EMA seeks more info on potential suicide risk for GLP-1 drugs
01 Dec 2023
The European Medicines Agency’s risk assessment committee on Friday said that it requires further information on the risk of suicidal thoughts and thoughts of self-harm potentially linked to GLP-1 receptor agonistsGLP-1 receptor agonists. The review of the drugs began in July with an initial focus on Novo Nordisk’s medicines containing semaglutide or liraglutide, with it subsequently expanded to include all marketed GLP-1 receptor agonistsGLP-1 receptor agonists.
According to the EMA, its Pharmacovigilance Risk Assessment Committee (PRAC) has now assessed all available evidence from clinical trials, post-marketing surveillance and published literature on reported cases of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonistsGLP-1 receptor agonists. The agency noted that while “no conclusion can be drawn on a causal association,” there are several issues that require clarification from the manufacturers.
Along with Novo Nordisk - which markets semaglutide as Ozempic, Rybelsus and Wegovy, and liraglutide as Saxenda, Victoza and Xultophy – the PRAC will send questions to AstraZeneca, Eli Lilly and Sanofi. The EMA said that it will discuss the review again at its next meeting in April.
The probe was initiated following reports from the Icelandic Medicines Agency of two cases involving Saxenda, and one case involving Ozempic and Wegovy. The review was also based on at least 170 case reports found in the EudraVigilance system.
Meanwhile, in the US, the FDA’s own adverse-event database has reportedly received 265 reports of suicidal thoughts or behaviour in patients taking GLP-1 receptor agonistsGLP-1 receptor agonists since 2010. The agency is currently evaluating the reports – which include 36 deaths from suicide or suspected suicide – before deciding if any action is needed.
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