Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report

British Journal of Radiology

Volumn 87, Issue 1042, 2014, Pages

  Edwards, B J ^a   Laumann, A E ^b   Nardone, B ^b   Miller, F H ^b   Restaino, J ^c   Raisch, D W ^d,e   McKoy, J M ^b   Hammel, J A ^b   Bhatt, K ^b   Bauer, K ^b   Samaras, A T ^b   Fisher, M J ^a   Bull, C ^b   Saddleton, E ^b   Belknap, S M ^b   Thomsen, H S ^f   Kanal, E ^g   Cowper, S E ^h   Abu Alfa, A K ^h,i   West, D P ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c Restaino Law Firm   (United States)

^d University of New Mexico   (United States)

^e UNIVERSITY OF NEW MEXICO   (United States)

^f UNIVERSITY OF COPENHAGEN   (Denmark)

^g UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^h YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ AMERICAN UNIVERSITY OF BEIRUT   (Lebanon)

Author keywords

[No Author keywords available]

Indexed keywords

CONTRAST MEDIUM; GADOBENATE DIMEGLUMINE; GADOBUTROL; GADODIAMIDE; GADOFOSVESET; GADOLINIUM; GADOLINIUM BASED CONTRAST AGENT; GADOLINIUM PENTETATE MEGLUMINE; GADOTERATE MEGLUMINE; GADOTERIC ACID; GADOTERIDOL; GADOVERSETAMIDE; GADOXETIC ACID; IONIC CONTRAST MEDIUM; NONIONIC CONTRAST MEDIUM; UNCLASSIFIED DRUG; GADOBENIC ACID; GADOLINIUM PENTETATE; HETEROCYCLIC COMPOUND; MEGLUMINE; ORGANOMETALLIC COMPOUND;

ARTICLE; BIOPSY; DRUG DATABASE; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HISTOPATHOLOGY; HUMAN; LEGAL DATABASE; METHODOLOGY; NEPHROGENIC SYSTEMIC FIBROSIS; UNSPECIFIED SIDE EFFECT; ADVERSE DRUG REACTION; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; COOPERATION; FACTUAL DATABASE; MALE; REGISTER; UNITED STATES;

CONTRAST MEDIA; COOPERATIVE BEHAVIOR; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GADOLINIUM; GADOLINIUM DTPA; HETEROCYCLIC COMPOUNDS; HUMANS; MALE; MEGLUMINE; NEPHROGENIC FIBROSING DERMOPATHY; ORGANOMETALLIC COMPOUNDS; PHARMACOVIGILANCE; REGISTRIES; UNITED STATES;

EID: 84907487460     PISSN: 00071285     EISSN: 1748880X     Source Type: Journal    
DOI: 10.1259/bjr.20140307     Document Type: Article

References (52)

