What did @harleymeds.com actually say?
The claim is bold: the FDA "just removed all warnings" from testosterone injection labels related to cardiovascular risk, following a "massive study" involving thousands of men that supposedly proved long-term testosterone cypionate "does not cause cardiovascular issues like heart attack strokes and high blood pressure." The creator then uses this as a direct sales pitch for their clinic. That framing matters, because this isn't just a science communication video. It's a recruitment tool built on a regulatory claim that isn't fully accurate.
The actual FDA action in 2024 was more limited than this video suggests. The agency updated its labeling guidance based on results from the TRAVERSE trial, but "removing all warnings" is not what happened. The update was a modification, not a wholesale removal of cardiovascular cautions.
Does the science back this up?
Partly. The TRAVERSE trial (Lincoff et al., 2023, New England Journal of Medicine) is the real study behind this claim, and it was genuinely significant. But it did not show testosterone has zero cardiovascular risk. It showed non-inferiority, meaning testosterone didn't meaningfully increase major adverse cardiac events compared to placebo in men with hypogonadism and elevated cardiovascular risk at baseline.
That is a meaningful finding. The trial enrolled over 5,200 men and ran for a median follow-up of roughly 33 months. Rates of heart attack, stroke, and cardiovascular death were similar between the testosterone and placebo groups. The FDA used this data to revise a 2015 warning that had specifically cautioned about possible increased cardiovascular risk, and that revision is legitimate science.
But TRAVERSE also found increased rates of atrial fibrillation, pulmonary embolism, and acute kidney injury in the testosterone group. Those aren't nothing. Saying testosterone injections "do not cause cardiovascular issues" flattens a more complex set of findings into a clean sales line.
What did they get wrong (or right)?
Let's give credit where it's due: the underlying study is real, the FDA did make a label update in 2024, and the general message that the old cardiovascular black-box-style concern has been walked back is accurate enough for a layperson's summary.
Where this falls apart is in the absolutism. Saying the FDA "removed all warnings" is not accurate. The agency updated specific language about major adverse cardiovascular events, but testosterone labeling still carries warnings. It still notes risks including polycythemia, sleep apnea, and, based on TRAVERSE findings, atrial fibrillation and thromboembolic events.
Claiming testosterone "does not cause" high blood pressure is also a stretch. Blood pressure effects from TRT vary by individual, dose, and hematocrit changes. The TRAVERSE trial was not designed to exonerate testosterone from all hemodynamic effects, and it didn't.
- The FDA label update is real, but not a total warning removal
- TRAVERSE showed non-inferiority on major cardiac events, not zero risk
- Atrial fibrillation and clotting risks were actually elevated in the trial
- High blood pressure was not definitively cleared by this data
What should you actually know?
If you've been avoiding TRT specifically because of the 2015 era cardiovascular warnings, the science has genuinely shifted. TRAVERSE is a well-designed, adequately powered RCT, and the FDA's label revision reflects that. For men with diagnosed hypogonadism who don't have severe untreated cardiac disease, the major-event risk profile looks more reassuring than it did a decade ago.
That said, TRT is not risk-free. Polycythemia, which is an increase in red blood cell mass, is a real and monitored concern on injectable testosterone. Atrial fibrillation risk was statistically elevated in TRAVERSE. Men with existing clotting disorders need individualized assessment. Blood pressure should still be monitored.
The decision to start TRT belongs between you and a licensed clinician who has reviewed your labs, your history, and your risk factors. A TikTok comment section is not a clinical intake form, regardless of how convenient that might seem.
The bottom line
The TRAVERSE trial is legitimate science and the FDA label revision is real. But "removed all warnings" and "does not cause cardiovascular issues" are overstatements that strip nuance from a study that still found elevated risks for specific cardiac events. This video uses a real regulatory update to make an absolute claim the evidence doesn't support, and pairs it with a direct solicitation for a commercial clinic. Be skeptical of any health claim that conveniently ends with "comment below."