TikTok's latest fat-melting "miracle" has come under fire after a new, controversial study linked the weight loss drug to suicidal ideation. The study's authors have urged further investigation into potential side effects, but others are less convinced.
Ozempic is an injectable prescription drug developed to manage blood sugar levels in patients with Type 2 diabetes. However, the drug has risen to recognition thanks to one desirable side effect: weight loss.
The drug is based on a molecule called semaglutide, which mimics the structure of a naturally occurring human hormone called glucagon-like peptide 1 (GLP-1). GLP-1 plays an important role in regulating appetite and blood sugar levels by activating specific receptors involved in these pathways.
Because of the similarities in their structures, semaglutide can also activate these receptors, inducing feelings of fullness while delaying the emptying of our stomach. In other words, semagltuide makes us less hungry and therefore less likely to overeat.
Semaglutide is also used in Ozempic's sister drug, Wegovy, which has been approved by the FDA for chronic weight management. Between the start of 2020 and end of 2022, prescriptions of GLP-1 mimic medications like semaglutide increased by 300 percent across the U.S., according to healthcare analytics firm Trilliant Health.
However, when used as a weight loss drug, semaglutide has been shown to have some uncomfortable side effects. Most studies into these have focused on gut problems, but increasingly, research is finding associations between semaglutide and adverse psychiatric events, including suicidal thoughts.
Previous research, published in the International Journal of Clinical Pharmacy, analyzed 31,444 side effect reports linked to semaglutide, as well as related GLP-1 mimic drugs, between January 2021 and May 2023. 481 of the reports listed adverse psychiatric episodes.
Now, new research published in the journal JAMA Network Open has identified further associations between semaglutide and suicidal thoughts.
In their study, a team analyzed over 28 million reports of suspected adverse drug reactions associated with semaglutide and related GLP-1 mimic drug liraglutide (brand name Sazenda) from around the world, published by the World Health Organization. Of these, 107 cases of suicidal thoughts and/or thoughts of self-harm were reported for patients on semagltuide, while 162 reports were made for patients on liraglutide.
Once other confounding factors and medications were accounted for, only semaglutide continued to show this statistically significant association with suicidal ideation.
"This study using the WHO database found a signal of semaglutide-associated suicidal ideation, which warrants urgent clarification," the authors write.
However, not everyone is convinced by the methods used to reach these conclusions.
"In my view this is not a significant or noteworthy paper, and it has major limitations," Stephen Evans, Emeritus Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a statement.
"This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction," he said. "These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance."
In contrast to these results, research from Case Western Reserve University in Cleveland, Ohio, published in the journal Nature Medicine, found that semaglutide was associated with a lower risk of suicidal ideation.
Stephen Burgess, Group Leader at the MRC Biostatistics Unit at the University of Cambridge, added that the results suggesting an association with suicide ideation may actually just be associated with the dramatic weight loss seen by patients.
"I am concerned that these analyses combine and conflate on-target effects of GLP-1R agonists with the broader consequences of weight loss," Burgess said in a statement. "There are biological effects of the mechanism of action of these drugs. And there is the wider impact of losing as much as 20% of one's bodyweight, as has been seen in trials of these drugs. This is a life-changing intervention that will have largely positive consequences for many. But for others, the impact of losing a large amount of weight could have negative emotional consequences."
Evans said that it was still important for physicians to consider mental health concerns when monitoring their patients.
"There are other grounds, based on previous evidence and with other drugs, for being cautious in the use of semaglutide, and being aware of patients' mental health when prescribing it is sensible, even though semagutide itself seems not to increase mental health problems," he said.
If you or someone you know is considering suicide, please contact the 988 Suicide and Crisis Lifeline by dialing 988, text "988" to the Crisis Text Line at 741741 or go to 988lifeline.org.
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References
Tobaiqy, M., Elkout, H. Psychiatric adverse events associated with semaglutide, liraglutide and tirzepatide: a pharmacovigilance analysis of individual case safety reports submitted to the EudraVigilance database. Int J Clin Pharm 46, 488–495 (2024). https://doi.org/10.1007/s11096-023-01694-7
Wang, W., Volkow, N.D., Berger, N.A. et al. Association of semaglutide with risk of suicidal ideation in a real-world cohort. Nat Med 30, 168–176 (2024). https://doi.org/10.1038/s41591-023-02672-2
Schoretsanitis, G., Weiler, S., Barbui C., Raschi, E., & Gastaldon, C. (2024). Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality. JAMA Network Open, 7(8):e2423385. https://doi.org/10.1001/jamanetworkopen.2024.23385
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