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Amid a growing number of lawsuits filed nationwide over the about potential side effects of testosterone replacement therapy, new research raises questions about whether otherwise healthy men actually face an increased risk of heart attack or stroke.
In a study presented this week at the American Heart Association Scientific Session in Orlando, researchers with the Intermountain Medical Center Heart Institute in Salt Lake City say they could find no link between testosterone treatment and cardiovascular risks.
Th findings are the latest in a long series of often contradictory studies that have evaluated whether certain groups of men may be more likely to suffer a heart attack or stroke following use of popular testosterone drugs like Androgel, Axiron, Testim and others.
In March, the FDA issued a drug safety communication to announce that it is requiring new heart warnings for the drugs, which indicate there is evidence of a possible link between testosterone replacement therapy and heart problems.
The agency also urged doctors not to prescribe testosterone drugs to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests, as many experts agree that the “Low T” drugs have been widely overused in recent years by men with no real medical need for the treatment.
According to the FDA, testosterone drugs are meant to treat men suffering from hypogonadism, which causes abnormally low testosterone levels. The condition usually comes due to injuries or problems with the testicles or certain parts of the brain. The only way to confirm whether someone suffers from hypogonadism is through a serum testosterone blood test.
In this latest study, researchers looked at data on 1,472 generally healthy men between the ages of 52 and 63, who were patients at Intermountain. The study found no increased risk of heart attack or stroke, with researchers indicating that men who used testosterone supplements actually had a reduced risk of such problems.
Concerns about the testosterone drug heart risks gained widespread attention in November 2013, when a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.
This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.
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.
Since the publication of these early studies and the FDA warnings, a growing number of Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits, Depo-Testosterone lawsuits and other testoterone replacement therapy lawsuits have been filed by men throughout the United States, alleging that the drugs caused them to suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other injury.
In the federal court system, there are currently more than 2,700 cases consolidated as part of a federal multidistrict litigation (MDL), regardless of which low testosterone drug was used by the plaintiff. The lawsuits are centralized for pretrial proceedings before U.S. District Judge Matthew Kennelly in the Northern District of Illinois to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and the courts.
Each of the claims raise similar allegations that the manufacturers failed to adequately research the side effects of the medications before aggressively marketing “low T” drugs for use by men who are experiencing natural drops in testosterone as they age.
As part of the coordinated pretrial proceedings in the MDL, a samll group of Androgel cases are being prepared for early trial dates that are expected to begin
As the debate over the safety of testosterone replacement therapy continues among some in the medical community, a growing number of and other product liability cases against manufacturers of “low T” drugs continue to be filed, alleging that inadequate research was conducted before marketing the drugs and that inadequate warnings were provided for consumers and the medical community.