Observational studyDrug safety2021
Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.
Observational study in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- A metaresearch study revealed susceptibility of Covid-19 treatment research to white hat bias: first, do no harm.Journal of clinical epidemiology · 2021Pooled it
- Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.Journal of pharmaceutical policy and practice · 2025Article
- Pharmacovigilance of Drug-Drug Interactions with Nirmatrelvir/Ritonavir.Infectious diseases and therapy · 2024Article
- Reporting of COVID-19 Reinfection and Potential Role of Immunosuppressant/Immunomodulating Agents: A Cross-Sectional Observational Analysis Based on a Spontaneous Reporting Database.Clinical drug investigation · 2022Observational
- Assessment of novel technologies in healthcare - off-label use of drugs and the ethics of implementation and distribution of COVID-19 vaccines.Einstein (Sao Paulo, Brazil) · 2022Article
- The signal pathways and treatment of cytokine storm in COVID-19.Signal transduction and targeted therapy · 2021Review
- Safety Consequences of Off-Label Drugs Used for COVID-19.Drug safety · 2021Article
- Real-world treatment patterns and clinical outcomes for inpatients with COVID-19 in the US from September 2020 to February 2021.PloS one · 2021Article
- Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.Therapeutics and clinical risk management · 2021Article
- Tofacitinib Use in Adults with Chronic Inflammatory Disease During the Severe Acute Respiratory Syndrome Coronavirus 2 Pandemic: What Is Known So Far?Current therapeutic research, clinical and experimental · 2021Article
- Potent Molecular Feature-based Neutralizing Monoclonal Antibodies as Promising Therapeutics Against SARS-CoV-2 Infection.Frontiers in molecular biosciences · 2021Review
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEvidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce.
objectiveThis study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment.
methodsThis retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA
resultsOver 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented.
conclusionsThis pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.
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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.