ArticleDrug safety2014
Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.
Article in Drug safety, 2014. 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 11 papers.
What it found
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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
11 citing papers in PubMed, 31 citations in OpenAlex.
- Probing the in-depth analysis of Serious Adverse Drug Reactions in a tertiary care hospital of Central India.Exploratory research in clinical and social pharmacy · 2025Article
- Adverse drug reactions reporting: Five years analysis from a teaching hospital.Journal of family medicine and primary care · 2022Article
- Contrast Media Adverse Drug Reactions in Highly Polluted Environment.International journal of environmental research and public health · 2022Article
- Fatal contrast medium-induced adverse response to iohexol in carotid artery angioplasty: A case report.Medicine · 2019Article
- The incidence of skin lesions in contrast media-induced chemical hypersensitivity.Experimental and therapeutic medicine · 2019Article
- Medicine Safety Monitoring in Pediatric Population in India.Indian journal of pediatrics · 2016Article
- An update on the Pharmacovigilance Programme of India.Frontiers in pharmacology · 2015Article
- An analysis of completeness and quality of adverse drug reaction reports at an adverse drug reaction monitoring centre in Western India.Perspectives in clinical researchArticle
- Pharmacovigilance Programme of India: Recent developments and future perspectives.Indian journal of pharmacologyReview
- Veterinary pharmacovigilance in India: A need of hour.Indian journal of pharmacologyArticle
- Status of documentation grading and completeness score for Indian individual case safety reports.Indian journal of pharmacologyArticle
Corrections and comments
- Erratum issued
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundContrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval.
objectiveOur objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI).
methodsIndividual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome.
resultsOf the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%).
conclusionsMost of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.
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