By Nancy Lapid
(Reuters) - A large U.S. study found no evidence that taking Novo Nordisk (NYSE:NVO)'s Ozempic or Wegovy is tied to an increase in suicidal thoughts, researchers reported on Friday.
Both Ozempic for type 2 diabetes and the obesity treatment Wegovy have the same active ingredient, semaglutide.
Instead, the analysis of electronic medical record data from more than 1.8 million patients found a lower risk of new and recurrent suicidal thoughts in those taking semaglutide compared to those using other medications for weight loss or diabetes.
Semaglutide belongs to a class of drugs known as GLP-1 agonists originally designed for type 2 diabetes. In addition to helping control blood sugar levels, they trigger a feeling of fullness.
Concerns over reports of suicidal ideation associated with semaglutide led to an investigation by the European Medicines Agency, while the U.S. Food and Drug Administration has listed suicidal ideation as a potential safety signal for GLP-1 drugs.
A Reuters review last year found that the FDA had received 265 reports of suicidal thoughts or behavior in patients taking semaglutide or similar medicines since 2010. Thirty-six of these reports describe a death by suicide or suspected suicide.
Such adverse event reports do not prove a link between a drug and a side effect, but can signal to regulators a need to study a specific risk.
For this study, published online in the journal Nature and funded by the U.S. National Institutes of Health, researchers reviewed data on 240,258 U.S. patients prescribed Wegovy or other medications for weight loss and nearly 1.6 million with type 2 diabetes prescribed Ozempic or other treatments.
Researchers compared nearly 53,000 Wegovy patients to the same number of closely matched users of other weight-loss drugs.
They found that during the first six months of use, first-time suicidal thoughts were reported by 0.11% of Wegovy users versus 0.43% of users of bupropion, naltrexone, orlistat, topiramate, phentermine or setmelanotide. None of the other drugs belong to the same class as semaglutide or Eli Lilly (NYSE:LLY)'s Mounjaro and Zepbound, which contain the GLP-1 agonist tirzepatide.
After taking other risk factors into account, the risk of first-time suicidal thoughts was 73% lower with Wegovy, the researchers said.
No patient in the Wegovy group reported a suicide attempt, compared with 14 users of the other drugs, the report said.
Among patients with a history of suicidal ideation, the risk of recurrent suicidal thoughts was 56% lower with Wegovy than with other weight-loss medicines.
Similar patterns were seen for use of Ozempic compared with other diabetes drugs.
The findings were consistent regardless of patients’ sex, age, or ethnicity for both semaglutide formulations, according to the report.
Such a retrospective observational study cannot prove that GLP-1 agonists do not increase the risk of suicidal ideation, but the findings may allay concerns.
Furthermore, the researchers were unable to assess the statistical significance of differences in actual suicide attempts, which they acknowledge are "critically different from suicidal ideations."
“The exploding popularity of this drug makes it imperative to understand all its potential complications,” study coauthor Pamela Davis of Case Western Reserve School of Medicine said in a statement.
“It’s important to know that prior suggestions that the drug might trigger suicidal thoughts is not borne out in this very large and diverse population in the U.S.”