FDA adds SURMOUNT-3 and SURMOUNT-4 data to the Zepbound label

The FDA approved five supplemental applications for Zepbound (tirzepatide) on October 18, 2024, adding new trial data and safety language to the drug's official label ^[1]. The changes came in five separate supplements, filed as S-005, S-006, S-011, S-015, and S-019, all approved together in a single letter to Eli Lilly ^[1].

One of the biggest changes adds results from two Phase 3 trials to the label. SURMOUNT-3 tested tirzepatide against placebo in adults without type 2 diabetes who have obesity or are overweight with weight-related health problems, after they first completed an intensive lifestyle program ^[1]. SURMOUNT-4 looked at whether tirzepatide helped people keep weight off over time, also compared to placebo, in a similar group of adults ^[1]. Both studies are now cited in the label's clinical trials section ^[1].

The approval also renamed a key warning. Section 5.2 of the Warnings and Precautions section, which used to carry a different title, is now called "Severe Gastrointestinal Adverse Reactions" ^[1]. The label also now lists dysgeusia, a taste disturbance, and separately dysesthesia, an abnormal sensation on the skin, among reported side effects in the clinical trials section ^[1].

Another supplement removed an entire subsection from the label. Section 2.1, titled "Patient Selection," was deleted, and the FDA also approved editorial changes to the indication statement and matching updates to the Medication Guide that patients receive with their prescription ^[1].

Separately, the FDA required a new warning about pulmonary aspiration, a condition where stomach contents are inhaled into the lungs, during surgeries or procedures that use general anesthesia or deep sedation ^[1]. This warning was not specific to Zepbound. The agency had already notified drugmakers on September 6, 2024, that this safety information needed to be added across GLP-1 receptor agonist products as a class ^[1]. The Zepbound label update, filed as S-019, put that notice into effect for tirzepatide specifically ^[1].

Why it matters for patients

People who take Zepbound, or are considering it, now have access to more clinical trial evidence in the official label, including data on how the drug performed after a structured weight-loss program and how well people maintained weight loss over time ^[1]. The added side effect listings, dysgeusia and dysesthesia, mean patients and doctors have a fuller picture of reactions reported during testing, even though the label does not say how common these reactions were ^[1].

The pulmonary aspiration warning is notable because it was not created just for Zepbound. It reflects a decision the FDA made for the whole class of GLP-1 drugs, meaning patients on other medications in this category may see similar warnings appear on their labels around the same time ^[1]. Anyone with an upcoming surgery or procedure requiring anesthesia may want to be aware this warning exists, since it speaks directly to that situation ^[1].

The removal of the "Patient Selection" section and changes to the indication statement are described in the approval letter as largely editorial ^[1]. The letter does not specify what information was in that section before it was deleted, so it is not yet known from this source exactly what patients lose or gain from that specific change.

What happens next

Under the terms of the approval, Lilly had until November 1, 2024, 14 days after the October 18 letter, to submit the finalized label text in a standard electronic format and to update related paperwork with the FDA ^[1]. The company was also required to submit a statement of intent within 7 days, by October 25, 2024, confirming it would update promotional materials to match the new label ^[1]. The source does not indicate when the updated label became visible on public FDA repositories or pharmacy inserts.