Folks taking the wildly standard medication Ozempic, to deal with diabetes, and Wegovy, to fight weight problems, are barely much less prone to have suicidal ideas than people who find themselves 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 yr a European drug security company stated it was investigating whether or not the medication trigger suicidal ideas. The brand new examine, printed within the journal Nature Medication, was funded by the Nationwide Institutes of Well being and used an enormous inhabitants. The findings present information which will doubtlessly reassure individuals who take the medication.
Novo Nordisk, maker of the medication, had no position within the examine, and the examine’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 have been prescribed Wegovy or different weight reduction medication, and 1,589,855 who have been prescribed Ozempic or different medicines to decrease their blood sugar. Suicidal ideas have 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 have been taking the medication with the incidence amongst related individuals who weren’t taking them however have been taking different weight reduction and anti-diabetes medicines. In addition they requested if there was a rise within the recurrence of suicidal ideas amongst these taking the medication who had beforehand reported ideas of suicide.
The database’s measurement allowed the researchers to have a look at subgroups similar to intercourse, race and age teams.
“Regardless of how exhausting we tried we didn’t see any elevated threat,” stated Rong Xu, director of the Middle for Synthetic Intelligence in Drug Discovery at Case Western Reserve College in Cleveland.
Dr. Xu conceived the examine and interpreted the info with Dr. Nora D. Volkow, director of the Nationwide Institute on Drug Abuse.
Nevertheless it was an observational examine, so it’s unattainable to attract conclusions about trigger and impact. Such research can solely present associations. “Extra research are completely wanted,” Dr. Volkow stated.
Dr. Xu, Dr. Volkow and their colleagues determined to pursue the analysis final yr. A committee of the European Medicines Company, a bunch that evaluates and displays the protection of medicine, introduced in July that it was investigating studies from Iceland that some sufferers taking Ozempic or Wegovy had stated that they have been pondering of killing themselves or have been intentionally injuring themselves. The company stated it had discovered and was analyzing about 150 such instances.
Dr. Volkow stated suicide threat was doable with the medication as a result of “different anti-obesity remedies that appeared promising and have been investigated up to now have been discontinued because of the threat of suicidal behaviors.” One instance was rimonabant, a drug that was withdrawn earlier than it was ever bought in the US.
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 select up uncommon antagonistic occasions which may happen when medication are broadly used.
However the case studies like those the European company relied on are tough to interpret. Have been individuals having ideas due to the medication? Or have been they having these ideas for causes that had nothing to do with the medication? Dr. Volkow stated she didn’t suppose the anecdotal studies alone proved the suicide threat, and the European company acknowledged the constraints of its case studies 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 handle the difficulty at a gathering in April.
A U.S. Meals and Drug Administration spokeswoman stated that whereas the company was persevering with to watch the medication, it nonetheless discovered “that the advantages of those medicines outweigh their dangers when they’re used in line with the FDA permitted labeling.”
Ambre James-Brown, a Novo Nordisk spokeswoman, stated, “the findings within the examine assist 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 examine utilizing the identical enormous database, asking whether or not Ozempic and Wegovy scale back cravings for cigarettes and alcohol. That examine is underneath assessment at a journal, Dr. Xu stated, including that the group discovered that, on this case, anecdotal studies have been appropriate. These taking the medication do, the truth is, report much less curiosity in consuming and smoking.
