Folks taking the wildly standard medicine Ozempic, to deal with diabetes, and Wegovy, to fight weight problems, are barely much less prone to have suicidal ideas who usually are not taking them, researchers reported on Friday.
Hundreds of thousands of individuals take Ozempic and Wegovy, that are thought-about to be among the many largest blockbusters in medical historical past. However final 12 months a European drug security company mentioned it was investigating whether or not the medicine trigger suicidal ideas. The brand new research, printed within the journal Nature Drugs, was funded by the Nationwide Institutes of Well being and used an enormous inhabitants. The findings present information that 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 data from a database of 100.8 million individuals. That allowed them to take a look at two teams: 240,618 who have been prescribed Wegovy or different weight reduction medicine, and 1,589,855 who have been prescribed Ozempic or different medicines to decrease their blood sugar. Suicidal ideas have been included in sufferers’ data as a part of routine monitoring of their well being.
The investigators in contrast the incidence of suicidal ideas in individuals who have been taking the medicine with the incidence amongst comparable individuals who weren’t taking them however have been taking different weight reduction and anti-diabetes drugs. Additionally they 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 measurement allowed the researchers to take a look at subgroups reminiscent of intercourse, race and age teams.
“Irrespective of how arduous we tried we didn’t see any elevated danger,” mentioned Rong Xu, director of the Middle for Synthetic Intelligence in Drug Discovery at Case Western Reserve College in Cleveland.
Dr. Xu conceived the research and interpreted the information with Dr. Nora D. Volkow, director of the Nationwide Institute on Drug Abuse.
However it was an observational research, so it’s inconceivable to attract conclusions about trigger and impact. Such research can solely present associations. “Extra research are completely wanted,” Dr. Volkow mentioned.
Dr. Xu, Dr. Volkow and their colleagues determined to pursue the analysis final 12 months. A committee of the European Medicines Company, a bunch that evaluates and displays the protection of medication, introduced in July that it was investigating reviews from Iceland that some sufferers taking Ozempic or Wegovy had mentioned that they have been pondering of killing themselves or have been intentionally injuring themselves. The company mentioned it had discovered and was analyzing about 150 such circumstances.
Dr. Volkow mentioned suicide danger was doable with the medicine as a result of “different anti-obesity therapies that regarded promising and have been investigated prior to now have been discontinued because of the danger of suicidal behaviors.” One instance was rimonabant, a drug that was withdrawn earlier than it was ever offered in the USA.
Throughout medical trials of Ozempic and Wegovy by Novo Nordisk, no hyperlinks have been noticed to suicidal ideas. These trials, although, weren’t designed to choose up uncommon antagonistic occasions which may happen when medicine are broadly used.
However the case reviews like those the European company relied on are tough to interpret. Have been individuals having ideas due to the medicine? Or have been they having these ideas for causes that had nothing to do with the medicine? Dr. Volkow mentioned she didn’t assume the anecdotal reviews alone proved the suicide danger, and the European company acknowledged the constraints of its case reviews when it began its investigation.
Monika Benstetter, a spokeswoman for the European company, wrote in an e-mail that the protection committee “has recognized some points that want additional clarification and has issued new lists of inquiries to be addressed by the businesses.” She added that the company’s security committee would tackle the difficulty at a gathering in April.
A U.S. Meals and Drug Administration spokeswoman mentioned that whereas the company was persevering with to observe the medicine, it nonetheless discovered “that the advantages of those drugs outweigh their dangers when they’re used based on the FDA accredited labeling.”
Ambre James-Brown, a Novo Nordisk spokeswoman, mentioned, “the findings within the research help the protection information collected from giant medical trial applications and post-marketing surveillance.”
Dr. Xu and Dr. Volkow’s analysis group has accomplished one other research utilizing the identical large database, asking whether or not Ozempic and Wegovy scale back cravings for cigarettes and alcohol. That research is below evaluate at a journal, Dr. Xu mentioned, including that the group discovered that, on this case, anecdotal reviews have been right. These taking the medicine do, in actual fact, report much less curiosity in ingesting and smoking.