Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance

Bibliography

• Official Journal of Italian Republic no. 142, Ordinary Supplement no. 153 June 21st, 2006. Legislative Decree April 24, 2006, n. 219 “Implementation of directive 2001/83/EC (and subsequent amending directives) relates to the Community code relating to the medicinal products for human use, as well as the directive 2003/94/EC”. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/DL_2006_219_0.pdf [Last accessed 24 November 2014]
   Google Scholar
• Kvedariene V, Martins P, Rouanet L, et al. Diagnosis of iodinated contrast media hypersensitivity: results of a 6-year period. Clin Exp Allergy 2006;36:1072-7
   PubMed Web of Science ®Google Scholar
• Dillman JR, Ellis JH, Cohan RH, et al. Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults. AJR Am J Roentgenol 2007;189:1533-8
   PubMed Web of Science ®Google Scholar
• Brockow K. Contrast media hypersensitivity–scope of the problem. Toxicology 2005;209:189-92
   PubMed Web of Science ®Google Scholar
• Gomez AND Ariza A, Blanca-Lopez N, et al. Nonimmediate hypersensitivity reactions to iodinated contrast media. Curr Opin Allergy Clin Immunol 2013;13:345-53
   PubMed Web of Science ®Google Scholar
• Jung JW, Kang HR, Kim MH, et al. Immediate hypersensitivity reaction to gadolinium-based MR contrast media. Radiology 2012;264:414-22
   PubMed Web of Science ®Google Scholar
• Rossi C, Reginelli A, D’Amora M, et al. Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging. J Biol Regul Homeost Agents 2014;28:155-65
   PubMed Web of Science ®Google Scholar
• Andrew AND Berg KJ. Influx is underway by effects of X-ray contrast media. J Toxicol Clin Toxicol 2004;42:325-32
   PubMedGoogle Scholar
• Namasivayam S, Kalra MK, Torres WE, et al. Adverse reactions to intravenous iodinated contrast media: an update. Curr Probl Diagn Radiol 2006;35:164-9
   PubMedGoogle Scholar
• Morcos SK. Acute serious and fatal reactions to contrast media: our current understanding. Br J Radiol 2005;78:686-93
   PubMed Web of Science ®Google Scholar
• Trcka J, Schmidt C, Seitz CS, et al. Anaphylaxis to iodinated contrast material: nonallergic hypersensitivity or IgE-mediated allergy? AJR Am J Roentgenol 2008;190:666-70
   PubMed Web of Science ®Google Scholar
• Lasser EC. The multipotential pseudoantigenicity of X-ray contrast media. Pseudoantigen excess may downregulate the release of hypotensive mediators. Int Arch Allergy Immunol 2000;123:282-90
   PubMed Web of Science ®Google Scholar
• Lasser EC, Berry CC, Talner LB, et al. Pretreatment with corticosteroids to alleviate reactions to intravenous contrast material. N Engl J Med 1987;317:845-9
   PubMed Web of Science ®Google Scholar
• Namasivayam S, Kalra MK, Torres WE, et al. Adverse reactions to intravenous iodinated contrast media: a primer for radiologists. Emerg Radiol 2006;12:210-15
   PubMedGoogle Scholar
• ACR manual on contrast media. Version 9, Reston, VA: American College of Radiology, ACR Committee on Drugs and Contrast Media. 2013. Available from: http://www.acr.org/∼/media/ACR/Documents/PDF/QualitySafety/Resources/Contrast%20Manual/2013_Contrast_Media.pdf [Last Accessed 11 June 2015]
   Google Scholar
• National Institute of Statistics. Health status of the population and use of health services. Statistic Reports. December 16 pp. 2013. Available from: http://www.istat.it/it/archivio/108565 [Last Accessed 6 May 2015]
   Google Scholar
• Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255-9
   PubMed Web of Science ®Google Scholar
• Spontaneous report databases - European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. 2010. Available from: http://www.encepp.eu/standards_and_guidances/methodologicalGuide3_4.shtml [Last Accessed 6 May 2015]
   Google Scholar
• Directive 2010/84/EU, Article 102e. 2010. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF [Last Accessed 6 May 2015]
   Google Scholar
• Naranjo CA, Bust U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45
   PubMed Web of Science ®Google Scholar
• Böhm I, Heverhagen JT, Klose KJ. Classification of acute and delayed contrast media-induced reactions: proposal of a three-step system. Contrast Media Mol Imaging 2012;7:537-41
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation; E2D: Post-Approval safety data management: Definitions and standards for expedited reporting. 2014. Available from: http://www.emea.eu.int/pdfs/human/ich/394503en.pdf [Last accessed 24 November 2014]
   Google Scholar
• EudraLex. Volume 9. Pharmacovigilance: medicinal products for human use and veterinary products. 2011. Available from: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9_10-2004_en.pdf [Last Accessed 6 May 2015]
   Google Scholar
• ACR Manual on Contrast Media-Version 9, 2013. Published by the American College of Radiology. Available from: http://www.acr.org/quality-safety/resources/contrast-manual [Last accessed 24 November 2014]
   Google Scholar
• Greenberger PA, Patterson R. The prevention of immediate generalized reactions to radiocontrast media in high-risk patients. J Allergy Clin Immunol 1991;87:867-72
   PubMed Web of Science ®Google Scholar
• DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics. c1974-2013. Available from: http://www.micromedexsolutions.com/micromedex2/librarian# [Last accessed 24 November 2014]
   Google Scholar
