Ozempic and Wegovy Users Had Less Risk of Suicidal Thoughts in Large Study

People taking the wildly widespread medicine Ozempic, to deal with diabetes, and Wegovy, to fight weight problems, are barely much less more likely to have suicidal ideas than people who find themselves not taking them, researchers reported on Friday.

Millions of individuals take Ozempic and Wegovy, that are thought-about to be among the many greatest blockbusters in medical historical past. But final 12 months a European drug security company mentioned it was investigating whether or not the medicine trigger suicidal ideas. The new research, revealed within the journal Nature Medicine, was funded by the National Institutes of Health and used an enormous inhabitants. The findings present knowledge which will doubtlessly reassure individuals who take the medicine.

Novo Nordisk, maker of the medicine, had no position within the research, and the research’s investigators had no conflicts of curiosity.

The investigators used anonymized digital well being information from a database of 100.8 million individuals. That allowed them to have a look at two teams: 240,618 who had been prescribed Wegovy or different weight reduction medicine, and 1,589,855 who had been prescribed Ozempic or different medicines to decrease their blood sugar. Suicidal ideas had been included in sufferers’ information as a part of routine monitoring of their well being.

The investigators in contrast the incidence of suicidal ideas in individuals who had been taking the medicine with the incidence amongst related individuals who weren’t taking them however had been taking different weight reduction and anti-diabetes medicines. They additionally requested if there was a rise within the recurrence of suicidal ideas amongst these taking the medicine who had beforehand reported ideas of suicide.

The database’s dimension allowed the researchers to have a look at subgroups akin to intercourse, race and age teams.

“No matter how hard we tried we did not see any increased risk,” mentioned Rong Xu, director of the Center for Artificial Intelligence in Drug Discovery at Case Western Reserve University in Cleveland.

Dr. Xu conceived the research and interpreted the info with Dr. Nora D. Volkow, director of the National Institute on Drug Abuse.

But it was an observational research, so it’s inconceivable to attract conclusions about trigger and impact. Such research can solely present associations. “More studies are absolutely needed,” Dr. Volkow mentioned.

Dr. Xu, Dr. Volkow and their colleagues determined to pursue the analysis final 12 months. A committee of the European Medicines Agency, a bunch that evaluates and displays the protection of medicine, introduced in July that it was investigating stories from Iceland that some sufferers taking Ozempic or Wegovy had mentioned that they had been considering of killing themselves or had been intentionally injuring themselves. The company mentioned it had discovered and was analyzing about 150 such circumstances.

Dr. Volkow mentioned suicide threat was attainable with the medicine as a result of “other anti-obesity treatments that looked promising and were investigated in the past were discontinued due to the risk of suicidal behaviors.” One instance was rimonabant, a drug that was withdrawn earlier than it was ever bought within the United States.

During scientific trials of Ozempic and Wegovy by Novo Nordisk, no hyperlinks had been noticed to suicidal ideas. Those trials, although, weren’t designed to select up uncommon antagonistic occasions that may happen when medicine are broadly used.

But the case stories like those the European company relied on are troublesome to interpret. Were individuals having ideas due to the medicine? Or had been they having these ideas for causes that had nothing to do with the medicine? Dr. Volkow mentioned she didn’t assume the anecdotal stories alone proved the suicide threat, and the European company acknowledged the constraints of its case stories when it began its investigation.

Monika Benstetter, a spokeswoman for the European company, wrote in an electronic mail that the protection committee “has identified some issues that need further clarification and has issued new lists of questions to be addressed by the companies.” She added that the company’s security committee would deal with the problem at a gathering in April.

A U.S. Food and Drug Administration spokeswoman mentioned that whereas the company was persevering with to observe the medicine, it nonetheless discovered “that the benefits of these medications outweigh their risks when they are used according to the FDA approved labeling.”

Ambre James-Brown, a Novo Nordisk spokeswoman, mentioned, “the findings in the study support the safety data collected from large clinical trial programs and post-marketing surveillance.”

Dr. Xu and Dr. Volkow’s analysis group has accomplished one other research utilizing the identical enormous database, asking whether or not Ozempic and Wegovy cut back cravings for cigarettes and alcohol. That research is below evaluation at a journal, Dr. Xu mentioned, including that the group discovered that, on this case, anecdotal stories had been appropriate. Those taking the medicine do, in reality, report much less curiosity in consuming and smoking.