Excipient induced allergies in oral medications: unravelling the covert threat – a systematic review

IF 1.8 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL
Shrey Seth, Lipin Lukose, Kamal Sud, Jing Xin Goh, Wubshet Tesfaye, Fatima Small, Sathvik B. Sridhar, Ronald L. Castelino
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Abstract

Excipients have been identified as ‘inert’ substances that often enhance the non-pharmacological aspects of a medication. However, recent clinical evidence elucidates their potential in inducing anaphylaxis and indicates that they are often overlooked as potential allergens in routine clinical practice. The aim of the study was to assimilate published evidence on excipient-induced allergies associated with the use of oral medications and to underline their potential as potent allergens. A systematic literature search of MEDLINE, EMBASE and International Pharmaceutical Abstracts databases was performed for case reports published from inception to June 2024. Studies were excluded if they were animal and laboratory studies or not published in English, full-text articles were unavailable, and they lacked essential information. This systematic review was conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Polyethylene glycol was the most prevalent allergenic excipient, followed by colouring agents. Clinical manifestations exhibited wide variability ranging from mild to life-threatening reactions, and the most common presentations were urticaria and angioedema. Most patients recovered spontaneously after withdrawal of the offending agent with less than half necessitating additional drug interventions and only a single instance of reported fatality, which cannot be attributed to the excipient alone. Despite being labelled as inert, excipients pose a significant threat for the development of allergic reactions. Simple measures such as increased awareness among patients and healthcare professionals, comprehensive history taking, reviewing medication compositions and improved patient awareness regarding potentially allergenic excipients can aid in avoiding these readily preventable reactions.

口服药物中赋形剂引起的过敏:揭开隐藏的威胁-一项系统回顾。
赋形剂被认为是“惰性”物质,通常增强药物的非药理学作用。然而,最近的临床证据阐明了它们诱发过敏反应的潜力,并表明它们在常规临床实践中经常被忽视为潜在的过敏原。该研究的目的是吸收已发表的与口服药物使用相关的赋形剂诱发过敏的证据,并强调它们作为强效过敏原的潜力。系统检索MEDLINE、EMBASE和International Pharmaceutical Abstracts数据库中自成立至2024年6月发表的病例报告。如果研究是动物和实验室研究,或未以英文发表,无法获得全文文章,并且缺乏必要信息,则排除这些研究。本系统评价按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行。聚乙二醇是最常见的致敏辅料,其次是着色剂。临床表现从轻微到危及生命的反应都有很大的差异,最常见的表现是荨麻疹和血管性水肿。大多数患者在停药后自发康复,只有不到一半的患者需要额外的药物干预,只有一例报告的死亡病例,这不能单独归因于辅料。尽管被标记为惰性,赋形剂对过敏反应的发展构成重大威胁。简单的措施,如提高患者和医疗保健专业人员的认识,全面的历史记录,审查药物组合和提高患者对潜在的过敏性赋形剂的认识,可以帮助避免这些容易预防的反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Internal Medicine Journal
Internal Medicine Journal 医学-医学:内科
CiteScore
3.50
自引率
4.80%
发文量
600
审稿时长
3-6 weeks
期刊介绍: The Internal Medicine Journal is the official journal of the Adult Medicine Division of The Royal Australasian College of Physicians (RACP). Its purpose is to publish high-quality internationally competitive peer-reviewed original medical research, both laboratory and clinical, relating to the study and research of human disease. Papers will be considered from all areas of medical practice and science. The Journal also has a major role in continuing medical education and publishes review articles relevant to physician education.
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