of investigating testosterone heart attack risks, the U.S. Food and Drug Administration (FDA) is now requiring prescription testosterone drug manufacturers to update the warning labels.
The FDA Announced on March 3, 2015 that it would require the makers of prescription testosterone drugs to include heart attack and stroke as potential testosterone side effects on the warning labels.
The agency launched an investigation into AndroGel heart attack and stroke risks in February 2014 after a medical study suggested that men who took testosterone drugs had an increased risk of suffering an adverse cardiac event.
In June 2014, the FDA announced manufacturers would be required to add blood clots – including deep vein thrombosis (DVT) and pulmonary embolism (PE) – to Low T drug warning labels.
Manufacturers must also specify that prescription testosterone drugs are not approved to treat low T as a symptom of aging, and that the drugs are only approved to treat serious medical conditions that result in lower testosterone levels. However, the majority of the two million men taking testosterone are treating Low T symptoms caused by aging, according to The New York Times. These men have unknowingly subjected themselves to potentially dangerous cardiac risks. For many, the warnings came too late.
Numerous men have already suffered a heart attack or stroke while taking testosterone and have filed AndroGel lawsuits to seek justice and compensation for medical expenses.
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.