Clozapine-induced gastrointestinal hypomotility: UK pharmacovigilance reports, 2018-2022.

IF 3.9 3区医学 Q1 PSYCHIATRY

BJPsych Open Pub Date : 2025-03-31 DOI:10.1192/bjo.2025.29

Robert James Flanagan, Simon Alfred Handley, Charlotte James, Lilly Wells, Susanna Every-Palmer

{"title":"Clozapine-induced gastrointestinal hypomotility: UK pharmacovigilance reports, 2018-2022.","authors":"Robert James Flanagan, Simon Alfred Handley, Charlotte James, Lilly Wells, Susanna Every-Palmer","doi":"10.1192/bjo.2025.29","DOIUrl":null,"url":null,"abstract":"Background: Clozapine-induced gastrointestinal hypomotility (CIGH) can cause constipation, which may progress to ileus, intestinal perforation and other life-threatening conditions. There were at least 527 unique cases of harmful CIGH (172 deaths) assessed by strict criteria in the UK, 1992-2017.Aims: To assess the impact of strengthened warnings about the risks of CIGH, such as those issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) (2017) and the US Food and Drug Administration (2020), on reports of harmful CIGH in the UK.Method: We audited UK MHRA Yellow Card reports recorded as clozapine-related gastrointestinal disorders, 2018-end 2022.Results: Of 335 unique reports (36 fatal, 26 male) that met initial CIGH criteria, there were 129 (22 fatal, 18 male) that met the final CIGH inclusion criteria. Reports of non-fatal CIGH (final criteria) averaged 26 per year (15 in 2022). Deaths averaged four per year (two in 2022). Where data were available the greatest proportion of deaths occurred after 10-14 years of clozapine treatment.Conclusions: Publicity aimed at raising awareness of the problem posed by CIGH has been associated with a reduction in harmful CIGH as reported to the UK MHRA since 2017. Continued vigilance is needed to reduce risk. Stopping smoking may pose a particular risk and should be monitored carefully.","PeriodicalId":9038,"journal":{"name":"BJPsych Open","volume":"11 3","pages":"e79"},"PeriodicalIF":3.9000,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052584/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BJPsych Open","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1192/bjo.2025.29","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Clozapine-induced gastrointestinal hypomotility (CIGH) can cause constipation, which may progress to ileus, intestinal perforation and other life-threatening conditions. There were at least 527 unique cases of harmful CIGH (172 deaths) assessed by strict criteria in the UK, 1992-2017.

Aims: To assess the impact of strengthened warnings about the risks of CIGH, such as those issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) (2017) and the US Food and Drug Administration (2020), on reports of harmful CIGH in the UK.

Method: We audited UK MHRA Yellow Card reports recorded as clozapine-related gastrointestinal disorders, 2018-end 2022.

Results: Of 335 unique reports (36 fatal, 26 male) that met initial CIGH criteria, there were 129 (22 fatal, 18 male) that met the final CIGH inclusion criteria. Reports of non-fatal CIGH (final criteria) averaged 26 per year (15 in 2022). Deaths averaged four per year (two in 2022). Where data were available the greatest proportion of deaths occurred after 10-14 years of clozapine treatment.

Conclusions: Publicity aimed at raising awareness of the problem posed by CIGH has been associated with a reduction in harmful CIGH as reported to the UK MHRA since 2017. Continued vigilance is needed to reduce risk. Stopping smoking may pose a particular risk and should be monitored carefully.

查看原文本刊更多论文

氯氮平诱导的胃肠功能低下：英国药物警戒报告，2018-2022。

背景：氯氮平诱导的胃肠道低动力（CIGH）可引起便秘，并可能发展为肠梗阻、肠穿孔和其他危及生命的疾病。1992年至2017年，根据严格的标准，英国至少有527例有害的CIGH病例（172例死亡）。目的：评估加强CIGH风险警告的影响，例如英国药品和保健产品监管局（MHRA）（2017年）和美国食品和药物管理局（2020年）发布的CIGH风险警告对英国有害CIGH报告的影响。方法：我们审核了2018- 2022年底记录为氯氮平相关胃肠道疾病的英国MHRA黄卡报告。结果：在335例符合初始CIGH标准的独特报告（36例死亡，26例男性）中，有129例（22例死亡，18例男性）符合最终CIGH纳入标准。非致命性CIGH（最终标准）报告平均每年26例（2022年为15例）。平均每年死亡4人（2022年为2人）。在可获得数据的地方，最大比例的死亡发生在氯氮平治疗10-14年后。结论：自2017年向英国MHRA报告以来，旨在提高对CIGH所带来问题的认识的宣传与有害CIGH的减少有关。需要继续保持警惕以降低风险。戒烟可能会带来特别的风险，应该仔细监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

BJPsych Open Medicine-Psychiatry and Mental Health

CiteScore

6.30

自引率

3.70%

发文量

610

审稿时长

16 weeks

期刊介绍： Announcing the launch of BJPsych Open, an exciting new open access online journal for the publication of all methodologically sound research in all fields of psychiatry and disciplines related to mental health. BJPsych Open will maintain the highest scientific, peer review, and ethical standards of the BJPsych, ensure rapid publication for authors whilst sharing research with no cost to the reader in the spirit of maximising dissemination and public engagement. Cascade submission from BJPsych to BJPsych Open is a new option for authors whose first priority is rapid online publication with the prestigious BJPsych brand. Authors will also retain copyright to their works under a creative commons license.