FDA says preliminary review finds no evidence GLP-1 drugs cause suicidal thoughts
The FDA found no evidence of a causal link between GLP-1 drugs and suicidal thoughts, but the warning stays in the prescribing information while the review continues.
The Food and Drug Administration says a preliminary review found no evidence that GLP-1 receptor agonists — a class that includes Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound — cause suicidal thoughts or actions [1]. The agency also said it cannot definitively rule out that a small risk may exist, and that its review is continuing [1].
The finding was issued in a Drug Safety Communication dated Jan. 11, 2024 [1]. The review covered 13 FDA-approved products in the class [1]. Besides semaglutide (Ozempic, Rybelsus, Wegovy) and tirzepatide (Mounjaro, Zepbound), the class includes Victoza and Saxenda (liraglutide), Trulicity (dulaglutide), Byetta and Bydureon BCise (exenatide), Adlyxin and Soliqua (lixisenatide) and Xultophy (liraglutide plus insulin degludec) [1]. The FDA notes that tirzepatide acts on a second hormone receptor, GIP, in addition to GLP-1 [1].
The agency looked at several kinds of evidence. It reviewed reports of suicidal thoughts or actions filed in the FDA Adverse Event Reporting System, a database of side-effect reports. FDA said the information in those reports was often limited and that such events can be influenced by other potential factors, so the reports did not demonstrate a clear relationship with the medicines [1]. Reviews of clinical trials, including large outcome studies, and of observational studies likewise found no association [1].
The number of suicidal thoughts or actions observed was small both in people taking the drugs and in comparison groups, which is why FDA said it cannot definitively rule out a small risk [1]. The agency is still working on two additional analyses: a meta-analysis, described as a large combined analysis of findings from clinical trials across all GLP-1 RA products, and an analysis of postmarketing data in the Sentinel System, a large network of health insurance claims and patient health records [1].
The current prescribing information for GLP-1 RAs approved to treat patients with obesity or overweight already contains information about the risk of suicidal thoughts and actions [1]. FDA said that labeling is also included on other types of weight-loss medicines and is based on reports of such events seen with a variety of older medicines used or tested for weight loss [1]. The communication did not announce a change to the prescribing information [1].
Why it matters for patients
For people taking these medicines, this update does not change the warning language in the prescribing information, and FDA says its evaluation is not finished [1]. FDA told patients not to stop taking a GLP-1 RA without first consulting their health care professional, because stopping may worsen their condition [1]. The agency advised patients to tell their health care professional about new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior, and pointed to 988, which it said provides free support for people in distress 24 hours a day, seven days a week [1].
FDA directed health care professionals to monitor for these symptoms and to advise patients to report them, consistent with the prescribing information [1]. The agency also said it encourages health care professionals and patients to report side effects involving GLP-1 RAs through its MedWatch program [1].
What happens next
FDA said it will communicate its final conclusions and recommendations after it completes its review or has more information to share [1]. The communication set no date for when the meta-analysis or the Sentinel System analysis will be finished, and no timeline for final conclusions has been reported [1].
Sources
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