Anaphylaxis associated with gadolinium-based contrast agents: Data from the Food and Drug Administration's adverse event reporting system and review of case reports in the literature

Expert Opinion on Drug Safety

Volumn 13, Issue 1, 2014, Pages 15-23

  Raisch, Dennis W ^a   Garg, Vishvas ^a   Arabyat, Rasha ^a   Shen, Xian ^b   Edwards, Beatrice J ^c   Miller, Frank H ^d   McKoy, June M ^d   Nardone, Beatrice ^d   West, Dennis P ^d  

^a UNIVERSITY OF NEW MEXICO   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

^c Department of General Internal Medicine ^*  (United States)

^d NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Anaphylaxis; FDA adverse event; Gadolinium based contrast agents; Reporting system; Serious adverse event

Indexed keywords

GADOBENATE DIMEGLUMINE; GADOBUTROL; GADODIAMIDE; GADOLINIUM; GADOLINIUM PENTETATE MEGLUMINE; GADOTERATE MEGLUMINE; GADOTERIDOL; GADOVERSETAMIDE; GADOXETIC ACID;

ABDOMINAL PAIN; ANAPHYLACTIC SHOCK; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTICLE; COUGHING; DRUG EFFECT; DRUG SAFETY; DYSPHAGIA; DYSPHONIA; DYSPNEA; DYSRHYTHMIA; FAINTNESS; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HOARSENESS; HUMAN; HYPOTENSION; PRURITUS; RHINORRHEA; STRIDOR; THORAX PAIN; URTICARIA;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; ANAPHYLAXIS; BAYES THEOREM; CONTRAST MEDIA; FEMALE; GADOLINIUM; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84890515686     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2013.832752     Document Type: Article

References (35)