1. Mackay-Wiggan JM, Cohen DJ, Hardy MA, Knobler EH, Grossman ME. Nephrogenic fibrosing dermopathy (scleromyxedemalike illness of renal disease). J Am Acad Dermatol 2003; 48: 55-60. doi: 10.1067/mjd.2003.78
2. Cowper SE. Nephrogenic fibrosing dermopathy: the first 6 years. Curr Opin Rheumatol 2003; 15: 785-90.
3. Hancox JG, Mengesha YM, Sangueza OP, Yosipovitch G. Nephrogenic fibrosing dermopathy after five days of hemodialysis. J Drugs Dermatol 2003; 2: 550-3.
4. Perazella MA, Ishibe S, Perazella MA, Reilly RF. Nephrogenic fibrosing dermopathy: an unusual skin condition associated with kidney disease. Semin Dial 2003; 16: 276-80.
5. Streams BN, Liu V, Liegeois N, Moschella SM. Clinical and pathologic features of nephrogenic fibrosing dermopathy: a report of two cases. J Am Acad Dermatol 2003; 48: 42-7. doi: 10.1067/mjd.2003.77
6. Edsall LC, English JC 3rd, Teague MW, Patterson JW. Calciphylaxis and metastatic calcification associated with nephrogenic fibrosing dermopathy. J Cutan Pathol 2004; 31: 247-53.
7. Evenepoel P, Zeegers M, Segaert S, Claes K, Kuypers D, Maes B, et al. Nephrogenic fibrosing dermopathy: a novel, disabling disorder in patients with renal failure. Nephrol Dial Transplant 2004; 19: 469-73.
8. Jain SM, Wesson S, Hassanein A, Canova E, Hoy M, Fennell RS, et al. Nephrogenic fibrosing dermopathy in pediatric patients. Pediatr Nephrol 2004; 19: 467-70. doi: 10.1007/s00467-003-1380-1
9. Cowper SE, Boyer PJ. Nephrogenic systemic fibrosis: an update. Curr Rheumatol Rep 2006; 8: 151-7.
10. Introcaso CE, Hivnor C, Cowper S, Werth VP. Nephrogenic fibrosing dermopathy/ nephrogenic systemic fibrosis: a case series of nine patients and review of the literature. Int J Dermatol 2007; 46: 447-52.
11. Moreno-Romero JA, Segura S, Mascaró JM Jr, Cowper SE, Julià M, Poch E, et al.Nephrogenic systemic fibrosis: a case series suggesting gadolinium as a possible aetiological factor. Br J Dermatol 2007; 157: 783-7. doi: 10.1111/j.1365-2133.2007.08067.x
12. Gibson SE, Farver CF, Prayson RA. Multiorgan involvement in nephrogenic fibrosing dermopathy: an autopsy case and review of the literature. Arch Pathol Lab Med 2006; 130: 209-12. doi: 10.1043/1543-2165(2006)130[209:MIINFD]2.0.CO;2
13. Holzem KE, Nardone B, Lomasney JW, Yazdan P, Gerami P, West DP, et al. Superior vena cava obstruction associated with nephrogenic systemic fibrosis. J Drugs Dermatol 2014; 13: 615-18.
14. Levine JM, Taylor RA, Elman LB, Bird SJ, Lavi E, Stolzenberg ED, et al. Involvement of skeletal muscle in dialysis-associated systemic fibrosis (nephrogenic fibrosing dermopathy). Muscle Nerve 2004; 30: 569-77. doi: 10.1002/mus.20153
15. Girardi M, Kay J, Elston DM, Leboit PE, Abu-Alfa A, Cowper SE. Nephrogenic systemic fibrosis: clinicopathological definition and workup recommendations. J Am Acad Dermatol 2011; 65: 1095-1106.e7. doi: 10.1016/j.jaad.2010.08.041
16. Grobner T. Gadolinium - a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 2006; 21: 1104-8. doi: 10.1093/ndt/gfk062
17. Cowper SE, Su LD, Bhawan J, Robin HS, LeBoit PE. Nephrogenic fibrosing dermopathy. Am J Dermatopathol 2001; 23: 383-93.
18. Swaminathan S, High WA, Ranville J, Horn TD, Hiatt K, Thomas M, et al. Cardiac and vascular metal deposition with high mortality in nephrogenic systemic fibrosis. Kidney Int 2008; 73: 1413-18. doi: 10.1038/ki.2008.76
19. Hui FK, Mullins M. Persistence of gadolinium contrast enhancement in CSF: a possible harbinger of gadolinium neurotoxicity? AJNR Am J Neuroradiol 2009; 30: E1. doi: 10.3174/ajnr.A1205
20. Song J, Volkov S, Shea CR, Alegre ML, Salgia R, Gregg K, et al. Nephrogenic systemic fibrosis associated with stromal and vascular calcification, report of two cases. J Cutan Pathol 2009; 36(Suppl. 1): 31-4.
21. Arlt S, Cepek L, Rustenbeck HH, Prange H, Reimers CD. Gadolinium encephalopathy due to accidental intrathecal administration of gadopentetate dimeglumine. J Neurol 2007; 254: 810-12. doi: 10.1007/s00415-006-0439-x
22. FDA. Public Health Advisory Gadoliniumcontaining contrast agents for magnetic resonance imaging (MRI): Omniscan, Opti-MARK, Magnevist, ProHance, and Multi- Hance: FDA; 2006 [updated 2 November 2007; cited 17 April 2013]. Available from: http://www.fda.gov/cder/drug/advisory/gadolinium-agents.htm
23. Abujudeh HH, Kaewlai R, Kagan A, Chibnik LB, Nazarian RM, High WA, et al. Nephrogenic systemic fibrosis after gadopentetate dimeglumine exposure: case series of 36 patients. Radiology 2009; 253: 81-9. doi: 10.1148/radiol.2531082160
24. Bennett CL, Nebeker JR, Lyons EA, Samore MH, Feldman MD, McKoy JM, et al. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA 2005; 293: 2131-40. doi: 10.1001/jama.293.17.2131
25. Rostock Jensen J. Independents lawyer report on Omniscan. Ministry of Health. Copenhagen; 2010 [cited 17 April 2013]. Available from: http://sundhedsstyrelsen.dk/da/nyheder/2010/~/media/27FFA968791249BE8E88776BA2D6F037.ashx
26. Lee C, ed. NSF: the Mayo experience. 2nd Annual Scientific Symposium on nephrogenic systemic fibrosis and MR gadolinium-based contrast agents. New Haven, CT: Yale University; 2008.
