EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk

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The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

The European Medicines Agency (EMA) announced on July 11, 2023 that its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on glucagon-like peptide-1 (GLP-1) receptor agonists, which are used to treat type 2 diabetes and weight loss, after reports were received of suicidal thoughts in patients taking the drug. The agency is analyzing approximately 150 reports of thoughts of self-harm by patients using liraglutide and semaglutide medicines. The review of Ozempic (semaglutide), Saxenda (liraglutide), and Wegovy (semaglutide) began on July 3, 2023 and has been extended to include other GLP-1 receptor agonists.

The review is being performed as a signal procedure, which is information on new adverse events associated with a medicine or a new aspect of a known adverse event. However,

EMA stated in a press release that the drugs are widely used and there is no clear indication that the reports are linked to the medicines or instead to other factors.


“As with all medicines, patients and healthcare professionals are advised to use GLP-1 receptor agonists in accordance with the approved product information. Patients and healthcare professionals should also report suspected side effects to authorities. Information on how to report suspected side effects is available in the package leaflets and on the websites of national medicines authorities,” EMA stated in the press release.

Source: EMA