People who take semaglutide a popular diabetes and weight loss drug, are more likely to report suicidal thoughts compared with those taking other medications, according to a new study published Tuesday (20) in JAMA Network Open and based on an international drug safety database.
The finding is the latest shakeup in scientific evidence about the risk of depression and suicide associated with popular prescription drugs — and critics say evidence that these drugs cause mood problems is limited.
Semaglutide is sold under the brand name Ozempic when prescribed for diabetes and Wegovy when prescribed for weight loss. In addition, several companies manufacture compounded forms of the drug. Use of the drug has increased considerably in recent years, and studies have shown more promising effects, including reductions in kidney disease and cancer.
However, suicide has been a long-standing concern with appetite-altering medications. For some people, losing the pleasure and reward of eating creates a dramatic change in mood and can increase the risk of self-harm.
In 2008, the weight-loss drug rimonabant, which worked on the same brain system that makes people hungry when they’re high on marijuana, was withdrawn off the market because it increased the risk of suicide. (The drug was never approved for use in the United States.)
To the patient information about semaglutide already include a warning to watch for signs of depression and suicidal thoughts. However, there is conflicting evidence about the risk of suicidal thoughts and feelings with newer weight-loss medicines, including semaglutide.
Earlier this year, the European Medicines Agency said the available evidence did not show a link between suicide and semaglutide, as well as other weight-loss medications. The U.S. Food and Drug Administration (FDA) has also been investigating the risk of suicide and suicidal thoughts in drugs in the same class as semaglutide and has so far found no increased risk. However, the agency says it cannot rule out a small increase in risk due to the small total number of events in its surveillance systems, and the investigation is still ongoing.
One big study published in January in the journal Nature Medicine found that use of semaglutide was associated with a lower risk of suicidal thoughts compared with people taking different types of weight loss and diabetes medications.
What does the new study say about semaglutide drugs like Ozempic and Wegovy?
THE new study analyzed reports of suicidal thoughts in people taking semaglutide — whether for diabetes or weight loss — in a database maintained by the World Health Organization (WHO) that compiles adverse drug events from 140 countries.
The study authors found 107 reports from patients, out of more than 30,500, who said they had thought about killing themselves while taking semaglutide, and 162 similar reports, out of more than 52,000, in patients taking liraglutide, an injectable diabetes drug that is different from but in the same class as semaglutide. Liraglutide is an older drug, so more people have had experience with it.
The study authors found what they describe as a disproportionate risk of suicidal thoughts in people taking semaglutide, but not in people taking liraglutide. When they compared the reports of suicidal thoughts in people taking semaglutide with the risk reported with all other drugs in the database, they found that the risk was about 45% higher in people taking semaglutide.
The risk was about four times higher in people who also took medications to control depression and anxiety, suggesting that this group may be at even greater risk of mood effects from these medications. When the study authors excluded cases of people taking semaglutide and antidepressants, the association disappeared — suggesting that people taking both medications were driving the risk.
The study authors acknowledge that their research has limitations. But because so many people are taking semaglutide, they believe the results deserve further study and “urgent clarification” about the risk.
Other experts claim that the evidence presented in the study is weak .
“Basically, it’s hard to tell from this study whether it’s the medication that’s causing this or the mood disorder,” says Mahyar Etminan, a drug safety expert at the University of British Columbia in Vancouver who was not involved in the study.
“This paper presents, at best, weak evidence for an association between semaglutide and suicidality,” said Ian Douglas, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine. In a comment given to reporters, Douglas said studies like this are good for generating theories but cannot prove cause and effect.
In a commentary on the study, Francesco Salvo and Jean-Luc Faillie, two French drug safety researchers who were not involved in the research, agree. They say it’s common for drug safety studies to vary in their conclusions depending on the database used and the study methods. Until we have better evidence, they say it’s a good idea to err on the side of caution.
“Depression or suicidality are rare but extremely serious events and need to be prevented and managed as much as possible,” Salvo and Faillie wrote.
Without more precise data, they believe that GLP-1 drugs and other types of appetite suppressants should be prescribed with caution to people with a history of depression or suicidal thoughts. And if patients experience a new episode of depression while taking the drug, they wrote, doctors may want to consider “immediate discontinuation.”
THE CNN Brazil Novo Nordisk, the manufacturer of both drugs, sent a statement on the content of the study. In the document, the company states:
“An independent study, preliminary findings from the U.S. Food and Drug Administration (FDA) and conclusions from a review by the European Medicines Agency (EMA) found no association between the use of GLP-1 agonist medications and an increased risk of suicidal thoughts or actions. These findings are consistent with data collected from the company’s extensive clinical trials, including large outcome studies and observational studies.
The study by Schoretsanitis et al. has several limitations, including lack of data on drug dose and duration of treatment, limited ability to adjust for pre-existing suicidal ideation or pre-existing suicidal depression and alcohol and substance misuse, and a high proportion of use outside the approved indication.
Novo Nordisk prioritizes patient safety and will continue to collaborate closely with the FDA and other regulatory authorities to monitor the safety of all of its GLP-1 agonist medicines. The company stands behind the safety and efficacy of all of its GLP-1 agonist medicines when used as directed and under the care of a licensed healthcare professional. The known risks associated with the use of these medicines are reflected in the product information approved by the FDA, EMA and Anvisa.
Novo Nordisk continuously monitors data from ongoing clinical trials and real-world use of its products, working closely with authorities to ensure patient safety and adequate information for healthcare professionals.”
Editor’s note : If you are having suicidal thoughts, or know someone who is, seek help through the Center for the Valorization of Life (CVV), by contacting volunteers by phone (Call 188), online chat, e-mail or at one of the CVV office addresses (see here).
This content was originally published in Ozempic and Wegovy: new study analyzes risk of suicidal thoughts on the CNN Brasil website.
Source: CNN Brasil
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