The FDA has determined that new safety information regarding  “the risk of pulmonary aspiration during elective surgeries or procedures required general anesthesia and sedation” should be included in labeling for glucagon-like peptide 1 receptor agonist (GLP-1RA) products,including tripzepatide , a GIP/GLP RA.Type 2 diabetes and obesity are treated with GLP-1 RAs. By increasing insulin and reducing glucagon secretion, they replicate the effects of the natural GLP-1 hormone that is secreted by endocrine cells in the stomach to regulate glycemia brought on by meal consumption. GLP-1 RAs maximize nutrient absorption while lowering food intake and preventing weight gain by inhibiting stomach emptying and promoting satiety. New guidelines have been released by the European Medicines Agency (EMA) for patients who require profound sedation or general anesthesia while taking glucagon-like peptide 1 receptor agonists (GLP-1 RAs). Before administering anesthetic or sedative agents, health professionals should take into account the known risk of delayed gastric emptying with GLP-1 RAs in order to reduce the risk of aspiration and aspiration pneumonia during surgery, according to the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

In spite of reported adherence to preoperative fasting guidelines, this update is based on infrequent post-marketing reports of pulmonary aspiration in patients receiving GLP-1 receptor antagonists undergoing elective surgeries or procedures requiring deep sedation or general anesthesia and having residual stomach contents.

The GLP-1 RA product information will be updated appropriately informing patients that if they are planned for surgery under heavy sedation or anesthesia and take these medications they should notify the attending physician. As of November 1, 2024, this additional safety information has been added to the prescribing instructions for all GLP-1 RA medications that are currently on the US market.