Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two “challenging” case reports

作者：Caterina Palleria, Christian Leporini, Serafina Chimirri, Giuseppina Marrazzo, Sabrina Sacchetta, Lucrezia Bruno, Rosaria M. Lista, Orietta Staltari, Antonio Scuteri, Francesca Scicchitano, Emilio Russo · 发表于：Journal of Pharmacology and Pharmacotherapeutics · 年份：2013 · DOI：10.4103/0976-500x.120955 · 被引用次数：115 · 研究领域：Pharmacovigilance and Adverse Drug Reactions、Drug-Induced Adverse Reactions、Pharmaceutical Quality and Counterfeiting

INTRODUCTION: Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. MATERIALS AND METHODS: We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions. RESULTS: First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. DISCUSSION AND CONC...