The plaintiffs, Demetric Taylor and his wife, allege that Fortesta is responsible for his heart attack. According to the complaint:
“Defendants’ advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the ‘symptoms’ of low testosterone.”
Taylor alleges that he and his doctor relied on the drug-makers’ claims that low testosterone was a widespread disease that needed treatment with testosterone replacement therapy.
In fact, the website advertising Fortesta suggests that symptoms of “low testosterone” may include reduced sexual libido, erectile dysfunction, fatigue, depressed mood, decreased strength or muscle mass, and osteoporosis. The problem is that these symptoms are very common and often caused by conditions other than low testosterone.
Recent studies have found that only about half of men on testosterone therapy actually have hypogonadism — the only medical condition Fortesta is FDA-approved to treat — in which the testicle produce little or no hormones.
Another problem is that Fortesta can have severe side effects. The Prescribing Information includes warnings about the risk of blood clots in the legs. The FDA is currently investigating studies that have linked testosterone therapy with higher rates of heart attack and stroke, especially in older men with heart disease. The FDA is currently investigating these studies.
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