Assessment of adverse reaction rates during gadoteridol-enhanced MR imaging in 28 078 patients

Radiology

Volumn 259, Issue 1, 2011, Pages 109-116

  Morgan, Desiree E ^a   Spann, J Stephen ^a   Lockhart, Mark E ^a   Winningham, Beth ^a   Bolus, David N ^a  

^a University of Alabama at Birmingham   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GADOTERIDOL;

ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DISEASE SEVERITY; DRUG ERUPTION; DYSPNEA; ERYTHEMA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; OBSERVATIONAL STUDY; PARESTHESIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; SEIZURE; SIDE EFFECT; SNEEZING; TERTIARY HEALTH CARE; THORAX PAIN; URTICARIA; VOMITING;

ALABAMA; DRUG TOXICITY; FEMALE; HETEROCYCLIC COMPOUNDS; HUMANS; INCIDENCE; MAGNETIC RESONANCE IMAGING; MALE; ORGANOMETALLIC COMPOUNDS; RISK ASSESSMENT; RISK FACTORS;

EID: 79953009747     PISSN: 00338419     EISSN: 15271315     Source Type: Journal    
DOI: 10.1148/radiol.10100906     Document Type: Article

References (24)

1. Kirchin MA, Runge VM. Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging 2003;14(5):426-435. (Pubitemid 37521732)
2. ACR manual on contrast media, version 6, 2008. American College of Radiology. http://www.scribd.com/doc/2952016/Contrast-Media-Administration- Guidelines-by-the-ACR-American-Co0llege-of-Radiology-Version-6-2008. Published 2008. Accessed December 17, 2009.
3. Grobner T. Gadolinium - a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 2006;21(4):1104-1108.
4. ProHance (gadoteridol) injection, 279.3 mg/ml [package insert]. Princeton, NJ: Bracco Diagnostics, 2007.
5. Runge VM, Bradley WG, Brant-Zawadzki MN, et al. Clinical safety and efficacy of gadoteridol: a study in 411 patients with suspected intracranial and spinal disease. Radiology 1991;181(3):701-709.
6. Hieronim DE, Kanal E, Swanson DP. Dosage of gadoteridol and adverse reactions relative to gadopentetate. Am J Health Syst Pharm 1995;52(22):2556- 2559.
7. Runge VM, Parker JR. Worldwide clinical safety assessment of gadoteridol injection: an update. Eur Radiol 1997;7(suppl 5):243-245.
8. Shellock FG, Hahn HP, Mink JH, Itskovich E. Adverse reaction to intravenous gadoteridol. Radiology 1993;189(1):151-152. (Pubitemid 23292939)
9. Simons CW, Benouni S, Gibbon G, Klaustermeyer W. Severe anaphylactoid shock secondary to gadolinium contrast media. Ann Allergy Asthma Immunol 2009;103(4):359-360.
10. Tweedle MF. The ProHance story: the making of a novel MRI contrast agent. Eur Radiol 1997;7(suppl 5):225-230.
11. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004;24(6):743-749. (Pubitemid 38747859)
12. Bleicher AG, Kanal E. Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of 23,553 administrations of gadobenate dimeglumine. AJR Am J Roentgenol 2008;191(6):W307-W311.
13. Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC. 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(6):1533-1538. (Pubitemid 350174833)
14. 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(4):1124-1127.
15. Li A, Wong CS, Wong MK, Lee CM, Au Yeung MC. Acute adverse reactions to magnetic resonance contrast media - gadolinium chelates. Br J Radiol 2006;79(941):368-371. (Pubitemid 43676338)
16. Bluemke DA, Sahani D, Amendola M, et al. Efficacy and safety of MR imaging with liver-specific contrast agent: U.S. multicenter phase III study. Radiology 2005;237(1):89-98. (Pubitemid 41346150)
17. De Ridder F, De Maeseneer M, Stadnik T, Luypaert R, Osteaux M. Severe adverse reactions with contrast agents for magnetic resonance: clinical experience in 30,000 MR examinations. JBR-BTR 2001;84(4):150-152. (Pubitemid 32945886)
18. Oudkerk M, Sijens PE, Van Beek EJR, Kuijpers TJA. Safety and efficacy of dotarem (Gd-DOTA) versus magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system. Invest Radiol 1995;30(2):75-78.
19. Murphy KJ, Brunberg JA, Cohan RH. Adverse reactions to gadolinium contrast media: a review of 36 cases. AJR Am J Roentgenol 1996;167(4):847-849. (Pubitemid 26322229)
20. Optimark (gadoversetamide injection) 0.5 mmol/mL [package insert]. St Louis, Mo: Mallinckrodt Institute, 1998.
21. Omniscan (gadodiamide injection), sterile aqueous injection, 287 mg/ml [package insert]. Princeton, NJ: GE Healthcare, 2005.
22. Shellock FG, Parker JR, Venetianer C, Pirovano G, Spinazzi A. Safety of gadobenate dimeglumine (MultiHance): summary of findings from clinical studies and postmarketing surveillance. Invest Radiol 2006;41(6):500-509. (Pubitemid 44284184)
23. Penfield JG, Reilly RF. Nephrogenic systemic fibrosis risk: is there a difference between gadolinium-based contrast agents? Semin Dial 2008;21(2):129-134.
24. Reilly RF. Risk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis. Clin J Am Soc Nephrol 2008;3(3):747-751.