Liang Haiya, Mao Dandan, Zhao Yan, Zhou Rongjing
Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University, Ningbo, Zhejiang, People's Republic of China.
Eur J Clin Pharmacol. 2025 Oct;81(10):1473-1479. doi: 10.1007/s00228-025-03895-7. Epub 2025 Jul 28.
Quetiapine is an atypical second-generation antipsychotic. Diabetic ketoacidosis (DKA) is an acute metabolic complication, most commonly encountered in type 1 diabetes, and it can be life-threatening if not treated promptly. This study aimed to assess quetiapine-associated DKA using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
We performed a retrospective investigation on the FAERS from the first quarter of 2004 to the second quarter of 2024 using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) from the disproportionality analysis. According to the Medical Dictionary for Regulatory Activities (MedDRA) 26.1, preferred terms (PTs) of reports on adverse drug reactions (ADRs) were classified using System Organ Classification (SOC), and filtered based on hyperglycemia and new-onset diabetes mellitus in the Standardized MedDRA Query (SMQ).
We collected 65,536 ADR reports with quetiapine as the primary suspected drug, including 27 system organ classifications. There were 3,046 cases related to DKA, predominantly from the United States, with a slightly higher proportion of females (51.31%) than males (45.63%). The most common severe ADR outcome (539 cases, 17.70%) was hospitalization-initial or prolonged, followed by death (333 cases, 10.93%). Additionally, compared to the other three second-generation antipsychotics (clozapine, olanzapine, and risperidone), quetiapine exhibited a stronger association with DKA (ROR = 31.05, ROR025 = 29.87).
Quetiapine could be associated with DKA; therefore, physicians should be aware of this potentially fatal adverse event. Studies are needed to investigate the matter further.
喹硫平是一种非典型第二代抗精神病药物。糖尿病酮症酸中毒（DKA）是一种急性代谢并发症，最常见于1型糖尿病，如果不及时治疗可能危及生命。本研究旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库评估与喹硫平相关的DKA。
我们使用不成比例分析中的报告比值比（ROR）和比例报告比（PRR），对2004年第一季度至2024年第二季度的FAERS进行了回顾性调查。根据《监管活动医学词典》（MedDRA）26.1，药物不良反应（ADR）报告的首选术语（PTs）使用系统器官分类（SOC）进行分类，并根据标准化MedDRA查询（SMQ）中的高血糖和新发糖尿病进行筛选。
我们收集了65536份以喹硫平为主要疑似药物的ADR报告，包括27个系统器官分类。有3046例与DKA相关，主要来自美国，女性比例（51.31%）略高于男性（45.63%）。最常见的严重ADR结局（539例，17.70%）是初次住院或延长住院时间，其次是死亡（333例，10.93%）。此外，与其他三种第二代抗精神病药物（氯氮平、奥氮平和利培酮）相比，喹硫平与DKA的关联更强（ROR = 31.05，ROR025 = 29.87）。
喹硫平可能与DKA相关；因此，医生应意识到这一潜在致命的不良事件。需要进一步研究以深入调查此事。