27. Listing of cases filed in federal court within the gadolinium-based contrast agents products liability litigation, MDL No. 1909 (E.D. OH). (2011).
28. Cowper S. NSF history and description: the registry and data: major and minor criteria. In: the 4th Annual NSF Conference; 14-15 May 2010; New York, NY: New York Academy of Science; 2010.
29. Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol 2007; 2: 264-7.
30. GE Healthcare Position Paper on NSF; 2008. [Cited 17 April 2013.] Available from: http://s3.amazonaws.com/propublica/assets/omniscan/GEHealthcarePositionPaperonNephrogenicSystemicFibrosis2009.pdf
31. Bayer HealthCare Pharmaceuticals. Magnevist safety information. [Cited 17 April 2013.] Available from: http://bayerimaging.com/products/magnevist/safety-information-nsf.php
32. Marckmann P, Skov L, Rossen K, Dupont A, Damholt MB, Heaf JG, et al. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol 2006; 17: 2359-62.
33. Centers for Disease Control and Prevention (CDC). Nephrogenic fibrosing dermopathy associated with exposure to gadoliniumcontaining contrast agents - St Louis, Missouri, 2002-2006. MMWR Morb Mortal Wkly Rep 2007; 56: 137-41.
34. Othersen JB, Maize JC, Woolson RF, Budisavljevic MN. Nephrogenic systemic fibrosis after exposure to gadolinium in patients with renal failure. Nephrol Dial Transplant 2007; 22: 3179-85. doi: 10.1093/ndt/gfm584
35. Lee CU, Wood CM, Hesley GK, Leung N, Bridges MD, Lund JT, et al. Large sample of nephrogenic systemic fibrosis cases from a single institution. Arch Dermatol 2009; 145: 1095-102. doi: 10.1001/archdermatol.2009.232
36. Janus N, Launay-Vacher V, Karie S, Clement O, Ledneva E, Frances C, et al. Prevalence of nephrogenic systemic fibrosis in renal insufficiency patients: results of the FINEST study. Eur J Radiol 2010; 73: 357-9. doi: 10.1016/j.ejrad.2008.11.021
37. Perez-Rodriguez J, Lai S, Ehst BD, Fine DM, Bluemke DA. Nephrogenic systemic fibrosis: incidence, associations, and effect of risk factor assessment - report of 33 cases. Radiology 2009; 250: 371-7.
38. Collidge TA, Thomson PC, Mark PB, Traynor JP, Jardine AG, Morris ST, et al. Gadoliniumenhanced MR imaging and nephrogenic systemic fibrosis: retrospective study of a renal replacement therapy cohort. Radiology 2007; 245: 168-75. doi: 10.1148/radiol.2451070353
39. Marckmann P, Skov L. Nephrogenic systemic fibrosis: clinical picture and treatment. Radiol Clin North Am 2009; 47: 833-40. doi: 10.1016/j.rcl.2009.05.004
40. FDA. Public health advisory update on magnetic resonance imaging (MRI) contrast agents containing gadolinium and nephrogenic fibrosing dermopathy; 2006 [updated 16 August 2013]. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124344.htm
41. FDA. Information for healthcare professionals: gadolinium-based contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, Opti- MARK, ProHance); 2010 [updated 19 July 2013]. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142884.htm.
42. EMA. European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadoliniumcontaining contrast agents; 2009 [updated 19 July 2013]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl5pages/news-and-events/news/2009/11/news-detail-000408.jsp&mid5WC0b01ac058004d5c1
43. Thomsen HS; European Society of Urogenital Radiology. ESUR guideline: gadoliniumbased contrast media and nephrogenic systemic fibrosis. Eur Radiol 2007; 17: 2692-6.
44. Stenver DI. Pharmacovigilance: what to do if you see an adverse reaction and the consequences. Eur J Radiol 2008; 66: 184-6. doi: 10.1016/j.ejrad.2008.02.009
45. Kanal E, Bell C, Borgstede JP, Bradley WG Jr, Froelich JW, Gilk T, et al; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices. 2007. AJR Am J Roentgenol 2007; 188: 447-74. doi: 10.2214/AJR.06.1616
46. van der Molen AJ. Nephrogenic systemic fibrosis and the role of gadolinium contrast media. J Med Imaging Radiat Oncol 2008; 52: 339-50. doi: 10.1111/j.1440-1673.2008.01965.x
47. Meaney JF, Ridgway JP, Chakraverty S, Robertson I, Kessel D, Radjenovic A, et al. Stepping-table gadolinium-enhanced digital subtraction MR angiography of the aorta and lower extremity arteries: preliminary experience. Radiology 1999; 211: 59-67.
48. Thomsen HS. Nephrogenic systemic fibrosis: history and epidemiology. Radiol Clin North Am 2009; 47: 827-31. doi: 10.1016/j.rcl.2009.05.003
49. Murphy KP, Szopinski KT, Cohan RH, Mermillod B, Ellis JH. Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors. Acad Radiol 1999; 6: 656-64. doi: 10.1016/S1076-6332(99)80114-7
50. Abu-Alfa AK. Nephrogenic systemic fibrosis and gadolinium-based contrast agents. Adv Chronic Kidney Dis 2011; 18: 188-98. doi: 10.1053/j.ackd.2011.03.001
51. Leiner T, Kucarczyk W. Special issue: nephrogenic systemic fibrosis. J Magn Reson Imaging 2009; 30: 1233-5. doi: 10.1002/jmri.21985
52. FDA Center for Drug Evaluation and Research. Joint cardiovascular and renal drugs and drug safety and risk management advisory committees. Gaithersburg, MD: FDA; 2009. pp. 81.