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Amid continuing concerns about the potential side effects of low testosterone treatments and the widespread overuse of the drugs without a true medical need, a new study suggests that hospitalized older men who receive the hormone replacement therapy may actually have a reduced chance of readmission.
In a study published in the medical journal Mayo Clinic Proceedings earlier this month, researchers with the University of Texas Medical Branch found that certain men given testosterone drugs were less likely to need to be readmitted within a month of being discharged from the hospital. The research suggests that the increased strength and health may play a factor.
The findings following recent attempts by the FDA to limit use of the drugs to men with confirmed drops in testosterone levels caused by a medical condition, due to a potential risk of heart attacks, strokes, deep vein thrombosis, pulmonary embolism and death that have been linked to treatments for low testosterone in recent years.
In the retrospective cohort study, researchers reviewed data on 6,372 nonsurgical hospitalizations between January 1, 2007, and December 31, 2012, involving men age 66 and older who had been previously diagnosed with a testosterone deficiency.
The findings suggest that just under 10% of men given testosterone were readmitted after 30 days, compared to 13% of the men who were not on testosterone therapy.
“It is possible that our findings of decreased hospitalization among male Medicare beneficiaries who received testosterone therapy reflect the improved health, strength and exercise capacity seen in previous studies,” lead author Jacques Baillargeon, UTMB professor of epidemiology in the department of preventative medicine and community health, said in a press release. “Our findings suggest that one of the benefits of androgen therapy may be quicker recovery from a hospital stay and lower readmission rates.”
Testosterone Treatment Heart Risks
While testosterone replacement therapy was originally expected to be a niche treatment, amid aggressive marketing of “low T” gels, creams and patches, the industry grew to generate more than $2 billion in annual sales in recent years.
Drugs like Androgel, Axiron, Testim, Androderm and others were originally intended only for men with confirmed testosterone deficiencies caused by a medical condition, but they have increasingly been prescribed for “lifestyle reasons”, to increase strength, stamina and reverse the natural drops in testosterone levels all men experience as they age.
Over the past two years, concerns about testosterone treatment heart risks have emerged, following publication of several studies that suggest the medications may cause certain users to face an increased risk of heart attacks, strokes, deep vein thrombosis, pulmonary embolism and other injuries. This led the FDA to require new warnings last year, urging doctors to only prescribe the drugs for men with a true medical need.
There are currently more than 5,000 product liability Androgel lawsuits, Axiron lawsuits, Testim lawsuits and other testosterone treatment lawsuits pending throughout the federal court system involving men who allege the drug manufacturers recklessly promoted the drugs and withheld information about the potential heart risks.
Given the similar allegations raised in the lawsuits, cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
As part of the coordinated proceedings, a series of Androgel trials are expected to begin between April and November 2017, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
If testosterone injury settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.