Ozempic and Wegovy users had lower risk of suicidal thoughts in large study

The research, supported by the National Institutes of Health, could reassure some patients after a European drug safety agency raised concerns last year last.

People who take the popular drugs Ozempic, to treat diabetes, and Wegovy, to fight obesity, are slightly less likely to have suicidal thoughts than people who don't take them, researchers reported Friday. Millions of people take Ozempic and Wegovy, which are considered among the biggest hits of the history of medicine. But last year, a European medicines safety agency said it was investigating whether these drugs cause suicidal thoughts. The new study, published in the journal Nature Medicine, was funded by the National Institutes of Health and involved a large population. The results provide data that may reassure people taking these medications.

Novo Nordisk, the maker of the drugs, had no role in the study, and study investigators played no role. conflicts of interest.

Investigators used de-identified electronic health records from a database of 100.8 million people. This allowed them to look at 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 among people taking these drugs with the incidence among similar people who were not taking them but were taking other weight loss and antidiabetic drugs. They also asked whether there was an increase in recurrence of suicidal thoughts among people taking medication who had previously reported suicidal thoughts.

The size of the database allowed researchers to look at subgroups such as gender, race and age groups.

“No matter how hard we try, we have not seen 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 designed 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 is impossible to draw conclusions about cause and effect. Such studies can only show associations. “More studies are absolutely needed,” said Dr. Volkow.

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, announced in July that it was investigating reports from Iceland that some patients taking Ozempic or Wegovy had said they were considering to commit suicide or deliberately injure themselves. . The agency said it has found and is analyzing about 150 such cases.

Dr. Volkow said the risk of suicide was possible with the drugs because "other anti-obesity treatments that showed promise and had been studied in the past have been discontinued due to the risk of suicidal behaviors." . One example is rimonabant, a drug that was withdrawn before it was even sold in the United States.

During the clinical trials of Ozempic and Wegovy by Novo Nordisk, no link was observed. suicidal thoughts. 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 on which the The European agency relied on 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 recognized the limitations of its case reports when it began its investments...