Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System.

Willy Fonseca,Cristina Monteiro,Luís Taborda-Barata

doi:10.3390/ijerph182312411

Abstract

Inhaled medication used for treatment of chronic obstructive lung diseases (asthma, chronic obstructive pulmonary disease-COPD, and Asthma-COPD overlap) may be associated with adverse drug reactions (ADRs). The aim of this study was to characterise spontaneous reports (SRs) of suspected ADRs received by the Portuguese Pharmacovigilance System (PPS), from 2007 to 2017. Methods: Retrospective observational study of SRs associated with single substance and combination inhalers, analysed in terms of pharmacological class of the involved drugs, sex and age range of the involved patients, and seriousness and type of ADRs. Results: 230 SRs were analysed, accounting for a total of 599 suspected ADRs. Inhaled corticosteroid/long-acting beta-2 agonist combination had the highest frequency in SRs (32.2%) and in ADRs (32.7%). There was a slight predominance in men (51.3%) and non-elderly adults were the most affected age group (39.1%). Most SRs were serious (70.4%). In total, “respiratory, thoracic and mediastinal diseases” ADRs were the most reported (19.5%), with “dyspnea” being the most frequent (4.8%). Conclusions: Most SRs were associated with controller medications and were expected. Most ADRs involved non-elderly adults, were serious and of respiratory nature and many were due to overuse of reliever medication.

Highlights

Asthma and chronic obstructive pulmonary disease (COPD) belong to the group of obstructive lung diseases (OLDs)
Taking into account that the use of inhaled therapy for OLDs is widespread, the importance of spontaneous adverse drug reactions (ADRs) reports in Pharmacovigilance and the absence of studies in Portugal, the aim of this study was to analyse the suspected ADRs spontaneously reported to the Portuguese Pharmacovigilance System (PPS) associated with inhaled therapy used in obstructive lung diseases from 2007 to 2017
A retrospective and observational research study based on the collection and analysis of spontaneous reports (SRs) of suspected ADRs associated with inhaled medications used in obstructive lung diseases (COPD, Asthma and asthma-COPD overlap (ACO)), received by the PPS from 2007 to

Summary

Introduction

Asthma and chronic obstructive pulmonary disease (COPD) belong to the group of obstructive lung diseases (OLDs). These are characterised by an increase in resistance to airflow due to partial or complete obstruction in the airways, as well as by a variable inflammatory component [1,2,3]. The asthma-COPD overlap (ACO) entity has been described, it does not yet have a universally accepted definition. ACO more commonly involves patients who are usually older than 40 years and who have a persistent airflow obstruction with both asthma and COPD features [2,4]. ACO is, part of OLDs. The main treatments for OLDs involve medication delivered via inhaler devices

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