FDA Adds New Warning to GLP-1 Drugs

Labels of all GLP-1 receptor agonists now carry a warning about pulmonary aspiration during general anesthesia or deep sedation.

The warning affects all treatments containing GLP-1 receptor agonists, including semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), dulaglutide (Trulicity), exenatide (Byetta, Bydureon BCise), liraglutide (Victoza, Saxenda), and lixisenatide (Adlyxin).

This drug class, involving injectable and oral medications used for weight-loss and diabetes, delays gastric emptying, thus increasing risks of aspiration and regurgitation under anesthesia.

“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,” the updated labels state. As a result, patients on a GLP-1 agent should tell healthcare providers of any planned surgeries or procedures.

Despite the warning, the new labels do not offer pulmonary aspiration risk mitigation recommendations — like a temporary hold prior to surgery or modified preoperative fasting — saying available data are insufficient.

The idea of a pre-surgical GLP-1 hiatus has divided anesthesiologists as of late, with some research indicating a low aspiration risk with GLP-1 use, and other studies suggesting the opposite.

Just last week, the American Society of Anesthesiologists (ASA), along with several other medical societies, reversed its 2023 guidance which originally advised a 1-week and 1-day hold of injectable and oral GLP-1 agents, respectively, prior to elective surgery.

Instead, the new ASA guidance states that most patients can continue their medication up until the day of surgery but should follow a liquid diet for 24 hours before the procedure, depending on specific circumstances.

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