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Results of a review by the European Medicines Agency (EMA) show no evidence that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are linked to suicidal and self-injurious thoughts.
GLP-1 RAs are used for managing blood glucose levels in people with type 2 diabetes mellitus and have also been licensed for use in weight loss treatment.
The review, which the EMA said was triggered by the Icelandic Medicines Agency, started in July 2023, following case reports of suicidal thoughts and thoughts of self-injury from people taking liraglutide and semaglutide medicines.
The EMA said at the time that its Pharmacovigilance Risk Assessment Committee (PRAC) was analysing around 150 reports of suicidal thoughts and thoughts of self-injury.
In November 2023, the committee requested additional data from the marketing authorisation holders for Ozempic (semaglutide; Novo Nordisk), Rybelsus (semaglutide; Novo Nordisk), Wegovy (semaglutide; Novo Nordisk), Victoza (liraglutide; Novo Nordisk), Saxenda (liraglutide; Novo Nordisk), Xultophy (liraglutide/insulin degludec; Novo Nordisk), Byetta (exenatide; AstraZeneca UK — now discontinued), Bydureon (exenatide; AstraZeneca UK), Lyxumia (lixisenatide; Sanofi), Suliqua (insulin glargine/lixisenatide; Sanofi) and Trulicity (dulaglutide; Eli Lilly and Company).
A report from the EMA’s PRAC, published on 12 April 2024, said: “After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC considers that no update to the product information is warranted.”
The PRAC statement said that market authorisation holders would continue to monitor events, including new studies, as part of their pharmacovigilance activities.
In January 2024, the US Food and Drug Administration (FDA) said in a statement that it was “evaluating the need for regulatory action” on GLP-1 RAs, following reports of suicidal ideation linked to the drugs in the United States.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a review in July 2023 into the risk of suicidal thoughts and thoughts of self-harm associated with GLP-1 RAs, including exenatide, liraglutide, lixisenatide, dulaglutide and semaglutide.
According to the MHRA Yellow Card reporting scheme, there have been 28 reports of suicidal and self-injurious behaviour among patients taking semaglutide and 23 reports for patients taking liraglutide.
In a statement following the EMA PRAC’s decision, Alison Cave, chief safety officer at the MHRA, said: “We are currently reviewing safety data on the risk of suicidal thoughts and thoughts of self-harm associated with medicines known as GLP-1 receptor agonists, used for treating both type 2 diabetes and weight loss.
“We will carefully consider all available evidence and communicate any further advice to patients and healthcare professionals as appropriate.”
