ArticleInvestigative radiology2018
10 Years of Nephrogenic Systemic Fibrosis: A Comprehensive Analysis of Nephrogenic Systemic Fibrosis Reports Received by a Pharmaceutical Company from 2006 to 2016.
Article in Investigative radiology, 2018. 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.
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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.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Rationales for Non-standard GBCA Dosing-Low?-High?-When? and Why?: A Literature-based Study.Investigative radiology · 2026Pooled it
- Gadolinium-Based Contrast Agents and the Theater of Safety.Clinical journal of the American Society of Nephrology : CJASN · 2026Article
- Use of gadolinium-based contrast agents in head and neck cancer diagnosis, staging, and monitoring: current applications and future perspectives.European radiology · 2026Review
- Clinical Safety of Gadoxetate Disodium: Insights From 20 Years of Use and More Than 12 Million Administrations.Investigative radiology · 2026Article
- Gadolinium toxicity: mechanisms, clinical manifestations, and nanoparticle role.Archives of toxicology · 2025Review
- Gadolinium and Kidney Disease: Should We Still Be Cautious?Clinical journal of the American Society of Nephrology : CJASN · 2025Article
- DCE-MRI Detects OATP-expressing Transplanted Cells Using Clinical Doses of Gadolinium Contrast Agent.Molecular imaging and biology · 2025Article
- Safe and optimized use of gadolinium-based contrast agents in neuroimaging.European radiology · 2024Article
- Ten years of gadolinium retention and deposition: ESMRMB-GREC looks backward and forward.European radiology · 2024Review
- How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol.Pediatric radiology · 2022Review
- An NMR relaxometry approach for quantitative investigation of the transchelation of gadolinium ions from GBCAs to a competing macromolecular chelator.Scientific reports · 2021Article
- Defining the conditions for the development of the emerging class of FeChemical science · 2021Article
- Utility of Contrast-Enhanced T2 FLAIR for Imaging Brain Metastases Using a Half-dose High-Relaxivity Contrast Agent.AJNR. American journal of neuroradiology · 2021Article
- Use of Gadolinium-Based Contrast Agents in Patients with Severe Renal Impairment. Absence of Risk Versus Caution: A Nephrologist's Perspective.Kidney360 · 2020Article
- Safety of gadoterate meglumine in children younger than 2 years of age.Pediatric radiology · 2020Article
- Updated guidelines for intravenous contrast use for CT and MRI.Emergency radiology · 2020Review
- [Magnetic resonance imaging of the brain in neonates and infants].Der Radiologe · 2019Article
- Gadolinium-based contrast agents: why nephrologists need to be concerned.Current opinion in nephrology and hypertension · 2019Review
- Gadobutrol: A Review in Contrast-Enhanced MRI and MRA.Clinical drug investigation · 2018Review
- Nanoparticle Contrast Agents for Photon-Counting Computed Tomography: Recent Developments and Future Opportunities.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this study was to critically assess the evaluation and categorization process for nephrogenic systemic fibrosis (NSF) based on reports received by Bayer from 2006 to 2016. MATERIALS AND
methodsA total of 779 NSF reports received by Bayer globally from 2006 to 2016 were included in the analysis. Arlington Medical Resources provided gadolinium-based contrast agent (GBCA) market share. Reports were conservatively categorized based on the Cowper/Girardi criteria. A statistical model simulated the impact of market share and market introduction on the number of unconfounded reports.
resultsFor all reports, reported onset of disease ranged from 1996 and 2012. Of 779 reports, 325 involved a Bayer product only, 208 involved only products from other companies (or unknown GBCA), and 246 involved both Bayer and non-Bayer products. Most of all reports (86%) originated from the United States.Through 2006, Magnevist and Omniscan dominated the US market (>80% combined market share). All other GBCAs with fewer NSF reports comprised the remaining combined market share of less than 20% or were introduced after May 2007, after safety recommendations came into effect.A total of 563 reports (220 single-agent and 343 multiagent reports) involved Magnevist. In at least 150 of the 343 reports, a different GBCA (Omniscan, 118; OptiMARK, 15; MultiHance, 6; and macrocyclic agent, 11) showed the closest temporal relationship to onset of NSF-like symptoms.The simulation model demonstrated that patients receiving a GBCA with lower market share and late market introduction are less likely to be observed in an unconfounded setting.
conclusionsYear of market introduction, as well as US market share in 2000 to 2007, greatly influenced the absolute number of NSF reports for each GBCA, their a priori probability to cause NSF, as well as their a priori probability to be associated with unconfounded cases of NSF. Variability in case interpretation and pharmacovigilance approaches also influence the absolute number of unconfounded cases and should therefore not be used for comparative risk assessments. This should be primarily based on objective product parameters such as structure, stability, pharmacokinetics, and dose.
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