Ozempic, Mounjaro Side Effects May Increase Risk of Cough: Study

Findings come as drug makers face nearly 3,000 lawsuits over failure to warn about stomach paralysis and other gastrointestinal side effects linked to Ozempic, Mounjaro and other GLP-1 medications.

Compared to some of the most frequently used diabetes drugs on the market, new research has found that drugs like Ozempic and Mounjaro are 30% more likely to leave users with a chronic cough.

According to a study published in JAMA Otolaryngology – Head & Neck Surgery on November 26, glucagon-like peptide-1 (GLP-1) receptor agonists used to treat diabetes and obesity are also linked to an increased risk of developing a chronic cough when compared to other well-known second-line diabetes drugs, like Byetta, Januvia and sulfonylureas.

GLP-1 medications include the blockbuster treatments Ozempic and Mounjaro, which have seen a sharp rise in popularity in recent years after being linked to significant weight loss side effects. This has prompted drug makers to release dedicated weight-loss versions of these diabetes drugs as well. Novo Nordisk introduced Wegovy (semaglutide), 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, along with surging sales have come concerns over certain side effects being reported by users, particularly involving gastrointestinal problems like stomach paralysis and non-arteritic anterior ischemic optic neuropathy (NAION), a rare but serious form of optic-nerve damage that can cause permanent blindness.

As a result, Novo Nordisk and Eli Lilly face a growing number of Ozempic lawsuits, Mounjaro lawsuits and Wegovy lawsuits, each raising similar allegations that the rush to cash in on the benefits associated with the treatments prevented them from adequately testing and disclosing potentially serious side effects.

This new study included researchers from the Mayo Clinic, the University of Southern California’s Keck School of Medicine, Stanford University, and Cedars Sinai Medical Center, who were led by Dr. Tyler J. Gallagher. 

The team looked at data on more than 427,000 individuals using medical records from 70 health organizations. This data compared the effects of GLP-1 medications to other second-line diabetes treatments including dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and sulfonylureas.

According to the findings, the rate of chronic coughs linked to GLP-1 use was virtually identical to that of SGLT-2 inhibitors like Januvia, and slightly higher than other diabetes treatments overall by about 29%.

“This cohort study suggests an association between GLP-1RA use and chronic cough. Further research is needed to confirm the existence, strength, and mechanisms of this association.”

– Dr. Tyler J. Gallagher, Glucagon-Like Peptide-1 Receptor Agonists and Chronic Cough

The researchers noted that previous studies had linked GLP-1 medications to increased coughing in patients with gastroesophageal reflux disease (GERD), yet until now had not looked at the risk of chronic coughing specifically in patients without GERD.

GLP-1 Stomach Paralysis Lawsuits

The data was released as GLP-1 manufacturers face more than 2,900 GLP-1 stomach paralysis lawsuits brought throughout the federal court system, which have been centralized into a multidistrict litigation (MDL) under U.S. District Judge Karen Marston in the Eastern District of Pennsylvania.

Judge Marston is overseeing coordinated discovery and pretrial proceedings in the litigation and has indicated she plans to select a small group of representative “bellwether” trials to serve as early test cases, which will allow the parties to see how an actual jury may respond to evidence and testimony that would be repeated throughout thousands of similar claims.

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.

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