速递｜FDA确认：GLP-1类药物不存在自杀风险！要求删除相关警示标签

Core Viewpoint - The FDA has concluded that there is no increased risk of suicidal thoughts or behaviors associated with GLP-1 receptor agonists, leading to the removal of related warnings from drug labels, which is significant for weight loss and diabetes treatment [5][6][7]. Group 1: FDA Findings - The FDA's decision is based on a comprehensive evaluation of evidence, including a meta-analysis of 91 placebo-controlled clinical trials with a total sample size of 107,910 participants, showing no risk differences in suicidal thoughts or behaviors between GLP-1 treatment and placebo groups [5][6]. - Real-world data from the FDA Sentinel system, involving over 2.24 million type 2 diabetes patients, also indicated that GLP-1 usage is not associated with an increased risk of intentional self-harm [6]. Group 2: Regulatory Implications - The FDA has requested the removal of suicide-related risk statements from the labels of several GLP-1 drugs, including Wegovy, Zepbound, and Saxenda, while emphasizing that healthcare professionals should remain vigilant in assessing patients for mental health issues [7]. - This regulatory decision is expected to have a profound impact on the long-term use of GLP-1 drugs, alleviating concerns for patients and healthcare providers, and supporting broader adoption and insurance negotiations for these medications [7].