The European Medicines Agency also found no evidence to support an association between the GLP-1 receptor and suicidal thoughts.
Two new studies have found that semaglutide (sold under the brand names Ozempic and Wegovy) does not cause a risk of depression and suicide. This comes after health agencies in the United States and Europe said they found no evidence that suicidal thoughts or self-harm are linked to the popular weight-loss and diabetes drug.
In the first study, researchers at the Perelman School of Medicine at the University of Pennsylvania analyzed data from more than 3,300 people who participated in one of four semaglutide clinical trials and who did not have any serious mental disorders. They found that 1% of participants reported suicidal thoughts or behavior during treatment, with no difference between 2.4 milligrams of semaglutide and a placebo.
“The STEP trials provide strong evidence that semaglutide 2.4 mg reduces body weight and improves numerous health complications associated with obesity,” said Thomas Wadden, professor of psychology in psychiatry and former director of the university’s Center for Weight and Eating Disorders.
Earlier this year, the European Medicines Agency said there is no evidence to support a causal association between GLP-1 receptor agonists (this class of drugs) and suicidal thoughts or actions.
However, despite the findings appearing to be “reassuring,” researchers are unsure whether these drugs are safe for those with pre-existing mental health issues. “Our new analysis provides reassurance that the drug, when taken by people without significant mental health issues, does not increase the risk of depression, suicidal thoughts or suicidal behavior,” added Wadden, who has received grants and consulting fees from Novo Nordisk.
The U.S. Food and Drug Administration approved Ozempic in 2017 to treat type 2 diabetes in adults and Wegovy in 2021 for weight loss in adults. They are part of a class of drugs that mimic the hormone GLP-1 to make people feel full and eat less.
The second study also confirms safety
Both studies, published in JAMA Internal Medicine Other researchers have come to the same conclusion about the drug. The second study concluded that GLP-1 drugs did not increase the risk of death by suicide among nearly 125,000 adults in Denmark and Sweden, where data were collected through extensive clinical studies, including large-scale outcome trials and observational studies.
Penn study raises concerns about people with moderate to severe depression
Another study, conducted by the University of Pennsylvania last month, yielded different results. It found that semaglutide users may face a higher risk of suicidal thoughts. The research raised concerns about the exclusion of people with pre-existing mental health problems, such as moderate or severe depression.
Although more than a third of patients had a history of psychiatric disorders in the other study, the researchers only looked at two types of GLP-1 drugs: semaglutide and liraglutide, sold under the brand name Victoza.
However, the scientists believe that the study participants may have “stopped taking GLP-1 medications at the onset of worsening depressive symptoms, before the development of suicidal ideation.”
How do medications work?
Approved by the FDA for weight loss in 2021, Wegovy acts on the central nervous system and carries a warning about suicidal ideation. According to experts, its prescription label also tells doctors to monitor for depression or suicidal thoughts.
Ozempic, a different dose of semaglutide, does not carry that warning, as it is only approved to treat type 2 diabetes, although some doctors prescribe it off-label for weight loss. Semaglutide significantly lowers blood sugar levels and reduces body weight by an average of 15 percent.
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