People who take the popular drugs Ozempic, to treat diabetes, and Wegovy, to combat obesity, are slightly less likely to have suicidal thoughts than are not taking them, researchers reported Friday.
Millions of people take Ozempic and Wegovy, considered among the biggest blockbusters in the history of medicine. But last year a European medicines safety agency said it was investigating whether the drugs cause suicidal thoughts. The new study, published in the journal Nature Medicine, was funded by the National Institutes of Health and used a huge population. The findings provide data that can potentially reassure people taking these medications.
Novo Nordisk, maker of the drugs, was not involved in the study and the study researchers had no conflicts of interest.
The researchers used anonymized electronic medical records from a database of 100.8 million people. That allowed them to look at two groups: 240,618 who were prescribed Wegovy or other weight-loss medications, and 1,589,855 who were prescribed Ozempic or other blood sugar-lowering medications. Suicidal thoughts were included in patients’ records as part of routine monitoring of their health.
The researchers compared the incidence of suicidal thoughts in people taking the drugs with the incidence among similar people who were not taking the drugs but were taking other weight-loss and antidiabetic medications. They also asked if there was an increase in the recurrence of suicidal thoughts among those taking the medications and had previously reported suicidal thoughts.
The size of the database allowed the researchers to look at subgroups such as sex, race, and age groups.
“No matter how hard we tried, we didn’t see any increased risk,” said Rong Xu, director of the Center for Artificial Intelligence in Drug Discovery at Case Western Reserve University in Cleveland.
Dr. Xu conceived the study and interpreted the data with Dr. Nora D. Volkow, director of the National Institute on Drug Abuse.
But it was an observational study, so it’s impossible to draw conclusions about cause and effect. These studies can only show associations. “Further studies are absolutely necessary,” Dr. Volkow said.
Dr. Xu, Dr. Volkow and their colleagues decided to continue the research last year. A committee of the European Medicines Agency, a group that evaluates and monitors drug safety, announced in July that it was investigating reports from Iceland that some patients taking Ozempic or Wegovy had said they were thinking about suicide or They were deliberately hurting themselves. . The agency said it had found and was analyzing about 150 such cases.
Dr. Volkow said the suicide risk was possible with the drugs because “other anti-obesity treatments that seemed promising and were investigated in the past were discontinued due to the risk of suicidal behavior.” One example was rimonabant, a drug that was withdrawn before it was sold in the United States.
During clinical trials of Ozempic and Wegovy conducted by Novo Nordisk, no links to suicidal thoughts were observed. However, those trials were not designed to detect rare adverse events that could occur when the drugs are widely used.
But case reports like the ones the European agency relied on are difficult to interpret. Did people have thoughts because of drugs? Or were they having those thoughts for reasons that had nothing to do with drugs? Dr. Volkow said she did not believe anecdotal reports alone proved suicide risk, and the European agency recognized the limitations of her case reports when it began investigating her.
Monika Benstetter, a spokesperson for the European agency, wrote in an email that the safety committee “has identified some issues that need further clarification and has published new lists of questions for companies to address.” She added that the agency’s safety committee would address the issue at a meeting in April.
A spokeswoman for the U.S. Food and Drug Administration said that while the agency continued to monitor the drugs, it still found “that the benefits of these drugs outweigh their risks when used in accordance with FDA-approved labeling.” “.
Ambre James-Brown, a spokeswoman for Novo Nordisk, said, “The study findings support safety data collected from large clinical trial and post-marketing surveillance programs.”
Dr. Xu and Dr. Volkow’s research group completed another study using the same huge database, asking whether Ozempic and Wegovy reduce cravings for cigarettes and alcohol. That study is under review in a journal, Dr. Xu said, adding that the group found that, in this case, the anecdotal reports were correct. In fact, those taking these medications report less interest in drinking and smoking.
