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WASHINGTON – A large study found no evidence that taking Novo Nordisk's Ozempic or Wigovy was associated with increased suicidal ideation, researchers reported Friday.
The type 2 diabetes drug Ozempic and the obesity drug Wigoby both contain the same active ingredient, semaglutide.
Instead, an analysis of electronic medical record data from more than 1.8 million patients found that patients taking semaglutide had lower rates of new suicidal ideation and relapse compared to those taking weight loss or diabetes medications. The risk of suicidal ideation was found to be low.
Semaglutide belongs to a class of drugs known as GLP-1 agonists, which were originally designed for type 2 diabetes. Not only does it help control blood sugar levels, but it also causes a feeling of fullness.
Concerns over reports of suicidal ideation associated with semaglutide have led to an investigation by the European Medicines Agency, while the US Food and Drug Administration has cited suicidal ideation as a potential safety signal for GLP-1 drugs.
A Reuters investigation last year found that since 2010, the FDA had received 265 reports of suicidal thoughts or behavior in patients taking semaglutide or similar drugs. Thirty-six of these reports listed deaths by suicide or suspected suicide.
Reports of such adverse events do not prove a link between the drug and the side effect, but may indicate to regulatory authorities the need to study specific risks.
In the study, published online in the journal Nature and funded by the National Institutes of Health, researchers compared 240,258 U.S. patients prescribed Wegovy or other drugs for weight loss with Ozempic or other drugs. They looked at data from about 1.6 million people with type 2 diabetes who were prescribed the treatment.
Researchers compared approximately 53,000 Wegovy patients to an equal number of nearly matched users using other weight loss drugs.
Researchers found that during the first six months of use, 0.11% of Wegovy users reported suicidal ideation for the first time, compared with 0.11% of Wegovy users who took bupropion, naltrexone, orlistat, topiramate, phentermine, or setomelanotide. It was found to be 0.43%. None of the other drugs are in the same class as semaglutide or Eli Lilly's Mounjaro and Zepbound, which includes the GLP-1 agonist tirzepatide.
After accounting for other risk factors, the risk of first-time suicidal thoughts was 73% lower with Wegovy, researchers said.
No patients in the Wegovy group reported attempting suicide, compared with 14 users of other drugs, the report said.
It is important to know that previous suggestions that this drug can cause suicidal ideation are not borne out in this very large and diverse population of the United States.
–Pamela Davis, study co-author
In patients with a history of suicidal ideation, the risk of recurrence of suicidal ideation was 56% lower with Wegovy than with other weight loss drugs.
A similar pattern was seen with the use of Ozempic compared with other diabetes drugs.
Results were consistent for both semaglutide formulations, regardless of patient gender, age, or ethnicity, the report said.
Although such retrospective observational studies cannot prove that GLP-1 agonists do not increase the risk of suicidal ideation, this finding may allay concerns.
Furthermore, the researchers were unable to assess the statistical significance of the difference in actual suicide attempts, which the researchers acknowledged are “critically different from suicidal ideation.”
“As this drug has exploded in popularity, it is imperative that we understand all its potential complications,” said study co-author Pamela Davis of Case Western Reserve School of Medicine. said in a statement.
“It is important to know that previous suggestions that this drug can cause suicidal ideation are not borne out in this very large and diverse population of the United States.”
