FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments.

In a report published last week in the journal Cureus, researchers with Miller Scientific, led by Dr. Larry E. Miller, reviewed incidents submitted to the U.S. Food and Drug Administration (FDA)’s adverse event reporting system involving glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which have become some of the most widely used prescription medications on the market in the U.S.

Researchers identified hundreds of thousands of adverse events submitted to the agency over the last 19 years, indicating that newer drugs like Ozempic and Mounjaro are linked to higher rates of serious side effects among younger patients and women, while older drugs, like Victoza and Byetta, were linked to higher rates of mortality.

GLP-1 Side Effects Concerns

Ozempic (semaglutide) was initially introduced for the treatment of people with Type 2 diabetes in late 2017. 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.

Due to the initial success of Ozempic in the weight loss market, Novo Nordisk subsequently launched Wegovy, a higher dose version of semaglutide that was specifically approved as a diet medication. Similarly, Eli Lilly received FDA approval for its Type II diabetes drug Mounjaro (tirzepatide) in 2022, and its weight loss counterpart, Zepbound was approved by the FDA last year.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, GLP1 RAs have been linked to a rapidly growing number of potentially serious health problems, including gastroparesis side effects, and non-arteritic anterior ischemic optic neuropathy (NAION) vision problems, which can cause sudden vision loss due to a lack of blood flow to the optic nerve.

As a result of the drug makers’ failure to adequately warn about these risks, thousands of former users are now pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits, each raising similar allegations that the manufacturers placed a desire for increased profits above consumer safety by failing to research and adequately disclose side effects users may experience.

For this latest study, Dr. Miller’s team looked at reports submitted to the FDA’s Adverse Event Reporting System (FAERS) from the second quarter of 2005 until the first quarter of 2024. They found 287,201 adverse events linked to the class of medications.

According to the findings, older GLP-1s, like Byetta and Victoza carried twice the risk of death than others of the class. However, the study also found nearly three times the risk of serious adverse events linked to Ozempic, a 30% increased risk for users of Wegovy, and more than two and half times the risk for users of Rybelus, all of which use semaglutide as the active ingredient.

The adverse events caused by Ozempic and similar new GLP-1s were more likely to affect younger patients and women, the researchers determined. However, some of the medications, like Trulicity, Bydureon, Mounjaro and Zepbound, were linked to lower adverse event reporting rates than their competitors.

“This pharmacovigilance study utilizing the FAERS database identified potential safety signals of increased mortality and serious AE reporting associated with certain GLP-1RAs, particularly the earlier approved liraglutide agents Byetta and Victoza,” the researchers concluded. “These findings highlight the importance of proactive postmarket surveillance to characterize the real-world safety profiles of individual GLP-1RA drugs.”

While the study did not calculate the types of adverse events reported, researchers postulated that elevated awareness about the risk of gastrointestinal problems with Ozempic and Mounjaro have led to more reporting among younger patients in recent years.

The findings came just days after a report in the Annals of Emergency Medicine, which warned emergency rooms to be better prepared to address Ozempic problems among patients, particularly when emergency sedation is needed, which may increase the risk of vomiting or aspiration due the delayed gastric emptying caused by these drugs.

In June 2023, the American Society of Anesthesiologists (ASA) issued a warning about the Ozempic aspiration risks, encouraging doctors to have patients stop taking the drugs before any elective procedure. However, this is not possible for emergency procedures, and many emergency rooms are not gathering information about patients that may be on the medication.

August 2024 Ozempic, Mounjaro Lawsuits Update

Given the widespread use of Ozempic, Mounjaro and other GLP1-RA medications, thousands of individuals are now pursuing failure to warn lawsuits against the manufacturers, each raising similar allegations and questions of law.

To help manage and coordinate pretrial proceedings, the U.S. Judicial Panel on Multidistrict Litigation established a GLP-1 RA drug lawsuits earlier this year, centralizing claims brought throughout the federal court system in the Eastern District of Pennsylvania, for coordinated discovery and pretrial proceedings.

Last month, the judge now presiding over the litigation issued a pretrial order authorizing the direct filing of new Ozempic lawsuits in the federal MDL, which will avoid delays associated with transferring claims from various different federal district courts nationwide.

As part of the coordinated management of the growing litigation, it is expected that the parties will identify a small group of “bellwether” cases to prepare for early trial dates, which will help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

However, if the parties are unable to negotiate GLP1 settlements or another resolution for the litigation following any early test trials, each individual lawsuit may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.