FDA Adds Delayed Gastric Emptying as Adverse Event on Semaglutide Label

The FDA has added a new label change for semaglutide (Ozempic; Novo Nordisk) that includes a new section referring to delayed gastric emptying. The label includes postmarking reports showing rare instances of pulmonary aspiration for patients receiving glucagon-like peptide-1 (GLP-1) receptor agonists and undergoing elective surgeries or procedures that require general anesthesia or deep sedation and had “residual gastric contents despite reported adherence to preoperative fasting recommendations.”¹

Anesthesia, Semaglutide, Delayed Gastric Emptying, FDA | Image Credit: LIGHTFIELD STUDIOS | stock.adobe.com

According to the label, there are insufficient data to inform the recommendations to mitigate the risk of pulmonary aspiration during anesthesia. This includes recommendations for preoperative fasting and temporarily discontinuing the drug.¹

At the American Diabetes Association 84th Scientific Sessions, presenters discussed potential concerns surrounding GLP-1 medications, which included aspiration during anesthesia. In June 2024, the American Society of Anesthesiologists recommended stopping GLP-1 medications for patients who are planning surgery, but there was no data linking the medication to an increased risk of aspiration for upper endoscopy. The presenters added that patients should be educated on the information regarding this medication so that they are prepared for any potential concerns.²

At the end of October 2024, the American Society for Metabolic and Bariatric Surgery released new recommendations on the usage of GLP-1 receptor agonists in the perioperative period. The recommendation includes shared decision-making between the care team and the patient, including an assessment of risk factors, and preoperative diet modifications and/or modifications to the anesthesia plan.³

The organization cites concerns about delayed gastric emptying, causing residual gastric content on the day of the procedure as well as gastrointestinal-related adverse events, like nausea, vomiting, abdominal pain, and constipation. The new recommendations hope to offer guidance for the safe management of GLP-1 therapy regardless of indication, which now includes type 2 diabetes, overweight and obesity, and heart failure.³

The first recommendation includes shared decision-making between the procedural, anesthesia, and prescribing care teams to better balance the metabolic need to decrease GLP-1-related risk. In this part of the recommendation, the organization suggests that care teams consider the escalation phase, which has been associated with higher risk of delayed gastric emptying with GLP-1s; higher doses and weekly dosing, which increase the likelihood of gastrointestinal adverse events; presence of gastrointestinal symptoms, which can signal delayed gastric emptying and intestinal transit times; and medical conditions beyond GLP-1 usage that could affect delayed gastric emptying.³

As per the recommendations, the assessment of the various risk factors should be considered in advanced time to allow for adjustments in care, which could include diet modification and evaluation of GLP-1 discontinuation. For the second recommendation, the organization highlights ways to minimize the risk of aspiration, which can include diet modifications and altering the anesthesia plan. The recommendation suggests that a liquid diet for at least 24 hours can be used when there is concern for delayed gastric emptying. Additionally, a gastric ultrasound can be used to assess the risk of aspiration. Shared decision-making should also be used on the day of the procedure when there is a concern for retained gastric contents, according to the recommendation.³

REFERENCES

1. Ozempic [package insert] Bagsvaerd, Denmark: Novo Nordisk; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf

2. Gallagher A. Experts Discuss Serious Adverse Events for GLP-1 Medications. Pharmacy Times. June 23, 2024. Accessed November 14, 2024. https://www.pharmacytimes.com/view/experts-discuss-serious-adverse-events-for-glp-1-medications

3. Kindel TL, Wang AY, Wadhwa A, et al. Multisociety clinical practice guidance for the safe use of glucagon-like peptide-1 receptor agonists in the perioperative period. Surg Obes Relat Dis. Published online October 29, 2024. doi:10.1016/j.soard.2024.08.033