FDA Adds New Warning to GLP-1 Drugs

— Labels now caution about pulmonary aspiration risk

MedicalToday
A close up photo of a needle of a semaglutide injection pen.

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 (, , ), tirzepatide (, ), dulaglutide (), exenatide (, ), liraglutide (, ), and lixisenatide ().

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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    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.