Pharmacological Research 47 (2003) 493–499 Retrospective analysis of adverse drug reactions to bronchodilators observed in two pulmonary divisions of Catanzaro, Italy L. Gallelli, G. Ferreri, M. Colosimo, D. Pirritano, M.A. Flocco, G. Pelaia, R. Maselli, G.B. De Sarro ∗ Department of Experimental and Clinical Medicine, Clinical Pharmacology Unit, University Magna Graecia of Catanzaro, Regional Pharmacovigilance Center, Mater Domini University Hospital, Via T. Campanella 115, 88100 Catanzaro, Italy Accepted 19 December 2002 Abstract We retrospectively analysed the adverse drug reactions (ADRs) associated with bronchodilator therapy and reported over a 7-year period, from January 1995 to December 2001, in clinical notes of two Pulmonary division of “Mater Domini” University Hospital and “Pugliese-Ciaccio” Hospital, both located in Catanzaro, Italy. Bronchodilators were responsible for 45 (18.5%) out of 243 episodes of ADRs. Theophylline was the drug most involved in ADRs (53.4%), and skin was the body system most susceptible to ADRs induced by all bronchodilators (47.7%). We determined that the drug-ADR relationship was certain in 73% of the reports; withdrawal of the suspected drug led to recovery in 86% of cases. In conclusion, this retrospective evaluation demonstrated that bronchodilators are a common cause of ADRs in hospitalised patients and, therefore, drug surveillance can successfully identify adverse events related with drug administration in hospitalised patients. © 2003 Elsevier Science Ltd. All rights reserved. Keywords: Bronchodilators; Adverse drug reactions; Clinical records; Pulmonary; Hospitalised patients 1. Introduction Pharmacovigilance is traditionally concerned with ad- verse drug reactions (ADRs), thus contributing to better understanding the most important characteristics of ADRs and the pathogenic mechanisms involved [1]. Indeed, ADRs represent a common occurrence in medical wards and can be responsible for an increased number and/or duration of hospitalisations [2,3]. Drug-induced adverse events consti- tute an extremely wide and heterogeneous group of com- plaints, symptoms, disorders and syndromes, which share the common feature that at some point in their development a drug has, directly or indirectly, played a role [4]. An ADR can be associated with a significantly prolonged length of stay, increased morbidity, economic burden, and an almost two-fold increased risk of death [5]. Any drug can be able to induce ADRs, which may range from moderate skin man- ifestations (hives) to fatal adverse drug events [6]. In fact, recent studies showed that the most frequently suspected drugs which are considered responsible for, or contributing ∗ Corresponding author. Tel.: +39-096-171-2323; fax: +39-096-177-4424. E-mail address: desarro@unicz.it (G.B. De Sarro). to a fatal outcome were mainly those used to treat chronic pulmonary diseases, such as bronchodilators [6]. Although spontaneous reporting is, among the several dif- ferent methods that can be used to detect ADRs, is the most widely used surveillance system for routinely monitoring these events [7], it alone cannot provide sufficient guaran- tee that a particular adverse event is a true ADR. Therefore, this approach has to be integrated with retrospective data recorded by clinical trials and medical reports, in order to define ADRs which are either not time-related or associated with chronic drug administration [8]. Retrospective studies carried out to investigate ADRs in hospitalised patients could be very useful to improve the health care system with regard to both financial aspects and risk–benefit evaluations. Bet- ter health care system could be achieved by applying this knowledge to the individual patient, thus trying to avoid pos- sible troubles. The magnitude of these problems implies the need of investing sufficient resources in order to implement programs aimed to identify, assess, and manage ADRs [9]. Within this context, the aim of our research was to retro- spectively evaluate, by analysing the clinical features as well as the frequency of ADRs, the role of bronchodilators in such reactions occurring during hospitalisation in two pul- monary divisions of Catanzaro, Italy. 1043-6618/03/$ – see front matter © 2003 Elsevier Science Ltd. All rights reserved. doi:10.1016/S1043-6618(03)00003-3