Study Suggests There May Not Be a Link Between Ozempic, Mounjaro and Post-Surgery Aspiration Pneumonia

Findings come shortly after the FDA ordered drug makers to include new label warnings about GLP-1 surgical aspiration side effects.

A new study raises questions about recent warnings required by federal regulators, which indicate that taking Ozempic and similar drugs before surgery could lead to respiratory surgical complications.

In findings published in JAMA Network Open on March 4, researchers from Harvard Medical School say they were unable to find any link between preoperative use of glucagon-like peptide-1 (GLP-1) receptor agonists, like Ozempic, Wegovy and Mounjaro, and postoperative aspiration pneumonia. The findings challenge new label warnings placed on the drugs last year.

GLP-1 Surgical Concerns

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.

In November of last year, the U.S. Food and Drug Administration (FDA) agreed, adding new drug safety label warnings for the entire class of medications, urging patients to inform their healthcare providers that they are taking a GLP-1 drug before going into surgery or undergoing other medical procedures.

The warnings came amid growing concerns about a number of potential side effects of Ozempic, Wegovy and other GLP-1 drugs, which have skyrocketed in popularity in recent years. However, questions have emerged about whether the drug makers aggressively pushed wider use of the medications for weight loss, without adequately researching and disclosing a number of serious health risks users may find.

In addition to reports of surgical aspiration, users have also reported experiencing severe and long-term intestinal problems, including gastroparesis or stomach paralysis risks, which a growing number of Ozempic lawsuits indicate were intentionally withheld from users and the medical community.

In this new study, a research team led by Dr Yuan-Hsin Chen attempted to investigate the risk of post-operative aspiration pneumonia among users of GLP-1 medications. The cohort study included 366,476 individuals who underwent common surgical procedures from April 1, 2020 to September 30, 2022, looking at the outcomes of those who took GLP-1 medications before the procedures and those who did not.

According to their findings, there was no significant difference in the rate of postoperative aspiration pneumonia among patients who took GLP-1 medications and those who did not.

“This cohort study found no significant association between the preoperative use of GLP-1 RAs and short-term postoperative aspiration pneumonia despite growing concerns about the adverse effects of these medications after surgery,” the researchers concluded. “This finding suggests that it may be beneficial to reassess the preoperative withholding guidelines for GLP-1 RAs.”

However, due to a lack of information on the long-term side effects of Ozempic and similar drugs, the researchers advised clinicians to approach treatment of patients taking the medications with caution and called for further research on long-term postoperative outcomes.

GLP-1 Lawsuits

Despite the new findings, previous warnings and studies have led to more than 1,300 GLP-1 lawsuits being filed in federal courts nationwide. Those claims have been centralized in the Eastern District of Pennsylvania for coordinated pretrial proceedings under U.S. District Judge Karen Marston.

Judge Marston has put the litigation on track for bellwether test cases but has tasked the parties with first resolving a number of “cross cutting” issues, such as general causation and other issues, like whether plaintiffs will need to provide specific gastroparesis diagnostic testing, and whether the complaints are preempted by federal law.

Following the resolution of those issues, Judge Marston is expected to direct the parties to select a series of representative GLP-1 lawsuits for early bellwether test trials, to help gauge how juries will respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the outcomes of such early test trials are not binding on other claims, they could help potentially facilitate an Ozempic settlement agreement that would avoid the need for each individual case to be set for trial in the future.