Pulmonary Aspiration Warning Added to Ozempic, Wegovy, Mounjaro and Other GLP-1s Regarding Use Before Anesthesia or Deep Sedation

Federal regulators have added new warnings to Ozempic, Wegovy, Mounjaro and similar drugs that are part of a class of medications known as glucagon-like peptide-1 receptor agonists (GLP-1s), indicating that the popular diabetes and weight loss treatments have been linked to incidents of pulmonary aspiration among patients undergoing elective surgeries.

The American Society of Anesthesiologists (ASA) first warned about the surgical risk of pulmonary aspiration from Ozempic in July 2023, when it issued guidance for the medical community about the importance of patients stopping use of GLP-1 medications before elective surgery.

Since the medications work by delaying gastric emptying, the group warned that users may be prone to vomit and aspirate while under anesthesia, which could lead to life-threatening surgical complications. However, information about the GLP-1 pulmonary aspiration risk was not included on the warning labels for Ozempic, Wegovy and other widely used drugs in this class, until now.

On November 1, the U.S. Food and Drug Administration (FDA) issued a drug safety label update for the entire class of medications, adding new information to the “Warnings and Precautions” section of Ozempic, Mounjaro, Zepbound, Wegovy, Rybelsus, Saxenda, Trulicity, Byetta and Victoza.

“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,” the new labels will indicate. “Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking Ozempic, including whether modifying preoperative fasting recommendations or temporarily discontinuing Ozempic could reduce incidents of retained gastric contents.”

Under the “Medication Guide” section of the drug labels, the FDA urges patients to inform their healthcare providers that they are taking a GLP-1 drug before going in for surgery or other medical procedures. However, doctors are also being urged to tell patients about the risks of pulmonary aspiration during surgery when the medications are prescribed, and instruct them to inform healthcare providers before any planned procedures.

GLP-1 Stomach Paralysis Lawsuits

The new GLP-1 pulmonary aspiration warnings come as the manufacturers already face hundreds of Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits, each raising similar allegations that users and the medical community were not adequately warned about serious risks that may result from delayed gastric emptying caused by the medications.

Most of the lawsuits involve claims that former users were left with gastroparesis from Ozempic or other GLP-1 medications, which involves complete stomach paralysis that impedes the movement of stomach muscles, resulting in persistent vomiting, hospitalization and other long-term health outcomes.

Given common questions of fact and law raised in the claims, all federal GLP-1 lawsuits have been centralized as part of an MDL, or multidistrict litigation, where U.S. District Judge Karen S. Marston is overseeing coordinated discovery and pretrial proceedings.

The court is currently focusing early discovery and motions practice on a series of “cross cutting” issues that impact all claims, including an evaluation of general causation, pre-emption and whether specific gastroparesis testing is needed in the lawsuits.

Following rulings on early motions that may limit the size and scope of the litigation, it is expected that Judge Marston will schedule a series of early bellwether test trials, to help the parties gauge how juries may respond to expert testimony and evidence that will likely be repeated throughout hundreds of pending lawsuits.

While the outcomes of such early test trials are not binding on other claims, they are often critical to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation, potentially facilitating Ozempic settlement negotiations that would avoid the need for each individual case to be set for trial in the future.