• Microsoft. Microsoft Excel [windows]. Microsoft; Redmond, Washington: 2013
   Google Scholar
• Meyboom RHB, Egberts ACG, Gribnau FWJ, et al. Pharmacovigilance in perspective. Drug Saf 1999;21:429-47
   PubMed Web of Science ®Google Scholar
• Cutroneo P, Polimeni G, Curcuruto R, et al. Adverse reactions to contrast media: an analysis from spontaneous reporting data. Pharmacol Res 2007;56:35-41
   PubMed Web of Science ®Google Scholar
• Thomsen HS, Dorph S. High-osmolar and low-osmolar contrast media. An update on frequency of adverse drug reactions. Acta Radiol 1993;34:205-9
   PubMed Web of Science ®Google Scholar
• Katayama H, Yamaguchi K, Kozuka T, et al. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology 1990;175:621-8
   PubMed Web of Science ®Google Scholar
• Lasser EC, Lyon SG, Berry CC. Reports on contrast media reactions: analysis of data from reports to the U. S. Food and Drug Administration. Radiology 1997;203:605-10
   PubMed Web of Science ®Google Scholar
• Cochran ST, Bomyea K, Sayre JW. Trends in adverse events after IV administration of contrast media. AJR Am J Roentgenol 2001;176:1385-8
   PubMed Web of Science ®Google Scholar
• Rawlings MD, Thompson JP. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug. reactions. Oxford University Press, Oxford, UK; 1977. 44
   Google Scholar
• Morcos SK, Thomsen HS. Adverse reactions to iodinated contrast media. Eur Radiol 2001;11:1267-75
   PubMed Web of Science ®Google Scholar
• Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol 2009;193:1124-7
   PubMed Web of Science ®Google Scholar
• Nyman U, Elmståhl B, Leander P, et al. Are gadolinium-based contrast media really safer than iodinated media for digital subtraction angiography in patients with azotemia? Radiology 2002;223(2):311-18; discussion 328-9
   PubMed Web of Science ®Google Scholar
• Wysowski DK, Nourjah P. Deaths attributed to X-ray contrast media on U. S. death certificates. AJR Am J Roentgenol 2006;186:613-15
   PubMed Web of Science ®Google Scholar
• Dillman JR, Strouse PJ, Ellis JH, et al. Incidence and severity of acute allergic-like reactions to IV nonionic iodinated contrast material in children. AJR Am J Roentgenol 2007;188:1643-7
   PubMed Web of Science ®Google Scholar
• Callahan MJ, Poznauskis L, Zurakowski D, et al. Nonionic iodinated intravenous contrast material-related reactions: incidence in large urban children’s hospital–retrospective analysis of data in 12,494 patients. Radiology 2009;250:674-81
   PubMed Web of Science ®Google Scholar
• Shehadi WH, Toniolo G. Adverse reactions to contrast media: a report from the Committee on Safety of Contrast Media of the International Society of Radiology. Radiology 1980;137:299-302
   PubMed Web of Science ®Google Scholar
• Ansell G, Tweedie MC, West CR, et al. The current status of reactions to intravenous contrast media. Invest Radiol 1980;15:S32-9
   PubMed Web of Science ®Google Scholar
• Lang DM, Alpern MB, Visintainer PF, et al. Increased risk for anaphylactoid reaction from contrast media in patients on beta-adrenergic blockers or with asthma. Ann Intern Med 1991;115:270-6
   PubMed Web of Science ®Google Scholar
• Greenberger PA, Meyers SN, Kramer BL, et al. Effects of beta-adrenergic and calcium factor on the development of anaphylactoid reactions from radiographic mode contrast media during cardiac angiography. J Allergy Clin Immunol 1987;80:698-702
   PubMed Web of Science ®Google Scholar
• Kalyesubula R, Bagasha P, Perazella BUT. ACE-I/ARB therapy prior to contrast exposure: what should the clinician do? Biomed Res Int 2014;1:1-7
   Web of Science ®Google Scholar
• Lasser EC, Berry CC, Mishkin MM, et al. Pretreatment with corticosteroids to prevent adverse reactions to nonionic contrast media. AJR Am J Roentgenol 1994;162:523-6
   PubMed Web of Science ®Google Scholar
• Davies P, Roberts MB, Roylance J. Acute reactions to urographic contrast media. Br Med J 1975;2:434-7
   PubMed Web of Science ®Google Scholar
• Jingu A, Fukuda J, Taketomi-Takahashi A, et al. Breakthrough reactions of iodinated and gadolinium contrast media after oral steroid premedication protocol. BMC Med Imaging 2014;14:34
   PubMed Web of Science ®Google Scholar
• Schopp Career History JG, Iyer RS, Wang CL, et al. Allergic reactions to iodinated contrast media: premedication considerations for patients at risk. Emerg Radiol 2013;20:299-306
   PubMedGoogle Scholar
• Tramer MR, Von elm E, Loubeyre P. Pharmacological prevention of serious anaphylactic reactions due to iodinated contrast media: systematic review. BMJ 2006;333:675
   PubMed Web of Science ®Google Scholar
• Brockow K, Christiansen C, Kanny G, et al. Management of hypersensitivity reactions to iodinated contrast media. Allergy 2005;60:150-8
   PubMed Web of Science ®Google Scholar
• Parretta E, Ianniello B, Ferrazin F, et al. Italian post-marketing surveillance for adverse event reports after MF59 adjuvanted H1N1v vaccination. Vaccine 2011;29:3708-13
   PubMed Web of Science ®Google Scholar
• Capuano A, Irpino A, Gallo M, et al. Regional surveillance of emergency department visits for outpatient adverse drug events. Eur J Clin Pharmacol 2009;65:721-8
   PubMed Web of Science ®Google Scholar
• Capuano A, Motola G, Russo F, et al. Adverse drug events in two emergency departments in Naples, Italy: an observational study. Pharmacol Res 2004;50:631-6
   PubMed Web of Science ®Google Scholar