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

Journal of Pharmacology & Pharmacotherapeutics
Caterina PalleriaEmilio Russo

Abstract

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. 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. First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbatio...Continue Reading

Citations

Aug 30, 2014·Expert Opinion on Drug Safety·Christian LeporiniEmilio Russo
Feb 9, 2017·Journal of Chemical Information and Modeling·Eleni Kotsampasakou, Gerhard F Ecker
Jun 28, 2017·Toxicology·Eleni KotsampasakouGerhard F Ecker
Apr 3, 2018·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Katsuhiro Ohyama, Munetoshi Sugiura
Feb 24, 2016·European Journal of Endocrinology·Lars SävendahlOliver Blankenstein
Oct 3, 2018·Pharmacy : Journal of Pharmacy, Education and Practice·Siraj SundaranMohammed Saji Salahudeen
Nov 3, 2015·The Journal of Rheumatology·Megan E B ClowseUma Mahadevan
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Dec 5, 2019·Therapeutic Advances in Vaccines and Immunotherapy·Juny SebastianMadhan Ramesh
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Mar 2, 2021·Journal of Clinical Pharmacy and Therapeutics·Maria Antonietta BarbieriEdoardo Spina
Sep 17, 2021·Drugs -- Real World Outcomes·Maria Antonietta BarbieriEdoardo Spina
Oct 16, 2021·Expert Opinion on Drug Safety·Marta ZuccarelliJohn-Joseph Borg

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