February 5, 2015 — A man who had a heart attack and stroke after taking Testim for less than one year has filed a lawsuit against the manufacturer, Auxilium Pharmaceuticals for failing to warn about the risk.
The lawsuit (PDF) was filed on January 19. The plaintiffs are Lee Cohen and his wife, Kyoko, both from Maryland. Mr. Cohen, age 62, started taking Testim in August 2012. Eight months later, he had an ischemic stroke (blood clot in the brain). In July 2013, he had a heart attack.
The manufacturer of Testim, Auxilum Pharmaceuticals, is accused of failing to adequately warn about the risk of heart problems. In the last year, nearly 300 similar lawsuits have been filed against several manufacturers in a federal Multi-District Litigation (MDL) in Illinois.
Auxilium is accused of aggressively marketing Testim for the treatment of “Low T,” encouraging men to self-diagnose themselves with hypogonadism if they had symptoms like fatigue, depressed mood, decreased muscle mass, or other common ailments.
The U.S. Food and Drug Administration (FDA) is investigating several studies linking testosterone and heart attacks, including one that found a doubled increased risk for men over 65 years old. Another study found a 30% risk of heart attack, stroke, and death among older men in poor health who started testosterone.
The FDA has also recently ordered updates to the label on Testim to warn about venous blood clots, including venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE).
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