People who take the wildly popular drugs Ozempic, to treat diabetes, and Wegovy, to fight obesity, are slightly less likely to have suicidal thoughts than those who don’t take them, according to researchers. mentionted the manufacture.
Millions of people take Ozempic and Wegovy, considered among the biggest blockbusters in medical history. But last year, a European drug safety agency said it was investigating whether the drugs trigger suicidal thoughts. New study, published in the journal Nature Medicine, was funded by the National Institutes of Health and used a large population. The findings provide data that may potentially reassure people taking the drugs.
Novo Nordisk, manufacturer of the drugs, had no role in the study and the study investigators had no conflict of interest.
The researchers used anonymized 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 weight-loss drugs and 1,589,855 who were prescribed Ozempic or other drugs to lower their blood sugar. Suicidal ideation was included in patients’ records as part of routine health monitoring.
The researchers compared the incidence of suicidal thoughts in people taking the drugs with the incidence in similar people who were not taking them but were taking other weight loss and antidiabetic drugs. They also asked if there was an increase in the recurrence of suicidal thoughts among those taking the drugs who had previously reported suicidal thoughts.
The size of the database allowed the researchers to examine subgroups such as gender, race, and age groups.
“No matter how hard we tried, we didn’t see an 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 Drs. 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. Such studies can only show correlations. “More studies are definitely needed,” 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 assesses and monitors the safety of medicines, was announced in July that it was investigating reports from Iceland that some patients taking Ozempic or Wegovy had said they were thinking about killing themselves or deliberately harming themselves. The agency said it had found and was analyzing about 150 such cases.
Dr. Volkow said the risk of suicide was possible with the drugs because “other anti-obesity treatments that looked promising and had been investigated in the past were stopped because of the risk of suicidal behaviors.” One example was rimonabant, a drug that was withdrawn before it was ever sold in the United States.
During clinical trials of Ozempic and Wegovy by Novo Nordisk, no links to suicidal thoughts were observed. These trials, however, were not designed to detect rare side effects that may occur when drugs are widely used.
However, case reports such as 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 believe anecdotal reports alone proved suicide risk, and the European agency recognized the limitations of case reports when it began its investigation.
Monika Benstetter, a spokeswoman for the European agency, wrote in an email that the safety committee “identified some issues that need further clarification and issued new lists of questions to be addressed by companies.” He added that the agency’s safety committee would consider the matter at a meeting in April.
A spokeswoman for the US Food and Drug Administration said that while the agency continued to monitor the drugs, it found that the benefits of these drugs outweighed their risks when used according to FDA-approved labeling.
Ambre James-Brown, spokeswoman for Novo Nordisk, said “the study findings support safety data collected from large clinical trial programs and post-marketing surveillance.”
The research team of Dr. Xu and Dr. Volkow completed another study using the same massive 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 team found that, in this case, the anecdotal reports were correct. Those taking the drugs, in fact, report less interest in drinking and smoking.