Mounjaro and Zepbound labels updated after cardiovascular trial

The FDA approved updated prescribing information for the two tirzepatide products, Mounjaro and Zepbound, based on a cardiovascular outcomes trial called SURPASS-CVOT, according to approval letters signed Aug. 26 and Aug. 27, 2026 ^[1][2]. Mounjaro gained a new heart-related indication, and both labels had their diabetic retinopathy warning revised ^[1][2].

Mounjaro's new indication covers reducing the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with type 2 diabetes who are at high risk for those events ^[2][3][5]. It sits alongside the drug's existing use for blood sugar control in adults and in children 10 years and older with type 2 diabetes ^[3][5]. A separate Mounjaro supplement approved at the same time states that the 2.5 mg dose can be used for ongoing blood sugar control in adults with type 2 diabetes ^[2].

The trial behind the changes is identified in the letters as I8F-MC-GPGN, titled "The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)," and was conducted in adults with type 2 diabetes and established cardiovascular disease ^[1][2]. The FDA approval letter for Zepbound supplement 041 states plainly that the retinopathy change was based on that trial ^[1].

Neither letter nor the current label summaries include the trial's results. Hazard ratios, event rates and participant counts for SURPASS-CVOT have not been disclosed in these documents.

On retinopathy, Mounjaro's label carries a section titled "Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy," dated 08/2026 ^[3][5]. Zepbound's is titled "Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus," also dated 08/2026 ^[4]. Both tell prescribers to monitor patients with a history of diabetic retinopathy for progression ^[3][4]. The letters say the sections were updated based on SURPASS-CVOT but do not describe the changes line by line ^[1][2].

FDA waived the pediatric study requirement for the Mounjaro cardiovascular application, saying the condition rarely or never occurs in pediatric populations, and said the other Mounjaro supplement was exempt ^[2]. The Zepbound supplement was exempt as well ^[1].

Why it matters for patients

The new Mounjaro indication applies to a specific group: adults with type 2 diabetes who are at high risk of cardiovascular death, heart attack or stroke. It does not change what Zepbound, the same molecule sold for weight reduction and obstructive sleep apnea, is approved to treat ^[4].

People with type 2 diabetes who have diabetic retinopathy of the eye appear in both labels' warnings, and the label language directs monitoring for progression ^[3][4]. The approval documents do not say how often that monitoring should happen, what the trial found about eye outcomes, or how the revised wording differs from the previous version. Those details have not been reported in these documents.

Both letters also require Eli Lilly to revise promotional materials so they match the new labeling, including prominent disclosure of new safety information ^[1][2]. That covers advertising and other materials that make claims about the products.

What happens next

Within seven days of each letter, the company must submit a statement of intent to comply with federal promotional labeling rules ^[1][2]. Within 14 days, it must submit the updated label content in structured product labeling format so it can be posted in public labeling repositories ^[1][2]. Within 30 days, it must file patent information on Form FDA 3542 for listing in the Orange Book ^[1][2].

DailyMed entries for Mounjaro and Zepbound were updated Aug. 27 and Aug. 28, 2026 ^[3][4].