Psychiatric Side Effects Linked to Ozempic, Wegovy and Other Popular GLP-1 Drugs in New Study

The findings of a new study found a “significant association” between the use of new-generation weight loss and diabetes drugs known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as Ozempic, Mounjaro and Wegovy, and psychiatric side effects.

Chinese researchers indicate that the use of GLP-1 RAs increased the risk of nervousness, stress, eating disorders and insomnia, according to findings published earlier this month in the medical journal Frontiers in Endocrinology.

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 also released competing GLP-1 drugs in the form of Mounjaro (tirzepatide), approved for diabetes treatment in 2022, and a weight loss version of the drug was approved by the FDA last year, which is 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 against the manufacturers, each raising similar allegations that the drug labels fail to adequately warn about the risk of severe and long-lasting side effects, including a form of severe stomach paralysis, known as gastroparesis.

In this new study, researchers used data on adverse events (AEs) reported to the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the first quarter of 2023, involving the use of GLP-1 RAs. They analyzed a total of 8,240 reports of psychiatric adverse events, out of a total of 181,238 adverse event reports during that time period.

According to the findings, those taking Ozempic, Wegovy and similar drugs faced an increased risk of nervousness, stress, fear of injection and sleep disorders. In addition, they found that the drugs were associated with a host of eating disorders, including binge eating, fear of eating and self-induced vomiting, the latter of which was reported nearly four times as often for those who took a GLP-1 drug when compared to those who did not.

While they found different drugs within the class had different onset times, the median time from taking the drugs to the development of psychiatric adverse events was about 31 days.

“Our findings demonstrate a significant association between GLP-1 RAs and the development of specific psychiatric AEs,” the researchers concluded. “Despite the observational nature of this pharmacovigilance study and the inherent limitations of the FAERS database, our preliminary findings in this work could provide a better basis for understanding the potential psychiatric AEs that may occur with GLP-1 RA treatment, assisting clinicians to focus on these AEs and provide early intervention for optimal risk management.”

Ozempic Psychiatric Risk Concerns

The study’s findings came about a month after an FDA quarterly report on adverse psychiatric drug events linked to Ozempic, Wegovy and other GLP-1 RAs, which was released on January 2 and revealed the agency had received 201 reports of suicide or suicidal ideations through the end of September 2023.

At the time those findings were released, the FDA indicated it was evaluating the drugs for “the need for regulatory action.” However, days later the agency announced that no evidence that using them leads to suicidal thoughts or actions.

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).

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, the drug Wegovy, which is also a weight loss medication sold in the U.S. using semaglutide, does carry such a warning, calling for patients taking the drug to be monitored for suicidal thoughts and behaviors.

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.

February 2024 Ozempic, Mounjaro and Other GLP-1 Lawsuit Update

Lawsuits over Ozempic, Wegovy and Mounjaro currently pending throughout the U.S. court system have focused on the drug makers’ failure to warn about a different side effect, known as gastroparesis or stomach paralysis.

Earlier this month the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order, which assigned all gastroparesis lawsuits involving any GLP1 medications to U.S. District Judge Gene E.K. Pratter in the Eastern District of Pennsylvania.

The JPML’s order came after at least 18 GLP1 lawsuits have been filed in various different federal district courts nationwide, each raising nearly identical allegations that drug makers rushed to get their GLP-1 drugs onto the market amid a rapid increase in popularity without first adequately researching the full safety profile and side effects.

With nearly 2% of the U.S. population having been prescribed these drugs for either diabetes treatment or weight loss, GLP-1 drug lawsuit lawyers anticipate hundreds or even thousands of similar claims are likely to be filed in the coming months and years, in line with the growing popularity of Ozempic, Wegovy and Mounjaro prescriptions.