The updated warning, issued Nov. 5, stems from rare postmarketing reports of patients who experienced pulmonary aspiration, when food or liquid enters the lungs, while undergoing elective surgeries or procedures requiring anesthesia despite following fasting guidelines prior to surgery.
The FDA’s new safety information, which appears under the “Warnings and Precautions” section, notes that the data currently available is insufficient to provide specific recommendations for mitigating the risk, such as modifying preoperative fasting guidelines or temporarily discontinuing GLP-1 therapy before surgery.
In addition, the “Adverse Reactions” and “Postmarketing Experience” sections have been revised to include references to pulmonary aspiration. The Medication Guide Section has also been updated to remind patients about the potential risks of delayed stomach emptying associated with GLP-1 RAs, which may complicate the administration of anesthesia, the report said.
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