PDF(Pubmed)
Abstract：
Background: The present investigation provides a thorough analysis of adverse drug reactions (ADRs) reported in the Database of the Spanish Pharmacovigilance System (FEDRA) for biologic medications primarily indicated for severe refractory asthma, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Our main objective was to identify ADRs not documented in the drugs\' Technical Sheets (summary of product characteristics, SmPC), potentially indicating unrecognized risks meriting pharmacovigilance attention. Methods: Data spanning from each drug\'s market introduction until 22 January 2024, were analyzed, sourced from direct submissions to the Spanish Pharmacovigilance System, industry communications, and literature reviews. We evaluated notifications impartially to ensure a comprehensive review of all the ADRs associated with these medications. Results: This investigation underlines the critical role of post-marketing surveillance in enhancing patient safety. It emphasizes the necessity for healthcare professionals to report ADRs comprehensively to foster a robust pharmacovigilance system. Furthermore, the study highlights gaps between the reported ADRs and the information provided in SmPCs, signaling potential areas for improvement in drug safety monitoring and regulatory oversight. Conclusions: Finally, these findings may contribute to informed decision making in clinical practice and regulatory policy, ultimately advancing patient care and safety in the management of severe uncontrolled asthma.
摘要：
背景：本调查对西班牙药物警戒系统（FEDRA）数据库中报告的主要用于严重难治性哮喘的生物药物不良反应（ADR）进行了全面分析。包括奥马珠单抗,美波利单抗，瑞利珠单抗，贝那利珠单抗，dupilumab,和Tezepelumab.我们的主要目标是识别药品技术说明书中没有记录的不良反应(产品特征摘要，SmPC),潜在的指示未被识别的风险值得药物警戒注意。方法：分析了从每种药物上市到2024年1月22日的数据，来自西班牙药物警戒系统的直接提交，行业通信，和文献综述。我们公正地评估了通知，以确保对与这些药物相关的所有ADR进行全面审查。结果：这项调查强调了上市后监测在提高患者安全性方面的关键作用。它强调医疗保健专业人员必须全面报告ADR，以建立强大的药物警戒系统。此外，该研究强调了报告的ADR与SmPC中提供的信息之间的差距，为改善药物安全性监测和监管监督的潜在领域发出信号。结论：最后，这些发现可能有助于在临床实践和监管政策中做出明智的决策，最终在严重未控制的哮喘的管理中提高患者护理和安全性。
