Ozempic Users Face Increased Risk of Lung Complications After Digestive Tract Exams: Study

Side effects of Ozempic and similar GLP-1 drugs approved for treatment of diabetes and weight loss can delay gastric emptying and increase the risk of aspiration during upper GI endoscopic procedures.

Individuals using the blockbuster weight loss and diabetes drugs Ozempic, Wegovy, Mounjaro or Zepbound before undergoing digestive tract exams may face an increased risk of aspiration during the procedure, according to the findings of a new study.

The drugs are all part of a popular class of medications, known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which work by delaying gastric emptying and promoting weight loss. However, when users are sedated with a full stomach, they could vomit and suffocate during surgery.

The American Society of Anesthesiologists (ASA) first sounded the alarm about the Ozempic aspiration risks during sedation last year, warning healthcare provides to make sure patients stop taking the medications before elective surgery. However, there is now increasing evidence that problems may occur during other procedures, including digestive tract exams.

GLP-1 Health Concerns

Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been increasingly prescribed as a diet drug in recent years, making it a blockbuster treatment that is now used by millions of Americans.

As a result of the popularity of Ozempic for weight loss, Novo Nordisk has introduced a higher dose version under the brand name Wegovy, which is specifically approved as a diet drug. However, it contains the same active ingredient.

Eli Lilly has introduced two competing drugs from the same class of medications, starting with Mounjaro (tirzepatide) for diabetes treatment in 2022, and a weight loss version of the drug approved by the FDA last year, marketed under the brand name Zepbound.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits, each raising similar allegations that the drug makers placed a desire for profits before consumer safety by failing to disclose all of the risks associated with use of the medications.

In a study published this month in the journal Cureus, researchers from the U.S. and Middle East sought to determine the real-world effects and risks raised by the ASA aspiration warnings issued last year.

The team, led by Ruaa Al Sakka Amini, of the nephrology department at Abdali Hospital in Jordan, performed a retrospective cohort study of a global research network of electronic health records known as TriNetX., looking for evidence of aspiration in patients on Ozempic or another GLP-1 RA after esophagogastroduodenoscopy (EGD) procedures, which involve an endoscopic exam of the upper gastrointestinal tract under sedation.

The team looked at data on nearly 60,000 patients who used a GLP-1 drug before undergoing the procedure, and nearly 6 million patients who did not.

The researchers indicate they found a “significant risk” of aspiration pneumonitis among patients taking drugs like Ozempic and Mounjaro. However, they noted these did not appear to result in an increase of respiratory failures or intensive care unit admission.

“Our analysis showed a small risk of aspiration pneumonitis in patients on GLP-1RA undergoing elective EGD; however, it was significantly increased compared to the control group,” the researchers determined. “Our findings highlight the importance of following an individualized approach to preoperative management that takes into consideration GLP-1RA indications and other aspiration risk factors, including advanced age, impaired gag reflex, and GI symptoms such as nausea and abdominal distention. Future prospective studies with detailed pharmacokinetic and pharmacodynamic data are necessary to fully understand the nuances of each GLP-1RA and their impact on gastric emptying and aspiration risk.”

August 2024 GLP-1 Stomach Paralysis Lawsuit Update

While a number of Ozempic aspiration lawsuits have been filed by former users, alleging that the manufacturers should have provided better warnings to users and the medical community about the importance of stopping the medication before sedating procedures, most of the U.S. litigation has focused on the drug makers’ failure to disclose the risk of gastroparesis from GLP-1 drugs, which involves paralysis of the stomach that can result in obstructions, blockages or other severe gastrointestinal problems.

Given common questions of fact and law raised in hundreds of these gastroparesis complaints brought in the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established coordinated pretrial proceedings for all Ozempic and other GLP-1 lawsuits earlier this year, transferring complaints filed throughout the federal court system to U.S. District Judge Gene E. K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania. However, Judge Pratter passed away of May 17, and the litigation was just recently reassigned to District Judge Karen S. Marston.

As the litigation continues to grow, it is expected that the Court will establish a bellwether program, by working with plaintiffs and defendants to determine what Ozempic lawsuits are representative of the greater litigation, and then sending them through case-specific fact discovery before scheduling a series of early test trials, which will help the parties gauge how juries may respond to certain evidence and testimony that would be repeated in potentially hundreds of trials.

Following coordinated discovery and any early bellwether cases, if the parties are unable to negotiate Ozempic gastroparesis settlements or another resolution for the litigation, Judge Marston may later remand each claim back to the U.S. District Court where it was originally filed for trial.