Pulmonary Aspiration Warning for GLP-1 (Glucagon-like peptide-1) Diabetes and Weight Loss Meds
GLP-1 medications help patients lose weight by delaying the movement of food from the stomach into the small intestine, suppressing appetite. However, this "delayed gastric emptying" poses a risk of pulmonary aspiration when patients are sedated for surgery or other procedures. Pulmonary aspiration happens when food or stomach contents are inhaled into the lungs.
Because of this serious risk, drug labels in the GLP-1 category now contain a warning. The following drugs received recent safety label updates with the new warning about the serious risk of pulmonary aspiration during general anesthesia or deep sedation. Patients should tell their healthcare providers about GLP-1 use prior to planning a procedure. A few other safety updates were added as noted.
GLP-1 Meds Treating Type 2 diabetes with New Pulmonary Aspiration Warnings
Adlyxin (lixisenatide) subcutaneous daily injection
FDA Approval Year: 2016
This medication has been discontinued in the U.S. but is available in the European Union, Japan, Brazil, and India and is available under the name Lyxumia in more than 60 countries.
Adylxin FDA Safety Label Change
Bydureon BCISE extended-release (exenatide synthetic) subcutaneous weekly injection
FDA Approval Year: 2017
Bydureon Extended Release Safety Label Change
Byetta (exenatide synthetic) subcutaneous twice-daily injection
FDA Approval Year: 2005
Byetta FDA Safety Label Change
Mounjaro (tirzepatide) subcutaneous weekly injection
FDA Approval Year: 2022
The Gastrointestinal Adverse Reaction section added that a small number of patients have reported the experience of dysgeusia (altered sense of taste).
Label also updated with clinical trials reports of dysesthesia (unpleasant or altered sense of touch). Based on the number of FDA Adverse Events reports received for this unusual side effect, the FDA is monitoring all the GLP-1 drugs for possible regulatory action related to the side effect.
Mounjaro FDA Safety Label Change
Ozempic (semaglutide) subcutaneous weekly injection
FDA Approval Year: 2017
Ozempic FDA Safety Label Change
Rybelsus (active ingredient: semaglutide) once-daily pills
FDA Approval Year: 2019
Rybelsus FDA Safety Label Change
Soliqua 100/33 (insulin glargine and lixisenatide) subcutaneous daily injection
FDA Approval Year: 2016
Soliqua FDA Safety Label Change
Trulicity (dulaglutide) subcutaneous weekly injection
FDA Approval Year: 2014
Clinical trials reports of stomach problems (gastrointestinal effects) added.
The postmarketing experience section now includes reports of dysgeusia (altered sense of taste).
Trulicity FDA Safety Label Change
Victoza (liraglutide) subcutaneous daily injection
FDA Approval Year: 2010
Victoza FDA Safety Label Change
Xultophy 100/3.6 (insulin degludec and liraglutide) subcutaneous daily injection
FDA Approval Year: 2016
Xultophy FDA Safety Label Change
GLP-1 Meds for Weight Loss with New Pulmonary Aspiration Warnings
Saxenda (liraglutide) subcutaneous daily injection
FDA Approval Year: 2014
Saxenda FDA Safety Label Change
Wegovy (semaglutide) subcutaneous weekly injection
FDA Approval Year: 2021
Wegovy FDA Safety Label Change
Zepbound (tirzepatide) subcutaneous weekly injection
FDA Approval Year: 2022
Zepbound FDA Safety Label Change
For more on this topic, check out: “Should You Stop Taking Ozempic Before Surgery?”
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