SynthesisBMC medicine2016
Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature.
Synthesis in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 282 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
282 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Allocation of scarce resources in a pandemic: rapid systematic review update of strategies for policymakers.Journal of clinical epidemiology · 2021Pooled it
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- Landscape Analysis of Existing Policies, Laws and Regulations on Antimicrobial Stewardship in 10 Low- and Middle-Income Countries.Antibiotics (Basel, Switzerland) · 2026Article
- Article
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- DeepCYP: an integrated deep learning web server for the holistic "pathway-site product" prediction of CYP450 metabolism.Nucleic acids research · 2026Article
- Novel C3/C28-bis-1,2,4-Triazolyl-sulfanylacetate-betulin Derivatives: Synthesis and Evaluation of Anticancer Potential.International journal of molecular sciences · 2026Article
- Opportunities and challenges for analytical chemists: organ-on-chip devices as new approach methods (NAMs) for identifying potential toxins.The Analyst · 2026Review
- Preclinical evaluation of cysteine protease-inhibitor aloxistatin (E64d) for heart failure therapy.Journal of molecular medicine (Berlin, Germany) · 2026Article
- Beyond Molecular Structures: Investigating Demographic Factors in Drug-Induced Cardiotoxicity Prediction Models.Journal of chemical information and modeling · 2026Article
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- SPECTRA-based Detection of Drug-Induced Hepatotoxicity through Extracellular Vesicle Analysis.Sensors and actuators. B, Chemical · 2026Article
- A Tri-Culture Heart-on-a-Chip Platform With iPSC-Derived Cardiac Cells for Predictive Cardiotoxicity Testing.Advanced healthcare materials · 2026Article
- A Deep Learning-Based Scoring Framework for Large-Scale Multi-Donor Cardiotoxicity Screening.bioRxiv : the preprint server for biology · 2026Article
- Advanced physiological maturation of human iPSC-derived cardiomyocytes using an algorithm-directed optimization of defined media components.Nature communications · 2026Article
- Explainable drug side effect prediction in central neural system via biologically informed graph neural network.Translational psychiatry · 2026Article
- RAG-based architectures for drug side effect retrieval using compact LLMs.Scientific reports · 2026Article
- vToxiNet: a biologically constrained deep learning framework for interpretable prediction of drug-induced hepatotoxicity.bioRxiv : the preprint server for biology · 2026Article
- Liver-on-a-Chip (LoC) Models: Case Studies of Academic Platforms and Commercial Products.Molecular pharmaceutics · 2026Review
- Drugs Withdrawn from the Canadian Market for Safety and Effectiveness Reasons, 1990-2024: A Cross-Sectional Study.Drug safety · 2026Article
222 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
3 authors.
Funding
Abstract
backgroundThere have been no studies of the patterns of post-marketing withdrawals of medicinal products to which adverse reactions have been attributed. We identified medicinal products that were withdrawn because of adverse drug reactions, examined the evidence to support such withdrawals, and explored the pattern of withdrawals across countries.
methodsWe searched PubMed, Google Scholar, the WHO's database of drugs, the websites of drug regulatory authorities, and textbooks. We included medicinal products withdrawn between 1950 and 2014 and assessed the levels of evidence used in making withdrawal decisions using the criteria of the Oxford Centre for Evidence Based Medicine.
resultsWe identified 462 medicinal products that were withdrawn from the market between 1953 and 2013, the most common reason being hepatotoxicity. The supporting evidence in 72 % of cases consisted of anecdotal reports. Only 43 (9.34 %) drugs were withdrawn worldwide and 179 (39 %) were withdrawn in one country only. Withdrawal was significantly less likely in Africa than in other continents (Europe, the Americas, Asia, and Australasia and Oceania). The median interval between the first reported adverse reaction and the year of first withdrawal was 6 years (IQR, 1-15) and the interval did not consistently shorten over time.
conclusionThere are discrepancies in the patterns of withdrawal of medicinal products from the market when adverse reactions are suspected, and withdrawals are inconsistent across countries. Greater co-ordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions would help improve current decision-making processes.
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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.