{
  "abstract": "Introduction The U.S. Food and Drug Administration (FDA) investigated the potential risk of suicidal ideation and behaviors for glucagon-like peptide 1 receptor agonists (GLP-1 RAs) on learning of post-marketing reports of suicidal ideation and behaviors in patients taking GLP-1 RAs. This study assessed a potential association with intentional self-harm comparing GLP-1 RAs to other antidiabetic products.Research design and methods We conducted an active-comparator, new-user cohort study—using FDA’s Sentinel System—with data from October 1, 2015, to September 30, 2023. The study included health plan members ≥18 years old diagnosed with type 2 diabetes, newly initiated GLP-1 RAs (n=1 161 983), sodium-glucose cotransporter-2 inhibitors (SGLT-2is, n=1 081 155), or dipeptidyl peptidase-4 inhibitors (DPP-4is, n=1 396 382), and continuously enrolled in a health plan with medical and drug coverage for ≥183 days. The main outcome was intentional self-harm. We estimated hazard ratios (HR) and 95% confidence intervals (CI) for intentional self-harm events and used inverse probability of treatment weighting of propensity scores to control for confounding.Results The comparator groups had a mean age that was slightly above 60 years and similar percentages of males and females. Adjusted incidence rates of intentional self-harm per 1000 person-years were 1.13 for GLP-1 RAs, 1.22 for SGLT-2is, and 1.37 for DPP-4is. Adjusted HRs indicated no increased risk of intentional self-harm comparing GLP-1 RAs to SGLT-2is (HR 0.93; 95% CI 0.81 to 1.08) or DPP-4is (HR 0.94; 95% CI 0.82 to 1.07). Subgroup analyses by comorbid obesity and diabetes, psychiatric history, prior intentional self-harm, age, and sex yielded similar results.Conclusions The use of GLP-1 RAs did not show increased risk of intentional self-harm compared with SGLT-2is or DPP-4is, which provides some reassurance regarding the safety of GLP-1 RA use in patients with type 2 diabetes.",
  "authors": [
    {
      "affiliations": [
        "Formerly at U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Aida Kuzucan"
    },
    {
      "affiliations": [
        "U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Van Tran"
    },
    {
      "affiliations": [
        "U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Jamal T Jones"
    },
    {
      "affiliations": [
        "U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Sarah K Dutcher"
    },
    {
      "affiliations": [
        "Harvard Pilgrim Health Care Institute LLC, Boston, Massachusetts, USA"
      ],
      "name": "Meg Her"
    },
    {
      "affiliations": [
        "Harvard Pilgrim Health Care Institute LLC, Boston, Massachusetts, USA"
      ],
      "name": "Maria E Kempner"
    },
    {
      "affiliations": [
        "U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Joo-Yeon Lee"
    },
    {
      "affiliations": [
        "Formerly at U.S. Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Andrew Mosholder"
    },
    {
      "affiliations": [
        "Harvard Pilgrim Health Care Institute LLC, Boston, Massachusetts, USA"
      ],
      "name": "Katherine E Round"
    },
    {
      "affiliations": [
        "Harvard Medical School, Boston, Massachusetts, USA"
      ],
      "name": "Sengwee Toh"
    },
    {
      "affiliations": [
        "Harvard Medical School, Boston, Massachusetts, USA"
      ],
      "name": "Jennifer G Lyons"
    }
  ],
  "title": "Association of GLP-1 receptor agonists with intentional self-harm in patients with type 2 diabetes: a Sentinel Distributed Database study",
  "uid": "7fe5dd55-c7ad-519b-b199-c805fa20c72d"
}