A brand new observational examine discovered that folks taking Ozempic and Wegovy appeared to expertise suicidal ideas at a better charge than folks on different medicine, although specialists raised considerations concerning the methodology and the findings contradict what another research have discovered concerning the class of GLP-1 diabetes and weight problems medicine.
Educational researchers analyzed a World Well being Group database that tracks suspected antagonistic drug reactions, and located that there was a forty five% better charge of stories of suicidal ideas related to semaglutide, the ingredient in Novo Nordisk’s Ozempic and Wegovy, in contrast with all different medicine within the database.
When evaluating semaglutide particularly in opposition to different diabetes and weight problems medicine — together with Farxiga, metformin, and orlistat — the reseachers once more noticed a better charge of suicidal ideation reported for semaglutide, in keeping with the study, revealed Tuesday in JAMA Community Open.
These observations don’t imply that semaglutide triggered suicidal ideas, and the general charge of these ideas occurring was nonetheless small, making up solely 0.3% of all of the antagonistic reactions reported for semaglutide. Moreover, whereas semaglutide was linked to a better charge of suicidal ideas versus different medicine within the database, it was linked to a decrease charge of behaviors resembling suicide makes an attempt and self-injury.
Notably, the researchers didn’t discover a larger charge of suicidal ideas tied to an older and fewer efficient GLP-1 drug from Novo known as liraglutide, the ingredient within the diabetes therapy Victoza and the weight problems remedy Saxenda.
The brand new examine is a part of an rising combined image of whether or not the extremely widespread GLP-1 medicine are linked to a better threat of suicidal ideations. One different observational examine saw an elevated charge related to GLP-1 medicine (although not a causal relationship), whereas other studies have not. The Meals and Drug Administration and the European Medicines Company have regarded into the difficulty, following anecdotal stories of suicidal ideas, however they to this point haven’t discovered proof of a causal hyperlink.
Some weight problems medicine that got here earlier than the GLP-1 therapies had been related to a better threat of suicidal ideations, main medical doctors and regulators to be careful for the same phenomenon when evaluating new weight problems medicine. The label for Wegovy — which is authorized for weight problems — already warns medical doctors to watch sufferers for suicidal ideas; the label for Ozempic — authorized for diabetes — doesn’t.
In a press release, Novo mentioned, “the identified dangers related to use of those medicines are mirrored of their present FDA- and EMA-approved product labeling.” The corporate mentioned it stands by the security and efficacy of its GLP-1 medicine once they’re used as indicated, and it continues to collaborate with regulators to watch the security of its therapies.
Novo, in addition to exterior specialists, famous that the brand new examine is restricted because it doesn’t management for variables resembling how nicely sufferers adhered to therapy and sufferers’ diagnoses and medical histories.
Rodrigo Mansur, an assistant professor of psychiatry on the College of Toronto who wasn’t concerned within the examine, mentioned this concern wants additional examine and it’s doable that there’s a particular subset of sufferers who may be vulnerable to suicidal ideas when taking the medicine, and never your entire inhabitants.
On the identical time that regulators are trying into the difficulty, researchers are additionally inspecting a distinct potential impact of GLP-1 medicine — whether or not they would possibly truly assist deal with psychological well being problems. Mansur is operating a clinical trial to see if semaglutide can enhance cognitive operate in folks with weight problems and main despair.
He mentioned it’s not inconceivable that GLP-1 medicine profit sure folks with psychological well being problems whereas growing dangers for some others — a lot in the way in which that customary antidepressants may be useful for many individuals however may improve the chance of suicidal considering in others.
In a press release, the FDA mentioned that it “routinely evaluates particular person antagonistic occasion stories and antagonistic occasion stories from the revealed literature for all authorized medicine.”
“Generally,” the company mentioned, “the FDA doesn’t touch upon third-party analysis or particular person stories however could consider them as a part of the physique of proof to additional our understanding a couple of specific concern and help in our mission to guard public well being.”
Within the new examine, the reseachers discovered that there was a better charge of suicidal ideas reported notably by sufferers who had been taking each semaglutide and antidepressants — better than 4 occasions the speed for different medicine within the database. When researchers excluded these sufferers from their evaluation, semaglutide was not linked to a better charge of suicidal ideations.
There are lots of doable explanations for this discovering. It may very well be that the mix of semaglutide with antidepressants will increase the chance of suicidal considering. It is also that when the folks taking each medicine had been excluded from the evaluation, the pattern measurement was too small to carry out significant statistical analyses.
Or, it might level to a confounding variable — it’s doable that folks on semaglutide had been already at larger threat of despair and suicidal ideations even with out semaglutide, as diabetes and weight problems are circumstances that improve the chance of despair.
Rong Xu, a professor of biomedical informatics at Case Western Reserve College who was not concerned within the examine, mentioned over e-mail that “the database and methodology have limitations, that are all associated to unmeasured or uncontrolled confounders.”
Xu mentioned the WHO database used on this new examine doesn’t embody complete data on sufferers’ demographics, way of life components, and medical historical past, that are all potential confounders that aren’t absolutely accounted for within the analysis. Xu had led a different study that didn’t discover a hyperlink between GLP-1 medicine and suicidal ideations, utilizing a distinct database.
Consultants additionally questioned whether or not it’s the medicine themselves or the burden loss that may result in suicidal considering. Every time an individual loses a big quantity of weight, they’re going by way of a big life change that might have an effect on their psychological well being. Or, if sufferers predict to lose plenty of weight, however don’t, the frustration could worsen their psychological well being as nicely, notably since semaglutide’s efficacy has been highlighted a lot within the media.
Stephen Burgess, group chief on the MRC Biostatistics Unit at College of Cambridge who was not concerned within the examine, mentioned in a press release that “the impression of shedding a considerable amount of weight might have adverse emotional penalties. If a person thinks that dropping pounds is the important thing to happiness, however dropping pounds doesn’t convey happiness, might this result in despair and suicidal ideation?”
“We have to perceive whether or not these outcomes symbolize a particular side-effect of those medicine, or an unusual however tragic consequence of some people’ weight reduction journey,” he added.
Should you or somebody you realize could also be contemplating suicide, contact the 988 Suicide & Disaster Lifeline: name or textual content 988 or chat 988lifeline.org. For TTY customers: Use your most well-liked relay service or dial 711 then 988.