1. Johansson SG, Bieber T, Dahl R, et al. Revised nomenclature for allergy for global use: report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol 2004;113:832-6 (Pubitemid 38608590)
2. Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and management of anaphylaxis: summary report-second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. Ann Emerg Med 2006;47:373-80
3. Tang AW. A practical guide to anaphylaxis. Am Fam Physician 2003;68:1325-32
4. Laroche D, Namour F, Lefrancois C, et al. Anaphylactoid and anaphylactic reactions to iodinated contrast material. Allergy 1999;54(Suppl 58):13-16 (Pubitemid 30126701)
5. Runge VM. Safety of approved MR contrast media for intravenous injection. J Magn Reson Imaging 2000;12:205-13 (Pubitemid 30612863)
6. Bennett CL, Nebeker JR, Lyons EA, et al. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA 2005;293:2131-40 (Pubitemid 40617066)
7. Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf 2003;26:159-86 (Pubitemid 36308102)
8. FDA. Adverse Event Reporting System. 2009. Available from: http://www.fda. gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/ AdverseDrugEffects/default.html [Cited 24 November 2011]
9. FDA. AERS Reporting by Healthcare Providers and Consumers by Year. 2010. Available from: http://www.fda. gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070456.html [Cited 24 November 2011]
10. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001;10:483-6 (Pubitemid 34100774)
11. Falco FJ, Moran JG. Lumbar discography using gadolinium in patients with iodine contrast allergy followed by postdiscography computed tomography scan. Spine (Phila Pa 1976) 2003:28-E1-4
12. Furuichi S, Yasuda S, Arita Y, et al. Gadopentetate dimeglumine as a potential alternative contrast medium during percutaneous coronary intervention: a case report. Circ J 2004;68:972-3 (Pubitemid 39410226)
13. Newport JP, Dusseault BN, Butler C, et al. Gadolinium-enhanced computed tomography cystogram to diagnose bladder augment rupture in patients with iodine sensitivity. Urology 2008;71:984 e9-11
14. Prince MR, Zhang H, Zou Z, et al. Incidence of immediate gadolinium contrast media reactions. AJR Am J Roentgenol 2011;196:W138-43
15. Morcos SK. Review article: acute serious and fatal reactions to contrast media: our current understanding. Br J Radiol 2005;78:686-93 (Pubitemid 41122680)
16. Meth MJ, Maibach HI. Current understanding of contrast media reactions and implications for clinical management. Drug Saf 2006;29:133-41 (Pubitemid 43213887)
17. Jung JW, Kang HR, Kim MH, et al. Immediate hypersensitivity reaction to gadolinium-based MR contrast media. Radiology 2012;264:414-22
18. Murphy KJ, Brunberg JA, Cohan RH. Adverse reactions to gadolinium contrast media: a review of 36 cases. AJR Am J Roentgenol 1996;167:847-9 (Pubitemid 26322229)
19. Abujudeh HH, Kosaraju VK, Kaewlai R. Acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine: experience with 32,659 injections. AJR Am J Roentgenol 2010;194:430-4
20. Knopp MV, Balzer T, Esser M, et al. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol 2006;41:491-9 (Pubitemid 44284183)
21. Kalogeromitros DC, Makris MP, Aggelides XS, et al. Anaphylaxis to gadobenate dimeglumine (Multihance): a case report. Int Arch Allergy Immunol 2007;144:150-4 (Pubitemid 47414330)
22. Jordan RM, Mintz RD. Fatal reaction to gadopentetate dimeglumine. AJR Am J Roentgenol 1995;164:743-4
23. Witte RJ, Anzai LL. Life-Threatening anaphylactoid reaction after intravenous gadoteridol administration in a patient who had previously received gadopentetate dimeglumine. AJNR Am J Neuroradiol 1994;15:523-4 (Pubitemid 24089545)
24. Singer BD, Woodrick RS, Pedicano JB. Severe adverse drug reaction to gadobenate dimeglumine. ScientificWorldJournal 2009;9:363-5
25. Weiss KL. Severe anaphylactoid reaction after i.v. Gd-DTPA. Magn Reson Imaging 1990;8:817-18
26. Galera C, Pur Ozygit L, Cavigioli S, et al. Gadoteridol-induced anaphylaxis - not a class allergy. Allergy 2009;65:132-4
27. Hasdenteufel F, Luyasu S, Renaudin JM, et al. Anaphylactic shock after first exposure to gadoterate meglumine: Two case reports documented by positive allergy assessment. J Allergy Clin Immunol 2008;121:527-8 (Pubitemid 351215162)
28. Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf 2006;29:385-96
29. Moore N, Hall G, Sturkenboom M, et al. Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: The example of sertindole. Pharmacoepidemiol Drug Saf 2003;12:271-81 (Pubitemid 36700601)
30. Salonen OL. Case of anaphylaxis and four cases of allergic reaction following Gd-DTPA administration. J Comput Assist Tomogr 1990;14:912-13 (Pubitemid 20382286)
31. Meuli RA, Maeder P. Life-Threatening anaphylactoid reaction after iv injection of gadoterate meglumine. AJR Am J Roentgenol 1996;166:729
32. Hasdenteufel F, Luyasu S, Renaudin JM, et al. Anaphylactic shock after first exposure to gadoterate meglumine: Two case reports documented by positive allergy assessment. J Allergy Clin Immunol 2008;121:527-8 (Pubitemid 351215162)
33. Hasdenteufel F, Luyasu S, Renaudin JM, et al. Anaphylactic shock after first exposure to a macrocyclic gadolinium chelate: a few comments - Reply. J Allergy Clin Immunol 2008;122:216-17
34. Shepherd M, Lata S, Mani S, et al. Anaphylaxis to gadolinium radiocontrast: a case report and review of the literature. J La State Med Soc 2009;161:282-4
35. Simons CW, Benouni S, Gibbon G, et al. Severe anaphylactoid shock secondary to gadolinium contrast media. Ann Allergy Asthma Immunol 2009;103:359-60