Does Ozempic, Wegovy increase the risk of suicidal thoughts? A new NIH study has answers.
A new study found semaglutide, sold as the popular diabetes and weight loss drugs Ozempic and Wegovy, was not linked to an increased risk of suicidal ideation compared with other weight loss drugs.
The report represents the first comprehensive analysis looking at the relationship between suicidal ideation and drugs like Ozempic and Wegovy, manufactured by pharmaceutical giant Novo Nordisk, after anecdotal reports of suicidal thoughts among users drew scrutiny from European and U.S. regulators.
In the study, researchers analyzed over 240,000 electronic health records of U.S. patients who had obesity or overweight and were prescribed semaglutide or another medication for weight loss between June 2021 and December 2022.
The average age of the patients was about 50 and more than 70% of patients were women. Previous research has shown that women are more likely to attempt suicide than men.
Study authors found people prescribed semaglutide for weight loss had a .11% risk of first-time suicidal ideation while patients who took other weight loss drugs reported a .43% risk, according to the report published Friday and by conducted by the National Institutes of Health and Case Western Reserve University
Among those who had a prior history of suicidal thoughts, the study found patients who took semaglutide had a 7% risk of recurring suicidal ideations and patients who took other drugs had a 14% risk.
Researchers determined people who took drugs like Ozempic and Wegovy had a 49% to 73% lower risk of first-time or recurring suicidal ideations than their counterparts taking other medications for weight loss.
"The study does not show that semaglutide is a medication that can prevent suicidal ideation," said Patrick O’Neil, psychologist at the Medical University of South Carolina's weight management center. It shows "that there doesn’t seem to be any added risk among patients taking semaglutide compared to other patients taking other medications for obesity or diabetes."
The new analysis comes amid international concern stirred by anecdotal and case reports that described suicidal thoughts and behaviors in patients taking the medications.
The European Medicines Agency announced in July regulators were reviewing data on the risk of suicidal thoughts and thoughts of self-harm in patients taking GLP-1 receptor agonists, including semaglutides – like Ozempic and Wegovy – and liraglutide, another Novo Nordisk drug under the brand name Saxenda.
The drugs also made it on the radar of U.S. health agencies, motivating the Food and Drug Administration to list suicidal ideation, along with alopecia and aspiration, as serious risks when taking the ubiquitous diabetes and weight loss medications.
The Food and Drug Administration’s Adverse Event Reporting System (FAERS) has received at least 265 reports of suicidal thoughts or behavior in patients taking similar drugs since 2010, according to Reuters analysis. The news organization said 180 of those reports were submitted by Novo Nordisk itself.
After conducting detailed reviews of cases that were reported in the system over the last several months, the FDA determined these reports didn’t show a “clear relationship” between suicidal thoughts and semaglutide, according to a statement Thursday.
However, the agency said it “cannot definitively rule out that a small risk may exist” due to the small number of reports in people using the medication and will continue to “look into the issue.”
Semaglutide took the nation by storm after Wegovy received approval in 2021, promising greater weight loss than other medications on the market. The highest dose has been shown to help people lose about 15% of their body weight when combined with regular exercise and a healthy diet. Another recently approved drug called Zepbound from Eli Lilly showed people lost over 20% of body weight on its highest dose.
In November, a broad, international study also found a 20% reduced risk of serious heart problems such as heart attacks in patients who took Wegovy.
Despite the potential health benefits, a hefty price tag and shortages due to high demand have largely limited access to semaglutide to the wealthy. A monthly supply of Wegovy rings up at about $1,300 and private insurers rarely cover the medications or place strict restrictions on who can access them.
Contributing: Karen Weintraub, Paste BN; Associated Press. Send tips to Adrianna Rodriguez at adrodriguez@usatoday.com