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.
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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