"After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies," the EMA said that "no update to the product information is warranted." The drugmakers will continue to monitor these events as part of their pharmacovigilance activities and "report any new evidence on this issue."
Additionally, the EMA said it analysed the results of an electronic health records study, published in Nature Medicine in January, which investigated the incidence of suicidal thoughts in nearly 241,000 patients with overweight and type 2 diabetes treated with semaglutide or other non-GLP-1 receptor agonistsnon-GLP-1 receptor agonists. The study found no causal association between the use of semaglutide and suicidal thoughts. Another recent electronic health records study, conducted by EMA, did not support a causal association between the use of GLP-1 receptor agonists and this risk of suicide-related and self-injury-related events in people with type 2 diabetes.
In January, a preliminary FDA report found no link between GLP-1 receptor agonists and suicidal thoughts or actions.
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