Analysis of hydroxychloroquine adverse events in COVID-19 patients reported throughout Iraqi pharmacovigilance center in VigiBase™: A study based on WHO database

Abstract

Background: Hydroxychloroquine is a long-used medication, most commonly used to treat and prevent malaria, that also has anti-inflammatory and antiviral characteristics. Therefore, specialists have shown interest in the underlying mechanism of its antiviral activity. In vitro experiments have demonstrated its efficiency against SARS coronavirus, and in vitro and in vivo research on coronavirus disease 2019 (COVID-19) is being conducted. We aimed to investigate reports on adverse events of hydroxychloroquine submitted to the Iraqi Pharmacovigilance Centre and compare the incidence of these reported adverse events in Iraq to globally reported cases during the COVID-19 pandemic in 2020 using information component (IC)025 values. Methods: The reported adverse events of hydroxychloroquine to the national Pharmacovigilance database, VigiBase™ a WHO global database of reported potential side effects of medicinal products, were investigated qualitatively (age, sex, and severity) and quantitatively (using IC025) as a measure of the existence of new/altered safety information associated with hydroxychloroquine. Results: A total of 132 reports were found, with women representing 37.1% and men representing 60.6% of cases, while the rest were unidentified, with the predominant age groups ranging from 18–44 years old accounting for 47.4% of cases. The most reported adverse events were upper (17%) and lower abdomen pain (21%), nausea (14%), diarrhea (13%), and electrocardiogram (ECG) QT prolongation (13%). There were 44 different drug-adverse reaction pairings in which the adverse reaction reports included more than one event. The IC025 value for the most widely reported adverse events showed a positive comparable value for upper (2/0.3) and lower abdominal pain (1.8/-0.0), palpitation (1.6/-0.4), and dyspepsia (1.1/0.6). There was a decreased value for IC025 in cases of ECG QT prolongation (3.5/5), diarrhea (0.3/0.8), abdominal discomfort (0.1/2), and oral fungal infection (-0.4/0.6). Conclusions: The IC025 helped determine the higher reporting rate of adverse events compared to the average global rates.