Mortality Rate Related to Adverse Drug Reactions in Iraqi Patients: A Study Based on WHO Database

Abstract

Background: Adverse drug reactions (ADRs) are unintended harmful effects caused by medications that can occur at any dose. ADRs are a significant contributor to hospital admissions and are responsible for numerous fatalities, particularly among older adults with multiple chronic illnesses who take multiple medications. Reporting ADRs is critical for identifying the harmful effects of medications and monitoring patients in hospitals. Objective: ADRs have a significant impact on mortality rates, but no previous studies in Iraq have focused on death-related reports. To address this problem, we conducted a study to assess mortality rates associated with ADRs in Iraq and identify the drugs most frequently involved. Methods: We collected the ADR reports of Iraqi patients that were registered as fatal from January 2010 to January 2024 in the World Health Organization (WHO) pharmacovigilance database, VigiBase. The case-non-case method will be used to investigate the reporting risk in Iraq versus the rest of the world. Results: A total of 329 fatal ADRs were found, and the mean age of affected patients was 36 years, with a male-to-female ratio of 1.25:1. Antineoplastic agents ranked first among drugs that caused fatal ADRs (38.4%), and pembrolizumab was the leading active ingredient (27 cases, 6.85%). Conclusions: This study is the first to identify and describe fatal ADRs in Iraq and found them less common in Iraq, and the risk is lower in Iraqi women compared to Iraqi men.