Response to the FDA's May 23, 2007, nephrogenic systemic fibrosis update

Radiology

Volumn 246, Issue 1, 2008, Pages 11-14

  Kanal, Emanuel ^e,f   Broome, Dale R ^a,f   Martin, Diego R ^b,f   Thomsen, Henrik S ^c,d,f  

^a LOMA LINDA UNIVERSITY MEDICAL CENTER   (United States)

^b EMORY UNIVERSITY HOSPITAL   (United States)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d Copenhagen University Hospital ^*  (Denmark)

^e Bracco Research USA   (United States)

^f PRESBYTERIAN UNIVERSITY HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GADOBENATE DIMEGLUMINE; GADODIAMIDE; GADOLINIUM PENTETATE; GADOTERIDOL; GADOVERSETAMIDE; NUCLEAR MAGNETIC RESONANCE IMAGING AGENT;

CONTRAST ENHANCEMENT; DRUG APPROVAL; DRUG MEGADOSE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FIBROSIS; FOOD AND DRUG ADMINISTRATION; HUMAN; KIDNEY FAILURE; NEPHROGENIC SYSTEMIC FIBROSIS; NOTE; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR;

CONTRAST MEDIA; FIBROSIS; GADOLINIUM DTPA; HETEROCYCLIC COMPOUNDS; HUMANS; KIDNEY FAILURE; MAGNETIC RESONANCE IMAGING; MEGLUMINE; ORGANOMETALLIC COMPOUNDS; RISK; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 37349056064     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiol.2461071267     Document Type: Note

References (15)

1. Thomsen HS. Nephrogenic systemic fibrosis: a serious late adverse reaction to gadodiamide. Eur Radiol 2006;16:2619-2621.
2. Thomsen HS, Marckmann P, Logager VB. Enhanced computed tomography or magnetic resonance imaging: a choice between contrast media-induced nephropathy and nephrogenic systemic fibrosis? Acta Radiol 2007;48(6):593-596.
3. Sadowski EA, Bennett LK, Chan MR, et al. Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology 2007;243(1):148-157.
4. Commission on Human Medicines. Nephrogenic systemic fibrosis (NSF) with gadolinium-containing magnetic resonance imaging (MRI) contrast agents: update. Medicines and Healthcare Products Regulatory Agency Web site. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary= true&ssDocName=CON2031543&ssTargetNodeId=221. Published June 26, 2007. Updated July 19, 2007. Accessed July 11, 2007.
5. Sieber M, Pietsch H, Walter J, Weinmann HJ. Are gadolinium contrast agents a possible trigger for the development of nephrogenic fibrosing dermopathy. Presented at the meeting of the European Congress of Radiology, Vienna, Austria, March 9, 2007.
6. Idee JM, Port M, Raynal I, Schaefer M, Le Greneur S, Corot C. Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundam Clin Pharmacol 2006;20:563-576.
7. U.S. Food and Drug Administration. Information for healthcare professionals: gadolinium-Based contrast agents for magnetic resonance imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). Food and Drug Administration Web site. http://www.fda.gov/cder/drug/InfoSheets/HCP/ gcca_200705HCP.pdf. Published June 2006. Updated May 23, 2007. Accessed June 19, 2007.
8. Omniscan [package insert]. Oslo, Norway: GE Healthcare, October 2005.
9. Nephrogenic systemic fibrosis (NSF) and gadolinium-containing MRI contrast agents. Medicines and Healthcare Products Regulatory Agency Web site. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName= CON2030229&ssSourceNodeId=221&ssTargetNodeId=221. Published February 7, 2007. Updated March 2, 2007. Accessed July 11, 2007.
10. U.S. Food and Drug Administration. FDA news: FDA requests boxed warning for contrast agents used to improve MRI images. Food and Drug Administration Web site. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01638.html. Published May 23, 2007. Accessed June 19, 2007.
11. U.S. Food and Drug Administration. Questions and answers on gadolinium-based contrast agents: answer to question 12. Food and Drug Administration Web site. http://www.fda.gov/cder/drug/infopage/gcca/qa_200705. htm. Published May 23, 2007. Accessed June 19, 2007.
12. U.S. Food and Drug Administration. Questions and answers on gadolinium-based contrast agents: answer to question 13. Food and Drug Administration Web site. http://www.fda.gov/cder/drug/infopage/gcca/qa_200705. htm. Published May 23, 2007. Accessed June 19, 2007.
13. Medicines and Healthcare Products Regulatory Agency. Nephrogenic Systemic Fibrosis (NSF) with gadolinium-containing magnetic resonance imaging (MRI) contrast agents: update - increased risk of nephrogenic fibrosing dermopathy/nephrogenic systemic librosis and gadolinium-containing MRI contrast agents: public assessment report. http://www.mhra.gov.uk/home/idcplg?IdcService= SS_GET_PAGE&useSecondary=true&ssDocName=CON2031543&ssTargetNodeld= 221. Published July 26, 2007. Accessed July 29, 2007.
14. MultiHance [package insert]. Princeton, NJ: Bracco Diagnostics, May 2007.
15. Pintaske J, Martirosian P, Graf H, et al. Relaxivity of gadopentetate dimeglumine (Magnevist), gadobutrol (Gadovist), and gadobenate dimeglumine (MultiHance) in human blood plasma at 0.2, 1.5, and 3 tesla. Invest Radiol 2006;41:213-221.