EMA asked 11 GLP-1 drugmakers for suicidal-thought data in November 2023
European labels stayed unchanged after regulators found no causal link, but the FDA and UK reviews were still open, so US patients have no final domestic answer on the same reports.
In November 2023, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) formally asked the companies behind 11 GLP-1 medicines for extra information on reports of suicidal thoughts and self-harm among people using the drugs [1][2]. The request came midway through a review that had opened in July 2023 and wrapped up the following spring [1].
The medicines involved
The November request covered Ozempic, Rybelsus and Wegovy (semaglutide, Novo Nordisk); Victoza and Saxenda (liraglutide, Novo Nordisk); Xultophy, a liraglutide and insulin degludec combination also from Novo Nordisk; Byetta and Bydureon (exenatide, AstraZeneca UK, with Byetta now discontinued); Lyxumia and Suliqua (Sanofi); and Trulicity (dulaglutide, Eli Lilly) [1][2].
The EMA has said the review was triggered by the Icelandic Medicines Agency and followed case reports involving liraglutide and semaglutide products, among them the weight-loss medicine Wegovy [1]. At the outset, the committee was analyzing around 150 reports of suicidal thoughts and thoughts of self-injury [1].
How the committee ruled
PRAC issued its conclusion on 12 April 2024: the evidence on hand did not support a causal association between dulaglutide, exenatide, liraglutide, lixisenatide or semaglutide and suicidal and self-injurious thoughts and actions [2]. In the committee's words, "no update to the product information is warranted" after it weighed non-clinical studies, clinical trials, post-marketing surveillance data and other available research [1][2].
Two studies carried particular weight. One appeared in the journal Nature Medicine and used a large electronic health records database to compare suicidal ideation in people with overweight or type 2 diabetes treated with semaglutide against those on non-GLP-1 medicines; it found no causal association [2]. The second was run by the EMA itself, also drawing on electronic health records, and looked at suicide-related and self-injury-related events in people with type 2 diabetes; those results did not support causation either [2].
The EMA defines a safety signal as information suggesting a possible causal link, or a new aspect of a known one, between a medicine and an adverse event, which warrants investigation. A signal is a reason to look closely; it is not proof that a drug caused anything [2].
Where other regulators stood
The US Food and Drug Administration said in January 2024 that it was "evaluating the need for regulatory action" on GLP-1 receptor agonists after reports of suicidal ideation linked to the drugs in the United States [1].
Britain's Medicines and Healthcare products Regulatory Agency opened its own review in July 2023, covering exenatide, liraglutide, lixisenatide, dulaglutide and semaglutide [1]. Its Yellow Card reporting scheme lists 28 reports of suicidal and self-injurious behavior among patients taking semaglutide and 23 among those taking liraglutide [1]. Alison Cave, the MHRA's chief safety officer, said the agency was "currently reviewing safety data" and would "carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate" [1].
Why it matters for patients
Nothing changed on European product labels for these medicines because of the review, since the committee decided no update was needed [1][2]. The companies will keep tracking these events and any new publications, and will report fresh evidence through their periodic safety update reports [2].
Whether that carries over to American labels is a separate question, and it has not been answered. The FDA had not announced an outcome when the European review closed, and no US decision on this question has been disclosed [1]. That leaves US patients without a final domestic finding on the same reports.
Tirzepatide, sold as Mounjaro and Zepbound, was not part of the European review, and no equivalent finding on tirzepatide appears in the record [2].
What happens next
Monitoring continues. The companies will flag any new evidence in routine safety reporting [2]. The MHRA has said it will communicate further advice once its review is complete, but it has not given a date [1]. The FDA's next step has not been announced [1].
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Sources
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