ArticleJournal of pharmacology & pharmacotherapeutics2013
Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports.
Article in Journal of pharmacology & pharmacotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 4 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
69 citing papers in PubMed, 4 syntheses or guidelines pooled it, 110 citations in OpenAlex.
- Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.Scientific reports · 2025Pooled it
- An Awareness of Pharmacovigilance Among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy.Current drug safety · 2024Pooled it
- Sports nutrition supplements and adverse events - a meta-epidemiological study of case reports specifically addressing causality assessment.European journal of clinical pharmacology · 2022Pooled it
- Nurses' Knowledge, Attitudes, and Practice in Relation to Pharmacovigilance and Adverse Drug Reaction Reporting: A Systematic Review.BioMed research international · 2021Pooled it
- Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.Drug safety · 2026Review
- Real-time active surveillance for drug-induced Thrombocytopenia: A prospective interventional study.Exploratory research in clinical and social pharmacy · 2026Article
- Drug-specific timing and fatality patterns of EGFR-TKI-associated interstitial lung disease in NSCLC-related JADER reports.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Consciousness Disturbances Reported With Clindamycin Versus Cefazolin in Surgical Patients: A Global Pharmacovigilance Analysis Using VigiBase.Clinical and translational science · 2026Article
- Reply : Primary suspect drugs of cataracts in pediatric patients: FDA adverse events reporting database analysis.Journal of cataract and refractive surgery · 2026Article
- Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority.NPJ digital medicine · 2026Review
- Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2026Article
- A computationally efficient biomedical text processing framework for pharmacovigilance: integrating low-rank adaptation and interpretable AI for adverse drug reaction detection.Medical & biological engineering & computing · 2026Article
- Unveiling the tendon toxicity spectrum of anastrozole, letrozole, and exemestane: a real-world pharmacovigilance study.Frontiers in oncology · 2026Article
- A descriptive, retrospective analysis of the quality of spontaneous adverse event reporting to the Côte d'Ivoire Pharmaceutical and Regulatory Authority and its impact on the causality assessment.Therapeutic advances in drug safety · 2026Article
- Systematic analysis of proton pump inhibitors-related adverse reactions using the FDA adverse event reporting system database.PloS one · 2026Article
- A real-world pharmacovigilance study of adverse events associated with esketamine: disproportionality analysis and detection of potential drug-drug interaction signals.European journal of clinical pharmacology · 2025Article
- Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database.Hematology reports · 2025Article
- Development of a genetic priority score to predict drug side effects using human genetic evidence.Nature communications · 2025Article
- Effectiveness of Transformer-Based Large Language Models in Identifying Adverse Drug Reaction Relations from Unstructured Discharge Summaries in Singapore.Drug safety · 2025Article
- New Function for Safety Signal Monitoring in MID-NETClinical and translational science · 2025Article
9 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems. MATERIALS AND
methodsWe performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions.
resultsFirst, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution. DISCUSSION AND
conclusionHealthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.
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.