ReviewBritish journal of clinical pharmacology2015
Adverse drug reactions - examples of detection of rare events using databases.
Review in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 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
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Severe adverse reactions to benzathine penicillin G in rheumatic heart disease: A systematic review and meta-analysis.PloS one · 2025Pooled it
- Leveraging Administrative Health Data to Capture Rare Adverse Drug Reactions: Identifying Pediatric Patients With Trimethoprim-Sulfamethoxazole Acute Respiratory Distress Syndrome.Pharmacology research & perspectives · 2026Article
- Article
- Serious Adverse Events Following COVID-19 Vaccination: A Descriptive Case Series From a Rural Healthcare System.Cureus · 2026Article
- Safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective.British journal of clinical pharmacology · 2025Review
- Hypoglycemia associated with fluoroquinolone: a pharmacovigilance analysis from 2014 to 2023 based on the FDA adverse event reporting system.Frontiers in medicine · 2025Article
- Antipsychotic-Related DRESS Syndrome: Analysis of Individual Case Safety Reports of the WHO Pharmacovigilance Database.Drug safety · 2024Article
- Safety of fluoroquinolones.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2024Review
- Association of 5α-Reductase Inhibitor Prescription With Bladder Cancer Progression in Males in South Korea.JAMA network open · 2023Article
- Rare immune-related adverse events in patients with melanoma: incidence, spectrum, and clinical presentations.Oncoimmunology · 2023Article
- Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data.Revista de saude publica · 2022Article
- The role ofFrontiers in pharmacology · 2022Article
- Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches.Digestive diseases (Basel, Switzerland) · 2020Review
- Pharmacoepidemiology: Using randomised control trials and observational studies in clinical decision-making.British journal of clinical pharmacology · 2019Review
- Evolving role of pharmaceutical physicians in medical evidence and education.Advances in medical education and practice · 2018Review
- Administration of oral fluoroquinolone and the risk of rhegmatogenous retinal detachment: A nationwide population-based study in Korea.PloS one · 2018Article
- Stevens-Johnson syndrome/toxic epidermal necrolysis and erythema multiforme drug-related hospitalisations in a national administrative database.Clinical and translational allergy · 2018Article
- Big data for bipolar disorder.International journal of bipolar disorders · 2016Review
- Medication safety research by observational study design.International journal of clinical pharmacy · 2016Review
- Adverse drug reactions.British journal of clinical pharmacology · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
It is recognised that randomised controlled trials are not feasible for capturing rare adverse events. There is an increasing trend towards observational research methodologies using large population-based health databases. These databases offer more scope for adequate sample sizes, allowing for comprehensive patient characterisation and assessment of the associated factors. While direct causality cannot be established and confounders cannot be ignored, databases present an opportunity to explore and quantify rare events. The use of databases for the detection of rare adverse events in the following conditions, sudden death associated with attention deficit hyperactivity disorder (ADHD) treatment, retinal detachment associated with the use of fluoroquinolones and toxic epidermal necrolysis associated with drug exposure, are discussed as examples. In general, rare adverse events tend to have immediate and important clinical implications and may be life-threatening. An understanding of the causative factors is therefore important, in addition to the research methodologies and database platforms that enable the undertaking of the research.
Indexed as
Identifiers
What OpenQuestion holds
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.