FDA Requires Testosterone Drug Labeling Change to Inform of Possible Increased Risk of Cardiovascular Events

WASHINGTON, D.C. — The Food and Drug Administration is requiring the makers of approved prescription testosterone therapy products to inform of a possible increased risk of heart attack and stroke and to clarify the approved uses of the drugs.

According to a March 3 Safety Communication, the FDA has determined that there is a possible increased cardiovascular risk associated with testosterone use based on available evidence from studies and expert input from an FDA Advisory Committee Meeting.

“These studies included aging men treated with testosterone,” the communication says. “Some studies reported an increased risk of heart attack, stroke or …