Both tirzepatide labels updated on the basis of SURPASS-CVOT

The FDA has approved updates to both US tirzepatide labels. Mounjaro now carries a new indication to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for them, and the diabetic retinopathy warning was revised on both Mounjaro and Zepbound ^[2][1].

Both changes trace back to the same study: trial I8F-MC-GPGN, titled "The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes" (SURPASS-CVOT), conducted in adults with type 2 diabetes and established cardiovascular disease ^[1][2].

What changed on each label

For Mounjaro, the FDA approved supplement S-044, which adds the new indication "to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events" ^[2][5]. The agency also approved changes to the Warnings and Precautions section on Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy, "based on the SURPASS-CVOT" ^[2]. A second supplement, S-045, states that the 2.5 mg dose of tirzepatide can be used for ongoing glycemic control in patients with type 2 diabetes ^[2]. The Mounjaro label's Recent Major Changes table now lists both the new cardiovascular indication and the retinopathy warning as dated 08/2026 ^[3][5].

For Zepbound, the supplement (S-041) did not add a new indication. Lilly submitted it on October 24, 2025, and the FDA received it October 27, 2025 ^[1]. The approval letter says the application adds information from the completed cardiovascular outcomes trial and "includes changes to the WARNINGS AND PRECAUTIONS, Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy based on the SURPASS-CVOT," plus revisions to Patient Counseling Information to align with the Dosage and Administration section ^[1].

There is a wording difference worth flagging. The Zepbound approval letter refers to the warning by the same title used in the Mounjaro label ^[1], but the posted Zepbound prescribing information lists section 5.8 as "Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus," dated 08/2026 ^[4]. In both labels, the Highlights summary of that warning reads the same way: monitor patients with a history of diabetic retinopathy for progression ^[3][4].

Zepbound's approved uses were not changed. It remains indicated, with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight plus at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity ^[4].

The letters were signed by Mahtab Niyyati, MD, Associate Director of Therapeutic Review (Acting) in the FDA's Division of Diabetes, Lipid Disorders, and Obesity — the Zepbound letter on August 26, 2026, and the Mounjaro letter on August 27, 2026 ^[1][2]. DailyMed shows the Mounjaro label updated August 27, 2026, and the Zepbound label updated August 28, 2026 ^[3][4].

The FDA waived the pediatric study requirement for the Mounjaro cardiovascular supplement because "the necessary studies are impossible or highly impracticable, as the condition rarely or never occurs in pediatric populations" ^[2].

Why it matters for patients

A cardiovascular indication on a label is a formal FDA finding, not a marketing claim, and it can affect how prescribers and insurers treat the drug for people with type 2 diabetes and high cardiovascular risk. Mounjaro (tirzepatide) now has that indication; Zepbound (tirzepatide), the same molecule marketed for weight and sleep apnea, does not ^[5][4].

The retinopathy update is the safety half of the story. Both labels still direct clinicians to monitor people with a history of diabetic retinopathy for progression ^[3][4]. The specific numbers behind the change — how many retinopathy events occurred in each trial arm, and the size of the cardiovascular benefit — are not stated in the approval letters or the Highlights sections available here, so they are not yet known from these sources.

Also relevant: the FDA told Lilly that all promotional materials must be "promptly revised" to match the new labeling, including "prominent disclosure of the important new safety-related information," with a statement of intent due within 7 days of the letters ^[1][2].

What happens next

Lilly had 14 days from each letter to submit the final content of labeling in electronic format, which then becomes publicly viewable in labeling repositories ^[1][2]. Patent information tied to the supplements is due to the FDA within 30 days of approval ^[1][2]. Both labels are marked "Revised: 8/2026" ^[5][3][4].