February 5, 2015 — A lawsuit has been filed by a man who used the testosterone gel product Testim and suffered an ischemic stroke and a heart attack.
The plaintiff, Lee Cohen, is a 62 year-old resident of Maryland who started taking Testim in August 2012. After using it every day as directed, he had a stroke in April 2013 and a heart attack in July 2013. Before taking Testim, he had no history of blood clots, strokes, or serious cardiovascular problems.
The lawsuit (PDF) was filed against Auxilium Pharmaceuticals on January 19 in the U.S. District Court for the Northern District of Illinois, where at least 282 similar cases are pending against various manufacturers.
All of the lawsuits claim that the makers of testosterone replacement products failed to adequately warn about the risk of cardiovascular side effects.
Products like Testim and AndroGel are only approved for the treatment of hypogonadism, a rare hormonal disorder. However, for years, TV airwaves were inundated with ads for “Low T,” encouraging men to talk to a doctor about testosterone therapy if they had common ailments like fatigue, depressed mood, sagging muscles, and increased body fat.
The lawsuit claims that Testim caused both the heart attack and the stroke. In fact, the FDA is currently investigating several studies linking testosterone and these side effects.<?p
One study found that testosterone doubled the risk of heart attack for men over 65. Another study found that heart attack, stroke, and death were 30% more likely to occur in the first three months of starting testosterone therapy.
The FDA has already ordered manufacturers to add warnings about blood clots in the veins, also known as venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE).
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