If you have ever looked at a testosterone product label, you may remember a prominent, boxed warning about cardiovascular risk. That warning, in place since 2015, was removed in February 2025 in one of the most significant regulatory shifts in the history of testosterone therapy (Healthline, 2025).
What Is a Black Box Warning?
A black box warning, formally called a boxed warning, is the FDA's strongest safety label. It signals that a drug carries a serious or life threatening risk and is meant to make prescribers think twice before writing a prescription. Many drugs with boxed warnings see prescribing rates drop sharply after the label change is announced.
For testosterone products, the warning specifically called out a possible increased risk of heart attack and stroke. It was added during a period of intense scrutiny following a small number of observational studies suggesting cardiovascular harm.
Why the FDA Changed Course
The 2025 update was driven primarily by the results of the TRAVERSE trial, a large randomized controlled study that followed thousands of men on testosterone gel or placebo for nearly three years. The trial found that major cardiovascular events occurred at similar rates in both groups: 7.0 percent on testosterone versus 7.3 percent on placebo (HealthSpectra TRAVERSE summary).
TRAVERSE was specifically designed to settle the cardiovascular question that earlier observational studies had raised. Because randomized trials are the gold standard for determining cause and effect, the results gave the FDA confidence that the boxed warning was no longer justified by the science.
What the Label Says Now
The updated label still mentions cardiovascular considerations, but no longer in boxed form. Patients with a recent heart attack, stroke, or unstable cardiovascular disease are still advised to discuss the risks with their physician. The change is essentially a downgrade: from a strong, prominent warning to a more standard precaution.
