by Matt Weik, BS, CSCS, CPT, CSN
Testosterone injections, pills, and creams typically used for TRT and HRT purposes come with some warnings on the label. You’ve probably noticed them if it’s something you use regularly. But recently, testosterone labels got an update.
Being that I don’t use TRT, this news came somewhat as a shock to me, but the FDA just removed the long-standing warning about heart attacks and strokes. Yup. The warning label is totally gone. Instead, a new warning about increased blood pressure is now required.
In this article, we’re going to dive deeper into this change, why it happened, the new blood pressure warning that no one saw coming, and what all of this means for you (if you’re a testosterone user).
Disclaimer: This article is for informational purposes only and is not meant to treat or diagnose any condition. It is recommended that you speak with your doctor before starting any exercise program, making changes to your nutrition plan, or adding any new supplements into your current regimen.
Why the Change to Testosterone Labels?
This update from the FDA comes after the TRAVERSE clinical trial, which looked at the cardiovascular risks of testosterone therapy.
The study found that testosterone replacement therapy (TRT) didn’t increase the risk of major heart-related events compared to a placebo. That was enough for the FDA to remove the boxed warning about heart attacks, strokes, and cardiovascular death from testosterone labels.
But there’s a catch. The FDA still wants age-related hypogonadism (low testosterone due to aging) to remain listed as a “limitation of use.”
So, while the heart risk warning is gone, restrictions on who should be using TRT are still in place.
What the TRAVERSE Trial Found
The TRAVERSE trial was designed to settle the debate on testosterone’s heart risks.
The study focused on men with low testosterone and either existing heart disease or a high risk for it. The results? Testosterone therapy was non-inferior to a placebo when it came to major cardiac events.
In plain English, that means TRT didn’t increase heart attack or stroke risks compared to men not using it.
Over a 33-month period, 7% of men on TRT experienced a major cardiovascular event, compared to 7.3% of those taking a placebo. The numbers were so close that the FDA felt confident removing the boxed warning.
The New Blood Pressure Warning on Testosterone Labels
The FDA didn’t just remove a warning — they added a new one. Studies show that testosterone therapy can lead to increased blood pressure. Because of this, the FDA now requires product-specific details about blood pressure changes on testosterone labels. If a product hasn’t yet completed blood pressure testing, a general warning must still be added.
This move follows previous FDA actions dating back to 2014 and 2015 when they initially warned about heart attack, stroke, and death risks tied to testosterone therapy. Those warnings led to stricter guidelines and a requirement for drug companies to conduct safety trials.
The Blood Pressure Concerns Aren’t New
The FDA has been monitoring blood pressure concerns with testosterone for years.
Between 2016 and 2017, they reviewed premarket studies on new testosterone products, including injections and oral formulations. These studies flagged potential blood pressure increases, prompting the FDA to require postmarket testing by 2018.
Now, the agency is making it official. Every testosterone product must include updated blood pressure warnings on its label.
This change affects all forms of testosterone therapy, including oral pills, topical gels, transdermal patches, buccal systems, and injections.
What the Change to Testosterone Labels Means for Test Users
If you’re on TRT, this change removes a major red flag from the label but adds a new concern that you need to be made aware of.
While the risk of heart attacks and strokes isn’t as alarming as once thought, users still need to monitor their blood pressure. High blood pressure is a serious issue (they don’t call it the “silent killer” for nothing), especially for those already at risk of cardiovascular disease.
The bottom line? TRT is still only approved for men with medically diagnosed low testosterone, not just for those looking to boost energy or muscle mass.
While you don’t need to be as concerned about your cardiovascular health being chipped away with testosterone use, you should now be extra careful and pay close attention to your blood pressure.