FDA adds aspiration warning to GLP-1 labels for semaglutide, tirzepatide and liraglutide
A class-wide label change tells people on GLP-1 drugs to raise planned surgery or sedation with their providers, while the FDA says it lacks data on lowering the risk.
People who take a GLP-1 receptor agonist now find a new warning on the label: food or liquid can enter the lungs during surgery or other procedures that use general anesthesia or deep sedation [1]. The FDA applied that change across the drug class on November 5 [1].
The products affected are semaglutide (Ozempic, Rybelsus, Wegovy), liraglutide (Saxenda, Victoza) and tirzepatide (Mounjaro, Zepbound) [1]. The medical term for the risk is pulmonary aspiration.
Filed under Warnings and Precautions, the new text points to "rare postmarketing reports" of aspiration in patients who still had stomach contents before their procedure even though they had reported following fasting instructions [1]. The same language was added to the Adverse Reactions and Postmarketing Experience sections, and the risk also appears in the Medication Guide and in the counseling information written for prescribers [1].
An FDA spokesperson described the action as "a safety-related labeling change for the glucagon-like peptide 1 receptor agonist product class" [1].
What the agency did not provide is a way to prevent the problem. The label states that available data are insufficient to guide steps for lowering aspiration risk under anesthesia or deep sedation, leaving open whether different fasting instructions or a temporary pause in the medication would cut the number of cases in which food stays in the stomach [1]. No holding period before a procedure appears in the labeling, because the agency said the data do not support one [1].
An FDA approval letter for the Ozempic revision is dated November 1, 2024, and was signed by Monika Houstoun, Pharm.D., M.P.H., deputy director for safety in the agency's Division of Diabetes, Lipid Disorders, and Obesity [2]. The letter grants a supplement Novo Nordisk filed on October 4, 2024, and notes that the FDA had notified the company on September 6, 2024, that new safety information about aspiration belonged in labeling for GLP-1 receptor agonist products generally [2]. Email correspondence on October 11 and October 16, 2024, came before approval [2]. That letter covers Ozempic only; approval dates for the matching changes to the other companies' labels have not been disclosed.
The material written for patients asks them to speak up before a procedure is on the calendar rather than on the day of it, telling providers about their GLP-1 use ahead of any planned surgery or procedure [1]. Prescribers are directed to explain that the drug may slow stomach emptying, which is what can create complications with anesthesia or deep sedation [1].
Why it matters for patients
These medicines are prescribed for type 2 diabetes and for weight loss, and are taken as weekly or daily injections and as a daily pill, so the warning reaches a broad group of users [1]. The change is written at the class level, which means it is not tied to a single manufacturer's product.
Slow stomach emptying is the reason the label ties the concern to sedation level instead of to a specific type of operation [1]. Aspiration in this setting is described in the labeling as rare [1].
The step the labeling actually asks of patients is disclosure before scheduling, not after [1]. It does not tell anyone to skip or stop doses, and the FDA said the evidence does not answer whether doing so would help [1]. The label also does not address what a patient should do about an individual scheduled dose [1].
What happens next
Novo Nordisk has 14 days from the November 1 letter to file its updated label content in structured product labeling format, and 7 days to submit a statement that it will bring promotional materials into line with the new safety information [2].
The FDA's safety notification of September 6, 2024, covered the class, and the Ozempic revision was approved first [2]. It has not been reported when the revised labels for the other products were approved or posted publicly.
It also has not been reported whether the FDA will ask for studies on fasting windows, drug-holding periods or other approaches meant to reduce how much food remains in the stomach before sedation [1].
Sources
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