(Reuters) – A large U.S. study found no evidence that taking Novo Nordisk’s Ozempic or Wegovy is associated with an increase in suicidal thoughts, researchers reported on Friday.
Both Ozempic for type 2 diabetes and the obesity drug Wegovy contain the same active ingredient, Semaglutide.
Instead, an analysis of electronic patient records of more than 1.8 million patients found a lower risk of new and recurrent suicidal thoughts among those taking Semaglutide compared to those taking other weight loss or diabetes medications.
Semaglutide belongs to a class of drugs known as GLP-1 agonists, originally developed for the treatment of type 2 diabetes. They not only help control blood sugar levels, but also induce a feeling of fullness.
Concerns about reports of suicidal thoughts related to Semaglutide led to an investigation by the European Medicines Agency, while the U.S. Food and Drug Administration listed suicidal thoughts as a potential safety signal for GLP-1 drugs.
A Reuters review last year found that since 2010, the FDA had received 265 reports of suicidal thoughts or behavior in patients taking Semaglutide or similar medications, with 36 of these reports describing death by suicide or suspected suicide.
Such reports of adverse events do not prove a link between a drug and a side effect, but can signal to regulatory authorities that a particular risk needs to be investigated.
For this study, published online in the journal Nature and funded by the U.S. National Institutes of Health, researchers reviewed data from 240,258 U.S. patients prescribed Wegovy or other weight loss medications, and nearly 1.6 million patients with type 2 diabetes prescribed Ozempic or other treatments.
The researchers compared almost 53,000 Wegovy patients with the same number of similar users of other weight loss medications.
They found that during the first six months of use, new suicidal thoughts occurred in 0.11% of Wegovy users, compared to 0.43% of users of Bupropion, Naltrexone, Orlistat, Topiramate, Phentermine, or Setmelanotide. None of the other medications belong to the same class as Semaglutide or Eli Lilly’s Mounjaro and Zepbound, which contain the GLP-1 agonist Tirzepatide.
Taking other risk factors into account, the researchers said the risk of new suicidal thoughts with Wegovy was 73% lower.
No patient in the Wegovy group reported a suicide attempt, compared to 14 users of the other medications, the report said.
Among patients with a history of suicidal thoughts, the risk of recurrent suicidal thoughts with Wegovy was 56% lower than with other weight loss drugs.
Similar patterns were observed with the use of Ozempic compared to other diabetes medications.
The report said the results for both Semaglutide formulations were consistent regardless of the gender, age, or ethnic background of the patients.
Such a retrospective observational study cannot prove that GLP-1 agonists do not increase the risk of suicidal thoughts, but the results can help alleviate concerns.
Additionally, the researchers were not able to assess the statistical significance of differences in actual suicide attempts, which they believe „differ crucially from suicidal thoughts.“
„The exploding popularity of this drug makes it essential to understand all possible complications,“ said study co-author Pamela Davis of Case Western Reserve School of Medicine in a statement. „It’s important to know that previous suspicions that the drug could trigger suicidal thoughts were not confirmed in this very large and diverse population in the United States.“
(Reporting by Nancy Lapid; Editing by Bill Berkrot)