A large U.S. study found no evidence that taking Ozempic or Wegovy is tied to an increase in suicidal thoughts, researchers reported recently.
Both Ozempic for type 2 diabetes and the obesity treatment Wegovy have the same active ingredient, semaglutide.
The analysis included electronic medical record data from more than 1.8 million patients. Researchers actually found a lower risk of new and recurring 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, which were designed to treat type 2 diabetes. In addition to helping control blood sugar levels, the drugs produce a feeling of fullness.
Concerns over reports of suicidal ideation connected with semaglutide led to an investigation by the European Medicines Agency. The U.S. Food and Drug Administration (FDA) has listed suicidal ideation as a possible safety concern for GLP-1 drugs.
A Reuters examination 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 those reports describe a death by suicide or suspected suicide.
Such events do not prove a connection between a drug and a side effect. But they can signal to officials a need to study a specific risk.
The study appeared online in the journal Nature. It was funded by the U.S. National Institutes of Health. The researchers examined 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 percent of Wegovy users. That is compared to 0.43 percent of users of other drugs that do not belong to the same class as semaglutide.
After taking other risk factors into consideration, the risk of first-time suicidal thoughts was 73 percent lower with Wegovy, the researchers said.
No patient in the Wegovy group reported a suicide attempt, compared to 14 users of the other drugs, the report said.
Among patients with a history of suicidal thoughts, the risk of recurring suicidal thoughts was 56 percent lower with Wegovy than other weight-loss medicines.
Similar patterns were seen for use of Ozempic compared with other diabetes drugs.
The findings were consistent no matter the patients’ sex, age, or ethnicity for both semaglutide types, the researchers found.
Such a study cannot prove that GLP-1 agonists do not increase the risk of suicidal ideation. But the findings may reduce concerns.
The researchers were unable to assess the statistical significance of differences in actual suicide attempts. The researchers noted that suicide attempts are "critically different from suicidal ideations."
Pamela Davis is a professor at Case Western Reserve School of Medicine in Ohio. She was one of the writers of the study. She said the growth in popularity of Ozempic makes it very important “to understand all its potential complications.”
Suggestions that the drug may cause suicidal thoughts are not supported by “this very large and diverse population in the U.S.,” Davis added.
I’m Dan Novak.