FDA

New FDA warning highlights rare pulmonary risk tied to popular weight loss drugs

November 13, 2024

FDA updated the labels for weight loss medications such as Ozempic and Wegovy to include a warning about the risk of pulmonary aspiration during general anesthesia.1

This warning is particularly relevant for GLP-1 medications, which slow gastric emptying and can lead to aspiration, even when patients adhere to fasting guidelines. Reports indicate that some patients inhaled stomach contents during sedation despite fasting for six to eight hours.

Affected drugs:

• Semaglutide (Ozempic, Rybelsus, Wegovy)
• Liraglutide (Saxenda, Victoza)
• Tirzepatide (Mounjaro, Zepbound)

To mitigate aspiration risks, the American Society of Anesthesiologists recommends a 24-hour liquid-only diet prior to surgery, adjusting anesthesia protocols, and using ultrasound to assess stomach contents in high-risk patients. Clinically, it's advisable to discontinue these medications at least one week before surgery, as aspiration occurs in approximately 1 in 2,000 to 3,000 sedated procedures, with nearly half resulting in lung injury.

Patients on GLP-1 medications should inform their healthcare providers about any upcoming surgeries involving anesthesia or deep sedation.

According to the new label, "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."2

Sources:

1. Nandi, P. (2024, November 7). WXYZ Detroit. FDA adds new warning to popular weight loss drugs. https://www.wxyz.com/news/health/ask-dr-nandi/fda-adds-new-warning-to-popular-weight-loss-drugs

2. FDA. (November 2024). Wegovy: Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s021lbl.pdf