The U.S. Food and Drug Administration (FDA) began investigating testosterone heart attack and stroke risks in February 2014 after two separate studies suggested that men had an increased risk of suffering an adverse cardiovascular event while taking prescription testosterone drugs.
More than 1,300 men have filed testosterone lawsuits to seek justice and compensation for heart attack, stroke and other cardiovascular injuries experienced while taking prescription testosterone drugs, Forbes reported.
Testosterone drugs, including Androgel, Axiron and Fortesta, are prescribed to men with low testosterone (Low T) caused by a serious medical condition. More than 2.3 million prescriptions were written in 2013, according to the FDA. But an overwhelming amount of prescriptions are written to treat Low T caused by aging—although the drugs were not approved for this purpose.
A 2014 PLOS One study found that the heart attack risk doubled during the first three months of testosterone use in men older than 65 and younger men with a history of heart disease. A previous study suggested that men had a 30 percent increased risk of suffering a testosterone heart attack or stroke.
The FDA issued a safety communication in March 2015 requiring Low T manufacturers to update the warning labels to include heart attack and stroke risks. Manufacturers must also clearly state the intended use.
The March 2015 warning came too late for the thousands of men who suffered serious testosterone side effects. Men who suffered a testosterone heart attack or stroke should contact a lawyer to find out if they are eligible to file a testosterone lawsuit. According to Forbes, the first Low T lawsuit is scheduled to go to trial in the fall of 2016.
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.