ArticleResearch in social & administrative pharmacy : RSAP2021
Safety signals for QT prolongation or Torsades de Pointes associated with azithromycin with or without chloroquine or hydroxychloroquine.
Article in Research in social & administrative pharmacy : RSAP, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.
- Systematic review and meta-analysis of the effectiveness and safety of hydroxychloroquine in treating COVID-19 patients.Journal of the Chinese Medical Association : JCMA · 2021Pooled it
- Efficacy and safety of hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs.Journal of endocrinological investigation · 2021Trial
- Safety of Hydroxychloroquine: What a Dermatologist Should Know.American journal of clinical dermatology · 2025Review
- Hydroxychloroquine and the associated risk of arrhythmias.Global cardiology science & practice · 2024Review
- Hydroxychloroquine in nephrology: current status and future directions.Journal of nephrology · 2023Review
- Treating diabetes with combination of phosphodiesterase 5 inhibitors and hydroxychloroquine-a possible prevention strategy for COVID-19?Molecular and cellular biochemistry · 2023Review
- Hydroxychloroquine, QTc prolongation and risk of torsades de pointes.Archives of medical sciences. Atherosclerotic diseases · 2023Article
- Cardiovascular Risks of Hydroxychloroquine vs Methotrexate in Patients With Rheumatoid Arthritis.Journal of the American College of Cardiology · 2022Article
- Serious Cardiovascular Adverse Events Associated with Hydroxychloroquine/Chloroquine Alone or with Azithromycin in Patients with COVID-19: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS).Drugs - real world outcomes · 2022Article
- Safety of Short-Term Treatments with Oral Chloroquine and Hydroxychloroquine in Patients with and without COVID-19: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Arrhythmogenic mechanisms of interleukin-6 combination with hydroxychloroquine and azithromycin in inflammatory diseases.Scientific reports · 2022Article
- Will Cannabis or Cannabinoids Protect You from SARS-CoV-2 Infection or Treat COVID-19?Medical cannabis and cannabinoids · 2022Article
- Targeting Multiple Signal Transduction Pathways of SARS-CoV-2: Approaches to COVID-19 Therapeutic Candidates.Molecules (Basel, Switzerland) · 2021Review
- A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.Expert review of pharmacoeconomics & outcomes research · 2021Article
- When fear and misinformation go viral: Pharmacists' role in deterring medication misinformation during the 'infodemic' surrounding COVID-19.Research in social & administrative pharmacy : RSAP · 2021Article
- An evaluation of co-use of chloroquine or hydroxychloroquine plus azithromycin on cardiac outcomes: A pharmacoepidemiological study to inform use during the COVID19 pandemic.Research in social & administrative pharmacy : RSAP · 2021Article
- Pharmacy practice research priorities during the COVID-19 pandemic: Recommendations of a panel of experts convened by FIP Pharmacy Practice Research Special Interest Group.Research in social & administrative pharmacy : RSAP · 2021Article
- Rationale of a loading dose initiation for hydroxychloroquine treatment in COVID-19 infection in the DisCoVeRy trial-authors' response.The Journal of antimicrobial chemotherapy · 2021Article
- It is time to consider an anti-inflammatory therapy based on the pathophysiology of COVID-19 infection during the right time window?Archives of medical science : AMS · 2021Article
- Evaluation of the Current Therapeutic Approaches for COVID-19: A Systematic Review and a Meta-analysis.Frontiers in pharmacology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
Background: Combinations of hydroxychloroquine (HCQ) and azithromycin have been promoted as treatments for COVID-19 based on small, uncontrolled clinical trials that have not assessed potential risks. Risks of treatment include QT segment prolongation, Torsades de Pointes (TdP), and death. This comparative pharmacovigilance analysis evaluated the risk of these events. Methods: Data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) (>13 million total reports) were used. Queries extracted reports based on exposures of HCQ/chloroquine (CQ) alone, azithromycin alone, HCQ/CQ + azithromycin, amoxicillin alone, HCQ/CQ + amoxicillin alone. Amoxicillin served as a control. Events of interest included death and TdP/QT prolongation as well as accidents/injuries and depression as control events. Proportional Reporting Ratios (PRR) and 95% confidence intervals (CI) were calculated where a lower limit of the of 95% CI (Lower95CI) value of ≥2.0 is interpreted as a potential safety signal. Results: Lower95CIs for HCQ/CQ alone showed no potential safety signals for TdP/QT prolongation, death, or any of the control events included. The PRRs and 95% CIs for TdP/QT prolongation was 1.43 (1.29-2.59) with HCQ/CQ use alone and 4.10 (3.80-4.42) for azithromycin alone. For the combined HCQ/CQ + azithromycin group, the PRR and 95% CI was 3.77 (1.80-7.87). For the control of amoxicillin, there were no safety signals when used alone or in combination with HCQ/CQ. Conclusions: HCQ/CQ use was not associated with a safety signal in this analysis of FAERS data. However, azithromycin used alone was associated with TdP/QT prolongation events and should be used with caution.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.