People who take the popular medications Ozempic, to treat diabetes, and Wegovy, to combat obesity, are slightly less likely to have suicidal thoughts than people who don’t take them, researchers found. reported Friday.
Millions of people take Ozempic and Wegovy, which are considered among the greatest successes in medical history. But last year, a European medicines safety agency said it was investigating whether these drugs cause suicidal thoughts. New study, published in the journal Nature Medicine, was funded by the National Institutes of Health and used by a large population. The results provide data that may reassure people who take these medications.
Novo Nordisk, the manufacturer of the drugs, played no role in the study and the study investigators had no conflict of interest.
Investigators used de-identified electronic health records from a database of 100.8 million people. This allowed them to examine two groups: 240,618 who were prescribed Wegovy or other drugs to lose weight, and 1,589,855 who were prescribed Ozempic or other drugs to lower their weight. blood sugar. Suicidal thoughts were included in patients’ records as part of routine health monitoring.
The investigators compared the incidence of suicidal thoughts in people who took these medications with the incidence in similar people who did not take them but took other weight-loss and antidiabetic medications. They also asked whether there was an increase in recurrence of suicidal thoughts among people taking these medications who had previously reported suicidal thoughts.
The size of the database allowed researchers to examine subgroups such as gender, race and age groups.
“No matter how hard we tried, we didn’t see any increase in risk,” said Rong Xu, director of the Center for Artificial Intelligence for Drug Discovery at Case Western Reserve University in Cleveland.
Dr. Xu designed the study and interpreted the data with Dr. Nora D. Volkow, director of the National Institute on Drug Abuse.
But this was an observational study, so it’s impossible to draw conclusions about cause and effect. Such studies can only show associations. “Further studies are absolutely needed,” Dr. Volkow said.
Dr. Xu, Dr. Volkow and their colleagues decided to continue their research last year. A committee of the European Medicines Agency, a group that evaluates and monitors the safety of medicines, announcement in July, it was investigating reports from Iceland that some patients taking Ozempic or Wegovy had said they were considering suicide or deliberately harming themselves. The agency said it discovered and analyzed about 150 such cases.
Dr. Volkow said the risk of suicide was possible with these drugs because “other anti-obesity treatments that showed promise and were studied in the past have been abandoned because of the risk of unhealthy behaviors.” suicidal.” One example is rimonabant, a drug that was withdrawn from the market before it was even sold in the United States.
In clinical trials of Ozempic and Wegovy by Novo Nordisk, no association with suicidal thoughts was observed. These trials, however, were not designed to detect rare adverse events that can occur when the drugs are widely used.
But case reports like those relied on by the European agency are difficult to interpret. Did people have thoughts because of drugs? Or were they having these thoughts for reasons that had nothing to do with drugs? Dr. Volkow said she did not think anecdotal reports alone proved suicide risk, and the European agency acknowledged the limitations of its case reports when it began its investigation.
Monika Benstetter, a representative of the European agency, wrote in an email that the safety committee “has identified certain issues that require further clarification and has published new lists of questions to be addressed by companies.” She added that the agency’s security committee would address the issue at a meeting in April.
A spokesperson for the U.S. Food and Drug Administration said that while the agency continues to monitor the drugs, it nonetheless finds “that the benefits of these drugs outweigh their risks when used as prescribed.” to FDA-approved labeling.
Ambre James-Brown, a spokesperson for Novo Nordisk, said: “The study results support safety data collected during large clinical trial and post-market surveillance programs.”
Dr. Xu and Dr. Volkow’s research group did another study using the same huge database, asking whether Ozempic and Wegovy reduced cravings for cigarettes and alcohol. That study is being reviewed in a journal, Dr. Xu said, adding that the group found that in this case the anecdotal reports were correct. Those who take these drugs actually report less interest in alcohol and tobacco use.