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Study finds higher suicide-related reporting odds for semaglutide and liraglutide

The study compares how often suicide-related reports were filed for three GLP-1 drugs in Europe; it does not measure individual risk or show the drugs cause these events.

By the Semaglutides news desk·

A study of European drug-safety reports found that suicide- and self-injury-related reports were filed more often for the GLP-1 drugs liraglutide and semaglutide than for tirzepatide, but the authors say the pattern does not show that any of the drugs causes these events [1].

The 2026 study, published in Frontiers in Pharmacology, examined 42,941 individual case safety reports from EudraVigilance, the European Union's pharmacovigilance database [1]. The reports covered January 1, 2021, through December 31, 2025, and were included when the drug was listed as suspected and the reason for use was type 2 diabetes or weight management [1]. Most of the reports involved semaglutide, followed by tirzepatide and then liraglutide [1]. Gastrointestinal disorders were the most frequently reported adverse events, followed by injury, poisoning and procedural complications, and general disorders and administration site conditions [1].

Suicide and self-injury events made up a small share of the total. The study counted 37 such cases for liraglutide, 141 for semaglutide and 47 for tirzepatide [1]. To compare the three drugs, the researchers calculated reporting odds ratios, a measure of how large a share of a drug's reports involve a given event. Using tirzepatide as the comparison group, the odds ratio was 2.54 for liraglutide (95% confidence interval 1.60 to 4.01) and 2.69 for semaglutide (95% confidence interval 1.91 to 3.83) [1].

A reporting odds ratio is not a measure of risk to any one person. It compares the mix of reports filed for different drugs in a database that relies on voluntary submissions, which can be incomplete, unverified or influenced by how much attention a drug receives. The authors describe their work as "a comparative analysis of disproportionality" rather than a measure of cause and effect, and they state that spontaneous reporting systems have limitations that require caution in interpreting the results [1].

The paper also notes that European and United States regulatory agencies have so far not confirmed a causal relationship between these drugs and suicidality, and that the new results do not contradict those regulatory conclusions [1]. The authors call for continued post-marketing monitoring as use of these medicines for weight management grows [1].

Why it matters for patients

Millions of adults in the United States take semaglutide or tirzepatide, or have taken liraglutide, for diabetes or weight management, so any signal touching mental health draws attention. This study does not estimate how likely any individual patient is to experience suicidal thoughts or self-injury, and it does not provide rates per number of people using each drug. It has not been reported how the 225 combined suicide- and self-injury-related cases split between diabetes use and weight-management use, how severe they were, or what other medicines or conditions those patients had [1].

Because the data come from EudraVigilance, they reflect reports from Europe, not the United States. Whether US reporting patterns look similar has not been reported in this study. The authors' own conclusion is that the comparison should be read with caution and that the findings do not establish a causal link between GLP-1 and GLP-1/GIP receptor agonists and suicide or self-injury events [1]. The study does not address what patients should do if they notice mood changes, and it does not recommend any change in prescribing.

What happens next

The paper itself announces no new regulatory action and no label change; it ends by saying continued pharmacovigilance is warranted, especially as weight-management use increases [1]. Whether the US Food and Drug Administration or the European Medicines Agency will review these specific findings has not been disclosed, and no timeline for any such review has been reported. The authors declare no commercial or financial relationships that could be considered a conflict of interest [1].

Sources

  1. https://pubmed.ncbi.nlm.nih.gov/42723821/

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