Concerns About Ozempic Suicidal Thoughts Resurface in New Study

Over the last year, U.S. and European Union regulators have largely dismissed concerns that side effects of Ozempic and Wegovy may cause suicidal ideation. However, a new study may provide important scientific evidence about the problems reported by some users of the popular weight loss and diabetes drugs.

In findings published this week in the medical journal JAMA Network Open, an international group of researchers from the Zucker School of Medicine and the University of Zurich indicate that patients disproportionately report having suicidal thoughts on Ozempic, according to data contained in a global database maintained by the World Health Organization (WHO), leading to calls for further studies to be conducted.

Ozempic (semaglutide) is a new generation treatment that was just introduced in late 2017, for the treatment of people with Type 2 diabetes. However, amid aggressive advertisements that promoted the weight loss benefits, Ozempic has been widely 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, both drugs contain the same active ingredient.

Although advertisements promote the drugs as safe and effective, with few long-term side effects, former users are now pursuing Ozempic lawsuits and Wegovy lawsuits against Novo Nordisk, each raising similar allegations that the widespread use of the drugs has made it clear that the drug label fails to adequately warn about the risk of severe and long-lasting gastroparesis, or stomach paralysis, as well as intestinal obstructions.

FDA, E.U. Ozempic Suicidal Thoughts Investigations

Earlier this year, an FDA quarterly report on adverse psychiatric drug events revealed the agency had received 201 reports of suicide or suicidal ideations linked to Ozempic, Wegovy and other GLP-1 RAs through the end of September 2023.

At the time those findings were released, the FDA indicated it was evaluating the drugs to determine “the need for regulatory action.” However, days later the agency announced it had found no evidence linking Ozempic and suicidal thoughts, raising questions among many consumer advocates about the reason for ongoing reports of problems.

An investigation is also underway by the European Union’s European Medicines Agency (EMA), which began investigating Ozempic suicide risks in July 2023, following similar reports from Iceland of patients having suicidal thoughts. The reports involved both Ozempic and Saxenda (liraglutide). However, the EMA has not issued any recommended changes to the drugs’ labels.

World Health Organization Data Points to Ozempic Suicide Risks

In this latest study, led by Dr. Georgios Schoretsanitis, researchers examined the same two drugs, conducting a disproportionality analysis of a global database of drug adverse event reactions collected by the World Health Organization (WHO). The researchers looked for incidents of suicidal and self-injurious behavior between November 2000 and August 2023.

According to the analysis, researchers only found increased rates of suicidal ideation among Ozempic and Wegovy users, who faced a 45% higher risk of considering suicide than their peers. The researchers noted that the number of suicide reports linked to Ozempic are increasing through the years, as the drug has increased in popularity.

The researchers report they also found that the risk of Ozempic suicidal thoughts more than quadrupled if the patients were taking antidepressants and benzodiazepines at the same time.

“When repeating the analysis after excluding cases in which antidepressants were coreported, we did not detect a disproportionality signal. In contrast, when repeating the analysis after excluding cases in which benzodiazepines were coreported, the disproportionality remained significant,” the team wrote. “This is consistent with an interaction between baseline psychopathology and semaglutide effects and warrants further investigation. Although EMA stated that no update to the product information is warranted, based on these findings, we believe that a precaution of use in patients with psychiatric disorders or psychological lability could be added in the semaglutide package insert.”

The researchers noted that the FDA already requires Wegovy to carry a suicide and depression warning, but not Ozempic.

Novo Nordisk claims there are no known causal connections between Ozempic and suicide, and the drug does not carry label warnings in the United States or EU alerting patients to potential suicidal thoughts risks. However, a warning for patients to be monitored for suicidal thoughts and behaviors does appear on the drug Wegovy, which also contains semaglutide.

Suicide risks and ideations have long been linked to weight loss drugs, such as Contrave and Qsymia, making it difficult for them to gain wider approval in the U.S. However, Wegovy and similar drugs are being introduced at a rapid rate, since they are much more effective than earlier obesity treatments. As the drugs continue to be touted for weight loss, diabetes control, lowering the risk of heart disease and other cardiovascular benefits, the use of the medications is likely to continue to spread.

August 2024 Ozempic, Mounjaro, GLP-1 Lawsuit Update

While this latest study and other regulatory investigations have focused on the risk of Ozempic suicidal thoughts, most of the U.S. litigation has been filed over the drug makers’ failure to disclose the risk of gastroparesis from Ozempic and other 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 stomach paralysis 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 on May 17, and the litigation has been 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.