title: Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.
abstract: BACKGROUND
  Contrast 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.
  
  
  OBJECTIVE
  Our 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).
  
  
  METHODS
  Individual 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.
  
  
  RESULTS
  Of 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%).
  
  
  CONCLUSIONS
  Most 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.
authors.affiliation: Indian Pharmacopoeia Commission, Raj Nagar Sector-23, Ghaziabad, 201002, UP, India, vivekarts@rediffmail.com.
authors.forename: Vivekanandan
authors.initials: V
authors.lastname: Kalaiselvan
authors.forename: Surbhi
authors.initials: S
authors.lastname: Sharma
authors.forename: Gyanendra Nath
authors.initials: GN
authors.lastname: Singh
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D016208:Databases, Factual; D003973:Diatrizoate / Q000009:adverse effects; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D007472:Iohexol / Q000009:adverse effects; D007479:Iopamidol / Q000009:adverse effects / Q000031:analogs & derivatives; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance
chemical_list: D003287:Contrast Media; D003973:Diatrizoate; C057937:iomeprol; D007472:Iohexol; D007479:Iopamidol
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