An observational, retrospective, comprehensive pharmacovigilance analysis of hydroxychloroquine-associated cardiovascular adverse events in patients with and without COVID-19

Luo, Maokang; Wu, Bin; Li, Yuwen; Wu, Fengbo

doi:10.1007/s11096-022-01457-w

Cited by 4 publications

(2 citation statements)

References 26 publications

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“…According to a retrospective observational study, COVID-19 patients had significantly higher risks of torsades de pointes and QT prolongation related to hydroxychloroquine treatment than the non-COVID-19 group (OR 3.10, P < 0.001). (23) In addition to concomitant medications, it is worth considering that the risk for QT prolongation is mostly multifactorial, including COVID-19 itself, older age, coexisting cardiovascular disease, and the stage of kidney disease, and each factor's severity may have a synergistic effect. (24) Furthermore, outcomes related to ADR reports resulted in more hospitalizations and lifethreatening conditions during the COVID-19 pandemic compared to 2019.…”

Section: Discussionmentioning

confidence: 99%

The Use and Safety Risk of Repurposed Drugs for COVID-19 patients: Lessons Learned Utilizing the Food and Drug Administration’s Adverse Event Reporting System

Alsuhaibani

Edrees

Alshammari

2022

Preprint

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Objectives: This study was designed to assess the disproportionality analyses of adverse drug reactions (ADRs) related to hydroxychloroquine and remdesivir and how ADR reporting fluctuated during the COVID-19 pandemic. Methods: A retrospective observational study was conducted utilizing the Food and Drug Administrations Adverse Event Reporting System (FAERS) data between 2019 and 2021. The study was conducted in two phases. In the first phase, all reports associated with the drugs of interest were evaluated to assess all related adverse drug reactions. In the second phase, specific outcomes of interest (i.e., QT prolongation and renal and hepatic events) were determined to study their association with the drugs of interest. A descriptive analysis was conducted for all adverse reactions related to the drugs being studied. In addition, disproportionality analyses were conducted to compute the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean. All analyses were conducted using RStudio. Results: A total of 9,443 ADR reports related to hydroxychloroquine; 6,160 (71.49) patients were female, and higher percentage of patients of both sexes were over the age of 65 years. QT prolongation (1.48%), pain (1.38%), and arthralgia (1.25%) were most frequently reported ADRs during the COVID-19 pandemic. The association of QT prolongation with use of hydroxychloroquine was statistically significant (ROR 47.28 [95% CI 35.95-62.18]; PRR 42.41 [95% CI 32.25-55.78]; EBGM 16.08; IC 4.95) compared with fluoroquinolone. The outcome was serious medical events in 48.01% of ADR reports; 27.42% required hospitalization and 8.61% resulted in death. Of 6,673 ADR reports related to remdesivir, 3,928 (61.13%) patients were male. During 2020, the top three ADR reports were elevated liver function tests (17.26%), acute kidney injury (5.95%) and death (2.84%). Additionally, 42.71% of ADR reports indicated serious medical events; 19.69% resulted in death and 11.71% indicated hospitalization. The ROR and PRR of hepatic and renal events associated with remdesivir were statistically significant, (4.81 [95% CI 4.46-5.19] and 2.96 [95% CI 2.66-3.29], respectively. Conclusion: Our study showed that several serious ADRs were reported with the use of hydroxychloroquine, which resulted in hospitalization and death. Trends with the use of remdesivir were similar, but to a lesser extent. Therefore, this study showed us that off-label use should be based on thorough evidence-based evaluation. Keywords: COVID-19, hydroxychloroquine, remdesivir, QT prolongation, FAERS.

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Section: Discussionmentioning

confidence: 99%

The Use and Safety Risk of Repurposed Drugs for COVID-19 patients: Lessons Learned Utilizing the Food and Drug Administration’s Adverse Event Reporting System

Alsuhaibani

Edrees

Alshammari

2022

Preprint

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“…Regrettably, there have already been reports in literature emphasizing the need for enhanced AMS efforts. For instance, a meta-analysis reported an increased prevalence of Multi-Drug Resistant Organisms (MDROs) in COVID-19 wards [ 12 ], as well as an increased prevalence of QTc prolongation in COVID-19 patients secondary to unjustified use of hydroxychloroquine/chloroquine therapy or in cases of drug-drug interactions [ 13 , 14 ]. For the past 2 years, much literature has documented the general roles pharmacists are playing in the ongoing COVID-19 pandemic [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

Pharmacist-driven antimicrobial stewardship interventions in patients with COVID-19: a scoping review

et al. 2023

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Background Coronavirus Disease 2019 (COVID-19) is a highly infectious disease that can be treated with antivirals in addition to other antimicrobials in cases of secondary or concomitant infections. This creates potential for antimicrobials misuse, which increases antimicrobial resistance (AMR). Pharmacists are known to undertake prominent roles in combatting AMR. Aim The aim of this review was to characterize pharmacist-driven interventions that have been performed in patients with COVID-19 globally and describe their impact on antimicrobial use. Method We followed the Joanna Briggs Institutes manual framework for scoping reviews in our study. Studies that reported antimicrobial stewardship (AMS) interventions performed by pharmacists in COVID-19 patients were included. Articles that did not report outcomes or did not mention pharmacists in the intervention were excluded. Restrictions included English-only articles from inception date until June 2022. Articles were searched from four databases. Results Eleven publications were included in the review. The most common AMS intervention was pharmacist-driven interventions reported in 63.2% of all studies, followed by guideline development and application (26.3%), and medication supply coordination (10.5%), respectively. The outcomes of the interventions were difficult to compare but showed a reduction in antimicrobial use and prevention of adverse drug reactions with a relatively high acceptance rate from physicians. Conclusion Pharmacists played an important role in performing AMS-related interventions in COVID-19 patients and helped in the fight against the worsening of AMR during the pandemic. The impact of pharmacist-driven AMS interventions in patients with COVID-19 seemed to be positive and improved outcomes related to antimicrobial use.

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The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System

Alsuhaibani

Edrees

Alshammari

2023

Saudi Pharmaceutical Journal

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An observational, retrospective, comprehensive pharmacovigilance analysis of hydroxychloroquine-associated cardiovascular adverse events in patients with and without COVID-19

Cited by 4 publications

References 26 publications

The Use and Safety Risk of Repurposed Drugs for COVID-19 patients: Lessons Learned Utilizing the Food and Drug Administration’s Adverse Event Reporting System

The Use and Safety Risk of Repurposed Drugs for COVID-19 patients: Lessons Learned Utilizing the Food and Drug Administration’s Adverse Event Reporting System

Pharmacist-driven antimicrobial stewardship interventions in patients with COVID-19: a scoping review

The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration’s Adverse Event Reporting System

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