New Study Verifies Need for Updated Warning Label on Low T Drugs

A recent large study backs up findings from previous smaller studies that found low T treatments increase risk of heart attack, stroke or death among men. The new study analyzed data from 55,593 men who had been prescribed low T treatments. Its results may help push the U.S. Food and Drug Administration (FDA) to update the warning labels on such drugs.

testosterone-lawsuitsPublished in PLOS One, the study found that risk of heart attack nearly tripled within the first three months of starting testosterone therapy in men under age 65 who had a history of heart disease. For men over age 65 taking the supplement, risk doubled among those with or without a history of heart disease.

While previous studies concerning testosterone treatments like AndroGel and Androderm have revealed similar results, this new study could garner more attention and demand for an updated warning label due to the large number of patient records reviewed. The FDA announced Friday it has launched an investigation to further review the risks of testosterone treatments as a result of the new research.

The results from this study alone “may not tell us very much,” said Dr. Michael Lauer, the director of cardiovascular services at the National Heart, Lung and Blood Institute, in a NY Times article. “But when you put this together with the rest of the medical literature, this tells us that we potentially have a problem.”

Currently, the labels on testosterone treatments such as AndroGel do not warn of increased cardiovascular risks.

“This study adds an enormous amount to what it known about the risks,” said Sid Wolfe of Public Citizen Health Research Group, in a Forbes article. “It’s an important breakthrough and the implications are sobering, but unfortunately, there is nothing in the current labeling or the med guides for patients.”

Millions of American men are prescribed low T treatments every year, which are often administered in the form of a gel, patch or injection. In addition, a recent report found that many patients using testosterone therapy appear to have normal testosterone levels and do not meet clinical guidelines for use of testosterone medications.

Simmons Support Team
Simmons Hanly ConroyWritten by:

Editorial Team

The Simmons Hanly Conroy Editorial Team consists of journalists, writers and editors who strive to deliver accurate and useful information to families needing legal help. Our team works alongside the firm's attorneys and partners, as well as with medical professionals and other specialists, to keep all information relevant and helpful.