Testosterone Therapy Linked to Obstructive Sleep Apnea Risk: Study

The side effects of testosterone replacement therapy may increase the risk of obstructive sleep apnea among men, according to the findings of a new study. 

Researchers with Harvard Medical School published a study late last month in the urology medical journal BJU International, which downplayed concerns over testosterone heart risks, but also discovered an association between the use of the medications and an increased risk of obstructive sleep apnea (OSA).

The study sought to look at the association between testosterone treatments and previously detected risks of thromboembolism, cardiovascular disease, stroke, coronary artery disease, heart failure and sleep apnea.

Television advertisements and other drug marketing in recent years have encouraged men to speak with their doctor about the use of low testosterone treatments if they experience decreases in energy, strength, sex drive or other symptoms that are linked to natural drops in testosterone levels as all men age. However, as a number of studies have highlighted the risk of heart attacks, strokes, blood clots and death that maybe caused by side effects of testosterone therapy, health experts have suggested that the medications have been widely overused in recent years by men with no real medical need.

Testosterone replacement therapy, which includes blockbuster drugs like Androgel, Testim, Axiron and others, were initially expected to be a niche treatment for men suffering from testosterone deficiency caused by a medical condition, known as hypogonadism. However, as men receive prescription of the drugs for life-style reasons, the industry grew to generate more than $2 billion in sales annually in recent years.

In the latest study, researchers looked at data on 3,422 men in the U.S. military, as well as retirees and dependants who were between the ages of 40 and 64. The researchers identified those who were prescribed a testosterone drug between 2006 and 2010 for low testosterone and matched them with men of the same age and with the same comorbidities who did not use testosterone.6

According to the findings, 16.5% of men who used testosterone developed obstructive sleep apnea, compared to only 12.7% in the control group. However, the findings did not indicate a link between heart disease and thromboembolism risks.

“This study adds to growing evidence that the cardiovascular risk with TRT may be lower than once feared,” the researchers concluded. “The elevated risk of OSA in men using TRT is noteworthy.”

A number of previous studies differed on the findings regarding heart risks and blood clots. In fact, in 2016 there was enough evidence for the FDA to require new warnings about the potential risk of heart attacks and strokes from testosterone replacement therapy, urging doctors to only prescribe the drugs to men diagnosed with hypogonadism backed up by laboratory testing.

Testosterone Litigation

The study comes as thousands of men are now pursuing Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone prescription lawsuits, indicating that the drug makers failed to adequately warn that they may face an increased risk of suffering a heart attack, stroke, blood clot or death while using the medications.

According to allegations raised in the testosterone prescription litigation, pharmaceutical companies marketing the drugs withheld important safety warnings from consumers and the medical community, while promoting the widespread use of the medications among men without a true need for testosterone treatments.

Given the similar allegations raised in the lawsuits, more than 6,500 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.

While two global testosterone settlements involving Axiron and Testim claims are expected to resolve about one-third of the pending litigation, no agreements have been reported involving Androgel lawsuits, which involve claims against AbbVie for injuries associated with their market-leading testosterone gel product.

AbbVie has already been hit with several massive jury awards in early bellwether trials, including $150 million in punitive damages in July 2017 and a verdict of $140 million in a second case in October 2017. However, the award in the first case was overturned during post-trial motions, and retrial is set for this month.