Testosterone Treatment Prescribing Guidelines Often Ignored, Analysis Finds
A new analysis has found that many doctors are ignoring current treatment guidelines when they prescribe testosterone treatments like AndroGel to their male patients. The study, which appeared this month in Public Health Reports, echoes concerns recently raised by U.S. health regulators, as well as plaintiffs in hundreds of testosterone lawsuits currently moving forward in U.S. courts.
The analysis drew data from insurance records on more than 60,000 men over the age of 40 who had been prescribed low T therapy from 2001 to 2010. Of those, 20% received a new testosterone prescription even though they exhibited hormone levels considered normal under current treatment guidelines. Nearly 25 percent of men included in the study did not have their testosterone levels checked before receiving a prescription, and nearly half did not undergo testing during their first year of treatment.
“It’s possible that in some cases physicians judge that a patient’s symptoms, such as fatigue and loss of muscle mass, merit testosterone therapy without clinically defined low testosterone levels,” the study’s lead author said in a news release announcing its publication.
It should be noted that AndroGel and other testosterone treatments are only approved for men who suffer from hypgonadism (low testosterone) due to an underlying medical condition. They have not been proven safe and effective for men whose low hormone levels are merely the result of the normal aging process.
Testosterone Heart Concerns
The new analysis was published just as the U.S. Food & Drug Administration (FDA) issued its second safety alert for low T therapy in a little more than a year. The agency has been reviewing the cardiovascular risks associated with the medications since January 2014, and on March 3rd announced that their labels would be updated to warn that prescription testosterone treatments might be associated with an increased risk of heart attack or stroke. The agency also said that the new labeling would clarify that the drugs aren’t approved to treat age-related testosterone drops, and that testosterone replacement therapy has not been proven safe and effective for this purpose.
Since the FDA began its investigation in 2014, hundreds of men have filed testosterone lawsuits that seek compensation for heart attacks, strokes, blood clots and other cardiovascular problems allegedly related to their use. Among other things, the complaints claim that sales of the medications were driven by marketing tactics that wrongly positioned low T therapy as an appropriate treatment for low libido, fatigue and other problems associated with male aging.
Men who allegedly experienced serious heart events due to their use of AndroGel and other prescription testosterone treatments may be entitled to compensation for medical bills, lost wages and other damages. To learn more about filing your own testosterone lawsuit, please contact Bernstein Liebhard LLP today by calling (877) 779-1414.