FDA’s Preliminary Evaluation Suggests No Increased Risk of Suicidal Ideation With Weight-loss Drugs

The U.S. Food and Drug Administration (FDA) released an update on its ongoing safety review of weight-loss drugs in the glucagon-like peptide-1 receptor agonist (GLP-RA) class, which indicated that the Agency had “not found evidence that use of these medicines causes suicidal thoughts or actions.” Drugs in this class include semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza), which are seeing wider use, including off-label use, to treat obesity.

Yesterday’s report follows an FDA announcement covered in CORRelations last week that the Agency would be exploring this drug class for three complications: suicidal ideation, aspiration, and alopecia.

The updated FDA report is consistent with a Nature Medicine study of the electronic health records of over 100 million patients that came out just after the FDA’s announcement last week. That study concluded that semaglutide (Ozempic, Wegovy) “is not associated with higher risk of suicidal ideations in patients with obesity (or who are overweight) or patients with type 2 diabetes.”

The updated FDA report, dated yesterday, did not comment on the complications of aspiration or alopecia, and did say that “because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue” and that the FDA would release its final conclusions when they have more information to share.

The FDA’s communication further indicated that patients “should not stop taking GLP-1 RAs without first consulting your health care professional, as stopping these medicines may worsen your condition.”