ReviewBMJ (Clinical research ed.)2006
Case reports of suspected adverse drug reactions--systematic literature survey of follow-up.
Review in BMJ (Clinical research ed.), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 7 of them syntheses 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
33 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Fluoroquinolones and the risk of panic attacks: a systematic review and disproportionality analysis using individual case safety reports from the FDA Adverse Event Reporting System (FAERS) database.The Journal of antimicrobial chemotherapy · 2026Pooled it
- Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature.BMC medicine · 2016Pooled it
- Allopurinol hypersensitivity: a systematic review of all published cases, 1950-2012.Drug safety · 2013Pooled it
- 'Case reporting of rare adverse events in otolaryngology': can we defend the case report?European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2010Pooled it
- Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2009Pooled it
- Systematic reviews of adverse effects: framework for a structured approach.BMC medical research methodology · 2007Pooled it
- Guidelines for submitting adverse event reports for publication.Drug safety · 2007Guideline
- High-Throughput Screening for Prescribing Cascades Among Real-World Angiotensin-Converting Enzyme Inhibitor Initiators.Pharmacoepidemiology and drug safety · 2025Article
- New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?Pharmacy (Basel, Switzerland) · 2024Review
- Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics.Drug safety - case reports · 2017Article
- Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis.BMC medicine · 2015Article
- Pharmacovigilance on the turn? Adverse reactions methods in 2012.The British journal of general practice : the journal of the Royal College of General Practitioners · 2012Article
- Selected national pharmacovigilance websites: an analysis of contents.Drug safety · 2012Article
- The case for the case report: refine to save.Irish journal of medical science · 2011Review
- Re: Hemopericardium following acupuncture?Yonsei medical journal · 2011Article
- Completeness of published case reports on suspected adverse drug reactions: evaluation of 100 reports from a company safety database.Drug safety · 2010Article
- Pattern and quality of scientific communications on drug safety produced by a regional pharmacovigilance center in Nepal.Pharmacy practice · 2010Article
- Assessing long-term drug safety: lessons (re) learned from raptiva.Seminars in cutaneous medicine and surgery · 2010Review
- Time for a new approach to case reports.International journal of surgery case reports · 2010Article
- Time to revisit Dr Finlay's casebook? The unique potential of the general practice case report.Cases journal · 2009Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine whether anecdotal reports of suspected adverse drug reactions are valuable early warning signals.
designSystematic literature survey DATA SOURCES: We evaluated all case reports of adverse drug reactions published in 1997 in five medical journals. Reports were excluded if the adverse reaction had previously been described in earlier publications and was already listed in the product information of the drug reference source (the British National Formulary (BNF) or the Medicines Compendium). We used the Web of Knowledge Citation Index and Medline for 2003 to identify follow-up studies.
main outcome measuresPrimary: the number of suspected adverse reactions subjected to formal validation studies and the findings of these studies. Secondary: the number of instances in which the warning from the case report was incorporated into the product information.
resultsWe evaluated 63 suspected adverse reactions and found that most (52/63, 83%) had not yet been subjected to further detailed evaluation. Data from controlled studies that supported the postulated link between the drug and the adverse event were available in only three cases. Of the 48 agents listed in the drug reference sources, details of the suspected reaction were subsequently added to the Medicines Compendium in 15 instances, and to the BNF in seven instances. In each case, only one reaction had been confirmed.
conclusionsPublished case reports of suspected adverse reactions are of limited value as suspicions are seldom subjected to confirmatory investigation. Furthermore, these alerts are not incorporated into drug reference sources in a systematic manner.
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.