ArticleDrug safety2007
Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore.
Article in Drug safety, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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
32 citing papers in PubMed.
- Association between SGLT2 inhibitors and reporting of phimosis/paraphimosis: a comparative pharmacovigilance analysis of the WHO database.Acta diabetologica · 2026Article
- What Antiepileptics Have the Highest Risk of Parkinsonism? A Disproportionality Analysis in the World Health Organisation Pharmacovigilance Database.Movement disorders clinical practice · 2025Article
- Viral infections and related fatal adverse events associated with complement inhibitors for PNH: a real-world pharmacovigilance analysis in FAERS.Frontiers in pharmacology · 2025Article
- Hypertensive events after the initiation of contemporary cancer therapies for breast cancer control.Cancer medicine · 2023Article
- Defining and measuring meditation-related adverse effects in mindfulness-based programs.Clinical psychological science : a journal of the Association for Psychological Science · 2021Article
- History and Development of TCM Case Report in a Real-World Setting.Evidence-based complementary and alternative medicine : eCAM · 2021Article
- Role of serotonin and norepinephrine transporters in antidepressant-induced arterial hypertension: a pharmacoepidemiological-pharmacodynamic study.European journal of clinical pharmacology · 2020Article
- Completeness of reporting of case reports in high-impact medical journals.European journal of clinical investigation · 2020Article
- How about the reporting quality of case reports in nursing field?World journal of clinical cases · 2019Article
- Interaction between paracetamol and lamotrigine: new insights from the FDA Adverse Event Reporting System (FAERS) database.European journal of clinical pharmacology · 2019Article
- Reporting characteristics of case reports of acupuncture therapy with CARE guidelines.Chinese journal of integrative medicine · 2018Article
- The Current Status of Quality of Reporting in Acupuncture Treatment Case Reports: An Analysis of the Core Journal in Korea.Evidence-based complementary and alternative medicine : eCAM · 2017Article
- Adverse drug reactions.Clinical medicine (London, England) · 2016Review
- Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance.Therapeutic advances in drug safety · 2016Article
- Evidence of Misclassification of Drug-Event Associations Classified as Gold Standard 'Negative Controls' by the Observational Medical Outcomes Partnership (OMOP).Drug safety · 2016Article
- Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database.Drug safety · 2015Article
- Causal assessment of pharmaceutical treatments: why standards of evidence should not be the same for benefits and harms?Drug safety · 2015Article
- The CARE guidelines: consensus-based clinical case reporting guideline development.BMJ case reports · 2013Article
- The CARE guidelines: consensus-based clinical case reporting guideline development.Journal of medical case reports · 2013Article
- The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development.Global advances in health and medicine · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Anecdotal reports of adverse drug reactions are generally regarded as being of poor evidential quality. This is especially relevant for postmarketing drug safety surveillance, which relies heavily on spontaneous anecdotal reports. The numerous limitations of spontaneous reports cannot be overemphasised, but there is another side to the story: these datasets also contain anecdotal reports that can be considered to describe definitive adverse reactions, without the need for further formal verification. We have previously defined four categories of such adverse reactions: (i) extracellular or intracellular tissue deposition of the drug or a metabolite; (ii) a specific anatomical location or pattern of injury; (iii) physiological dysfunction or direct tissue damage demonstrable by physicochemical testing; and (iv) infection, as a result of the administration of an infective agent as the therapeutic substance or because of demonstrable contamination. In this article, we discuss the implications of these definitive ('between-the-eyes') adverse effects for pharmacovigilance.
Indexed as
Identifiers
17696577What 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.