Elsevier

Pharmacological Research

Volume 46, Issue 5, November 2002, Pages 395-400
Pharmacological Research

ADVERSE DRUG REACTIONS TO ANTIBIOTICS OBSERVED IN TWO PULMONOLOGY DIVISIONS OF CATANZARO, ITALY: A SIX-YEAR RETROSPECTIVE STUDY

https://doi.org/10.1016/S1043661802002104Get rights and content

Abstract

We retrospectively analysed adverse drug reactions (ADRs) associated with antibiotic therapy and reported over a 6-year period, from January 1995 to December 2000, in clinical notes of two Pulmonology Units of “Mater Domini” University Hospital and “Pugliese-Ciaccio” Hospital, both located in Catanzaro, Italy.

Antibiotics were responsible for 92 (44.9%) out of 205 episodes of ADRs. In particular, 22 episodes (23.9%) were observed after penicillin G administration, 19 episodes (20.7%) following ceftazidime and cefotaxime administration, 16 episodes (17.4%) after therapy with ampicillin, and 35 reactions (38%) were further reported during treatments with other antibiotics. We determined that the drug–ADR relationship was certain in 63% of the reports; withdrawal of the suspected drug led to recovery in 95% of cases. In conclusion, this retrospective evaluation demonstrated that antibiotics are a common cause of ADRs in hospitalised patients and, therefore, drug surveillance can successfully identify targeted adverse events.

Section snippets

INTRODUCTION

Pharmacovigilance or post-marketing surveillance aims to identify and quantify the risks associated with the use of drugs [1], thus contributing to better understand the most important characteristics of adverse drug reactions (ADRs) and the pathogenic mechanisms involved. Indeed, ADRs represent a common clinical problem and can be responsible for an increased number and/or duration of hospitalisations [2], [3]. An ADR is associated with a significantly prolonged length of stay, increased

METHODS

This study was carried out in two pulmonology divisions of Catanzaro, Italy, located at “Mater Domini” University Hospital and “Pugliese-Ciaccio” Hospital, respectively. We retrospectively analysed the medical records referring to patients who were hospitalised between 1 January 1995 and 31 December 2000. The clinical records of patients receiving antibiotics were reviewed and the following data were obtained: sex and age of the patient, previous history of drug allergy and therapy duration,

RESULTS

During the study period, 4612 clinical records and 18 464 prescriptions were analysed. According to the definition of ADRs and Kramer’s causality algorithm, we reported that within 205 suspects of ADRs (1.11% of total prescriptions), 92 were induced by antibiotics (44.9%). Patients with ADRs induced by antibiotics and by other drugs, did not show any significant difference in the sex ratio (man 53.2% and woman 46.8%; man 56.2% and woman 43.8%, respectively).

The percentage of patients with a

DISCUSSION

An ADR is any response that is unintended and undesired, and that occurs at commonly used doses. The reaction may be idiosyncratic or pharmacologically predictable. Cumulative side effects of medications taken concurrently increase the risk of adverse reactions.

Antibiotics are the most widely used drugs in hospitalised patients. Due to limitations of spontaneous reporting, pharmaco-epidemiological studies may be the only source of information about the benefit–risk profile of medications

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