Ozempic, Similar Drugs Linked to Higher Risk of GI Side Effects: Study

Mounjaro was linked to the highest risk of gastrointestinal problems like stomach paralysis and bowel obstructions, according to the findings.

New research suggests that widely used diabetes and weight-loss medications such as Ozempic, Mounjaro and Trulicity are associated with higher rates of gastrointestinal side effects when compared to older treatments like Invokana and Januvia.

In findings published earlier this month in the Annals of Internal Medicine, researchers from Brigham and Women’s Hospital and Harvard Medical School reported that all GLP-1 receptor agonists carry similar levels of gastrointestinal risk. While the drugs differ in dosing and formulation, the study concluded that their GI side effects occur more frequently than those seen with other classes of diabetes medications.

GLP-1 medications have surged in popularity in recent years after individuals have reported significant weight loss, driving widespread off-label use. Their success prompted drugmakers to release dedicated weight-loss versions of these diabetes treatments. Novo Nordisk introduced Wegovy, the weight-loss counterpart to Ozempic, while Eli Lilly launched Zepbound (tirzepatide), the weight-loss version of Mounjaro. Other drugs in the GLP-1 class include Saxenda, Byetta, Victoza, Trulicity, Rybelsus and others.

However, as sales of GLP-1 medications soared over the past few years, concerns emerged over side effects being reported among users, particularly involving gastrointestinal problems like stomach paralysis and bowel obstructions, as well as vision loss.

As a result, the manufacturers have faced a growing number of Ozempic lawsuits, Mounjaro lawsuits, Wegovy lawsuits and other GLP-1 claims, each raising similar allegations that in the drug makers’ rush to promote the benefits associated with the treatments, they failed to adequately disclose potentially serious side effects some users experience.

Led by Dr. Elizabetta Patorno, the study involved a large cohort of more than 200,000 medical records that specifically looked at the gastrointestinal side effects of semaglutide, tirzepatide and dulaglutide, the active ingredient in Trulicity, when used to treat type 2 diabetes. They then compared that data with side effects reported by users of sodium-glucose cotransporter 2 (SGLT-2) inhibitors like Januvia and Farxiga.

According to the findings, the three GLP-1 drugs had very similar risks of gastroparesis, pancreatitis and bowel obstruction that required emergency department visits or hospitalizations. However, users of those drugs faced higher risks of gastrointestinal problems when compared to SGLT-2 medications.

The data indicates Ozempic users faced a 22% higher risk of GI problems, and Trulicity users faced a 36% increased risk. The researchers found that the highest risk of GI side effects was linked to Mounjaro, with users facing a more than 50% higher risk of stomach paralysis and similar problems when compared to SGLT-2 competitors.

“These findings suggest that dulaglutide, semaglutide, and tirzepatide have similar gastrointestinal safety profiles in adults with T2D. This study provides clinicians with evidence to weigh the benefits and risks of these medications.”

– Dr. Elizabetta Patorno, Comparative Gastrointestinal Safety of Dulaglutide, Semaglutide, and Tirzepatide in Adults With Type 2 Diabetes

GLP-1 Gastrointestinal Injury Lawsuits

The findings come as Novo Nordisk and Eli Lilly face more than 2,900 GLP-1 gastrointestinal injury lawsuits brought in the federal court system, which have been centralized in a multidistrict litigation (MDL) in the Eastern District of Pennsylvania under U.S. District Judge Karen Marston, who is overseeing coordinated discovery and pretrial proceedings. Each complaint alleges GLP-1 manufacturers failed to provide adequate warning that the diabetes and weight loss drugs could cause severe gastrointestinal problems.

Judge Marston has indicated she intends to select a small group of representative cases to serve as early “bellwether” trials, providing insight into how juries may respond to recurring evidence and testimony.

Before such trials can begin, Judge Marston has ordered both sides to resolve several issues that could have broad implications for the litigation, including preemption and general causation. Once those matters are addressed, the MDL is expected to proceed with preparing the first set of cases for jury consideration. While the verdicts will not directly determine the outcome of other GLP-1 claims, they are likely to shape settlement negotiations.

If the parties do not reach a GLP-1 settlement agreement after the bellwether trials, Judge Marston is likely to begin remanding the cases back to their original courts for individual trial dates.

Sign up for more health and legal news that could affect you or your family.