FDA Updates GLP-1 Label with Pulmonary Aspiration Warning

On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). 

“This was a safety-related labeling change for the glucagon-like peptide 1 receptor agonist product class,” an FDA spokesperson told Medscape Medical News.

A newly added subsection under “Warnings and Precautions” states: “There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking [these drugs], including whether modifying preoperative fasting recommendations or temporarily discontinuing [them] could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking [a GLP-1 RA].”

The warning also was added to the Adverse Reactions section of the label, and to the Postmarketing Experience section, which now includes: “Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.”

Patient Information

The Medication Guide section of the label also has new additions. Patients are counseled to tell their healthcare provider if they are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

They are alerted that the GLP-1 RAs they are taking may cause serious side effects, including food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sedation. 

Patients are advised to tell all their healthcare providers that they are taking a GLP-1 RA before they are scheduled to have surgery or other procedures.

In the Patient Counseling section of the label, physicians are advised to inform patients about the risk for pulmonary aspiration during general anesthesia or deep sedation, as follows: “Inform patients that [the drug] may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.”

Physicians are also advised to instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking [a GLP-1 RA].

Marilynn Larkin, MA, is an award-winning medical writer and editor whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.