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According to allegations raised in a recent testosterone drug lawsuit filed by an Ohio man and his wife, side effects of AndroGel caused several blood clots to develop and move through his heart and lungs, causing a pulmonary embolism.
The complaint (PDF) was filed by Timothy Wilkes, Sr. and his wife, Pamela, in the U.S. District Court for the Northern District of Ohio on December 14, naming the manufacturers of AndroGel, AbbVie, Inc. and Abbot Laboratories, Inc., as defendants.
According to the lawsuit, Wilkes began using Androgel in September 2011, when he was 54 years old and had no history of respiratory or cardiac events. He used the popular “low T” gel until about January 2013, indicating that he suffered multiple pulmonary emboli from Androgel, as well as severe chest pains, stomach pains, shortness of breath and other health problems which continue to this day.
The case raises allegations similar to nearly 3,500 other testosterone lawsuits pending throughout the federal court system, involving injuries allegedly caused by side effects of various different medications, including AndroGel, Testim, Axiron, Androderm and other gels, patches, pills and injections.
Plaintiffs claim that the drug makers aggressively marketed the drugs without providing adequate warnings that some men may face an increased risk of suffering a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury.
“Defendants concealed material relevant information from potential AndroGel users and minimized users and prescriber concern regarding the safety of AndroGel,” the lawsuit states. “In particular, in the warnings Defendants give in their commercials, online and print advertisements, Defendants fail to mention any potential cardiac or stroke side effects and falsely represents that AbbVie adequately tested AndroGel for all likely side effects.”
Since June 2014, complaints filed throughout the federal court system have been centralized for pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or Multi-District Litigation. The process is designed to avoid duplicative discovery into common issues, eliminate contradictory pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the Courts.
Testosterone Pulmonary Embolism and Heart Concerns
Concerns about the testosterone heart risks began to gain wide-spread attention in November 2013, when a study published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.
That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.
In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.
The FDA announced a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency indicated that use of testosterone therapy should be limited to men diagnosed with hypogonadism, which causes unnaturally low testosterone.
Doctors were encouraged not to prescribe testosterone drugs for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive experienced by most men as they get older.