Big Drop in Testosterone Therapy May Be Linked to Research, Bulletins on Health Risks

By Josh Garcia
Friday, January 18, 2019

Testosterone use decreased dramatically from 2013 to 2016, amid an outpouring of study results and FDA alerts regarding associations between testosterone products and risk of stroke, heart attack and/or death.

Jacques Baillargeon, PhD, Professor of Epidemiology at University of Texas Medical Branch, has co-authored multiple research letters published in JAMA concerning testosterone usage trends in the United States. The first, published in 2013, was based on commercial health insurance data and examined testosterone prescriptions from 2001 to 2011. The data showed androgen use increased more than threefold during the study period.

Baillargeon and other scientists completed a follow-up study examining testosterone prescriptions from 2002 to 2016, again using commercial health insurance data. They found that although testosterone use increased from 2002 to 2013, utilization during the subsequent three years fell 48 percent among established users and 62 percent among new users.

“We were very interested in whether reports and FDA communications that came out in late 2013 and early 2014 and their subsequent publicity influenced testosterone use and prescribing patterns in the U.S.,” Baillargeon says.

The reports to which he refers include investigations published in JAMA and PLOS ONE in 2013 and 2014, respectively. The FDA cited these investigations in its Drug Safety Communications regarding testosterone products. Those alerts were issued in January 2014 and March 2015. The second communication required changes in labeling to inform consumers of increased cardiovascular risk associated with testosterone products.

“Those articles were covered on the nightly news and well-publicized across the country,” says Randall Urban, MD, Vice President and Chief Research Officer at the University of Texas Medical Branch and co-author of the JAMA research letters with Baillargeon. “As a clinician, I know these reports spurred questions in my patients. I think they’re exactly what drove the decline [in testosterone prescriptions].”

“It’s important to continue to track testosterone use over time. When you see dramatic shifts, you have to ask yourself, Who is getting treatment that shouldn’t, and who’s not getting treatment that should?”
— Jacques Baillargeon, Phd, Professor of Epidemiology at University of Texas Medical Branch

Changes in Care

Despite the medical risks testosterone therapy may pose for some men, it can be vital for those diagnosed with hypogonadism.

An Endocrine Society-appointed task force recently created new testosterone therapy guidelines to help ensure men receive proper care. The guidelines, published in The Journal of Clinical Endocrinology & Metabolism in 2018, marked the first updates to testosterone therapy guidelines since 2010.

“We hope these recommendations will help clarify and dispel much of the misinformation about testosterone therapy,” Shalender Bhasin, MD, endocrinologist at Brigham and Women’s Hospital in Boston and co-author of the new guidelines, stated in a news release upon publication of the guidelines. “Relying on the latest and highest-quality scientific evidence will help men and their healthcare providers determine when testosterone treatment is appropriate and when it is unlikely to benefit an individual’s health.”