September 15, 2014 — Endo Pharmaceuticals, Inc. has been hit with a lawsuit from a man who blames his heart attack on the use of Fortesta (testosterone gel).
The lawsuit (PDF) was filed on September 10 in the U.S. District Court for the Northern District of Illinois in Chicago. It joins hundreds of similar lawsuits that were centralized in a federal Multi-District Litigation (MDL) in June.
The plaintiff in the most recently-filed case is William Lohan, a man who was 50 years old and in good health when he was prescribed Fortesta in July 2011. After taking Fortesta for about two months, he suffered a heart attack. As a result of the heart attack, he now must take medication, adhere to a strict diet, and undergo routine medical tests. He also has a higher chance of additional cardiovascular problems and death.
In recent years, a number of studies have raised concern that testosterone replacement therapy might increase the risk of heart attack, stroke, and death — especially among older men. In 2010, a clinical trial was stopped early after men on testosterone had a higher number of adverse events.
Two studies published in the last year have also found increased risks. In November 2013, JAMA published a study linking testosterone therapy with a 30% increased risk of heart attack, stroke, and death. In January, PLOS One published a study linking testosterone therapy with a doubled risk of heart attack for men over 65. Two days after that study was published, the FDA launched a safety review that is still incomplete.