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Prescriptions for testosterone replacement therapy have declined in recent years, following publication of studies and warnings about the link between side effects of testosterone drugs and a potential increased risk of heart attacks, strokes and sudden death.
University of Texas researchers published a research letter last week in the Journal of the American Medical Association (JAMA), which highlights the steadily decreasing number of testosterone drug prescriptions in recent years, following a steady increase in the number of men prescribed the treatments over the prior decade.
Researchers used data from a large commercial health insurance database, examining information on nearly 10 million men ages 30 and older from 2002 through 2016. They looked for the percentage of men prescribed testosterone therapy and the number of new users each year.
According to the findings, testosterone drug prescriptions increased from 2002 to 2013, by which time the percentage of men using testosterone drugs like AndroGel and Testim reached 3.2 percent. However, a number of studies published in recent years have suggested that the drugs may be exposing the men to serious heart risks, raising questions about the widespread use of the drugs among men without any real medical need for the treatment.
The number of men taking testosterone treatments began to decline in 2013, decreasing to 1.67% by 2016.
Concerns about the testosterone drug heart risks began to emerge in 2013, leading the FDA to issue a safety warning in January 2014. Following a safety review, the agency decided to require new warnings about the potential risk of heart attacks and strokes from testosterone replacement therapy in 2015, urging doctors to only prescribe the drugs to men diagnosed with hypogonadism backed up by laboratory testing.
Researchers note that the decline came across all age groups, and researchers tracked dips in prescriptions occurring directly after the publication of major studies raising testosterone side effect concerns.
“After a decade of growth, the percentage of US men receiving testosterone prescriptions decreased from 2013 through 2016,” the researchers concluded. “The steepest decrease coincided with 2 published reports of testosterone-associated averse cardiovascular events and an FDA communication.”
There are currently more than 6,000 Androgel lawsuits and other claims pending against makers of testosterone replacement therapy, alleging that users and the medical community were not adequately warned about the potential health risks, including an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, blood clots and other life-threatening health problems.
Given similar questions of fact and law presented in lawsuits filed throughout the federal court system, the testosterone lawsuits are currently centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, as part of an MDL, or multidistrict litigation.
A series of 19 Androgel bellwether trials are expected to begin between October 2018 and March 2019, unless the drug maker negotiates settlements with plaintiffs in the coming months.
Late last month, Actavis announced that it has reached a tentative settlement to resolve all Androderm lawsuits involving their competing testosterone patch. In addition, Auxilium Pharmaceuticals has agreed to settle hundreds of Testim lawsuits and Eli Lilly has agreed to settle all Axiron lawsuits, involving those other testosterone gel products.