After a decade of steadily increasing insurance claims for testosterone therapy in a large US database, the number of prescriptions for testosterone plummeted in 2013. The findings were published in a research letter in the July 10 issue of JAMA.
The sharp decline coincided with the publication of two articles linking testosterone therapy with stroke and myocardial infarction (MI), which prompted the US Food and Drug Administration (FDA) to issue a safety communication and a requirement for a warning on the product label.
Jacques Baillargeon, Ph.D., from the Department of Preventive Medicine and Community Health at the University of Texas in Galveston, and colleagues traced the rise and fall of testosterone prescriptions from 2002 to 2016 among employed American men covered by a large US insurer.
Notably, "between 2013 and 2016, new testosterone use decreased by 62% and established use decreased by 48%," Baillargeon pointed out.
The "very dramatic drops" coincided with the publication of the two articles, which generated a lot of publicity and the issuance of the FDA communication. In earlier work, researchers found a quarter of the men who received a new prescription for testosterone had not had a blood test to determine serum levels.
When there was a striking increase in testosterone prescriptions in the previous decade, "we were alerted about possible overtreatment," Baillargeon said. Similarly, "I think a dramatic decline should alert us to the possibility that some men who are hypogonadal may not be receiving adequate treatment."
Men with hypogonadism who discontinue testosterone therapy, "could develop osteoporosis, a real loss of muscle mass, increase in [central] adiposity, increase in metabolic syndrome, reduced physical activity, depression, and fatigue," he warned, and some of these symptoms could put them at increased risk of cardiovascular disease.
A tripling of Testosterone Prescriptions
Testosterone use in the United States tripled from 2001 through 2011, the researchers report, and many men did not have a clear indication for the therapy, such as low serum testosterone plus symptoms such as erectile dysfunction.
Researchers identified five key times when rates of new and total testosterone prescribing changed:
1. November 6, 2013: Article by Vigen and colleagues published (JAMA.2013;310:1829-1836).
2. January 29, 2014: Article by Finkle and colleagues published (PLoS One.2014;9:e85805).
3. January 31, 2014: FDA issued a safety communication on testosterone therapy.
4. September 17, 2014: An FDA advisory committee met to discuss possible cardiovascular risks associated with testosterone therapy.
5. March 3, 2015: FDA required a testosterone label change indicating possible increased risk of MI and stroke.
There was a steep 22% drop in new testosterone users from October 2013 to December 2013 following the publication of the article by Vigen and colleagues that linked testosterone to adverse cardiovascular events.
An additional 50% decrease in new testosterone users occurred during the next 8 months subsequent to the findings by Finkle and colleagues and the FDA communication.