Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

Abstract

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions. Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

Keywords

• Docetaxel, Pharmacovigilance, Adverse drug reactions, Iraqi pharmacovigilance center, Anti-Cancers.