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People taking the drug behind Novo Nordisk’s NVO-0.98% popular Ozempic were found to report suicidal thoughts at a higher rate than people taking other drugs, according to a new study published Tuesday by JAMA Network Open.
The medication, semaglutide, is sold by the the Danish pharma giant in the United States as Ozempic for diabetes and Wegovy for weight loss. The study raises additional concerns over a possible link between highly-coveted diabetes and weight loss drugs like Ozempic and suicidal ideation.
Earlier this year, both the Food and Drug Administration (FDA) and the European Medicines Agency launched their own investigations into the issue. Both health regulators determined there was no link between popular weight loss drugs and suicidal thoughts.
At the time, the FDA added it could not definitively rule out that “a small risk may exist” and said it would continue monitoring for side effects.
In the new observational study, researchers analyzed adverse drug reactions tracked by a World Health Organization (WHO) database. The analysis found 107 reports of patients taking semaglutide who said they had suicidal thoughts. When compared with all the other drugs in the database, people taking semaglutide had a 45% higher risk of reported suicidal thoughts. The risk was even greater for people taking semaglutide and antidepressants.
However, when researchers excluded patients on antidepressants, the link disappeared. Additionally, patients on semaglutide had a lower rate of suicidal behaviors, like suicide attempts and self-injury, when compared with other drugs in the database.
Novo Nordisk NVO-0.98% told STAT in a statement that “the known risks associated with use of these medicines are reflected in their current FDA- and EMA-approved product labeling.” The company also noted that the new study had limitation since it couldn’t control for outside variable like patients’ diagnoses and medical histories.
The study’s researchers also noted the analysis’s limitations such as missing information. They also wrote that the “inability to infer causality does not allow us to attribute any reactions to the effect of a drug.”
Still, they said their findings warranted “urgent clarification” about the risks of the drug.
In January, a separate study found that people taking semaglutide had lower risk of suicidal thoughts compared to people taking other drugs for the same conditions.