Researchers have found that people who take the popular diabetes drug Ozempic and the obesity-fighting drug Wegoby are slightly more likely to have suicidal thoughts than those who don't take them. low report on friday.
Millions of people have taken Ozempic and Wegovy, and they are considered one of the biggest blockbusters in medical history. But last year, Europe's medicines safety agency announced it was investigating whether the drug causes suicidal thoughts.new studyThe study, published in the journal Nature Medicine, was funded by the National Institutes of Health and used a large population. The findings provide potentially reassuring data for people taking the drug.
The drug's manufacturer, Novo Nordisk, was not involved in the study, and the study's researchers had no conflicts of interest.
The researchers used anonymized electronic health records from a database of 108 million people. This allowed him to study his two groups of 240,618 people who were prescribed Wegovy or other weight loss drugs, and his 1,589,855 people who were prescribed Ozempic or other drugs to lower their blood sugar levels. I did. Suicidal ideation was included in patient records as part of regular health monitoring.
Researchers looked at the incidence of suicidal ideation in people taking the drug and in similar people not taking the drug but taking other weight loss or antidiabetic drugs. The rates were compared. They also asked whether recurrence of suicidal ideation was increased among drug users who previously reported suicidal ideation.
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 an increase in risk,” said Ron Shu, 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.
However, because it was an observational study, it is impossible to draw conclusions about cause and effect. Such studies can only show associations. “Further research is absolutely necessary,” Dr. Borkow says.
Dr. Xu, Dr. Volkow and their colleagues decided last year to continue this research. The committee of the European Medicines Agency, the body that assesses and monitors the safety of medicines, announced The agency announced in July that it was investigating reports from Iceland that some patients taking Ozempic or Wigovy said they were considering suicide or deliberately harming themselves. The agency said it has discovered and is analyzing about 150 such cases.
Dr. Borkow said there was a possible suicide risk with the drug because “other anti-obesity treatments that appeared promising and have been studied in the past have been discontinued due to the risk of suicidal behavior.” One example was rimonabant, a drug that was withdrawn before it could be sold in the United States.
No association with suicidal ideation was observed in Novo Nordisk's clinical trials of Ozempic and Wigovy. However, these trials were not designed to detect rare adverse events that can occur when drugs are widely used.
However, case reports such as those relied on by the European agency are difficult to interpret. Were people thinking because of drugs? Or did they have such thoughts for reasons unrelated to drugs? Dr. Volkow said he did not believe that anecdotal reports alone proved the risk of suicide, and said the European agency was aware of the limitations of anecdotal reports when it began its investigation.
Monica Benstetter, a spokeswoman for the European agency, said in an email that the safety commission “has identified several issues that require further clarification and has issued a new list of questions for companies to address.” . He added that the agency's safety committee will address the issue at its April meeting.
A spokesperson for the U.S. Food and Drug Administration said the agency continues to monitor the drugs but has found that “the benefits of these drugs outweigh the risks when used according to FDA-approved labeling.”
“The study results support the safety data collected from our extensive clinical trial program and post-marketing surveillance,” Novo Nordisk spokesperson Ambre James Brown said in a statement.
Dr. Xu and Dr. Volkow's research group completed another study using the same large database asking whether Ozempic and Wegovy reduce cravings for cigarettes and alcohol. The study is under consideration in a journal, Dr. Xu said, adding that the research group found that the anecdotal reports were correct in this case. In fact, people who take drugs report a decreased interest in drinking and smoking.
