{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:48:04Z","timestamp":1786978084424,"version":"build-2736575974"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,10,24]],"date-time":"2020-10-24T00:00:00Z","timestamp":1603497600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Magnetic Resonance Imaging"],"published-print":{"date-parts":[[2021,3]]},"abstract":"\n Background<\/jats:title>\n Ferumoxytol has been studied as an alternative to gadolinium\u2010based MRI contrast agents, but regulatory body warnings currently limit its use.<\/jats:p>\n <\/jats:sec>\n \n Purpose<\/jats:title>\n Estimate the adverse event rate in patients undergoing MRI with ferumoxytol as a contrast agent.<\/jats:p>\n <\/jats:sec>\n \n Study Type<\/jats:title>\n Systematic review.<\/jats:p>\n <\/jats:sec>\n \n Population<\/jats:title>\n Thirty\u2010nine studies including 5411 ferumoxytol administrations in 4336 patients.<\/jats:p>\n <\/jats:sec>\n \n Assessment<\/jats:title>\n Multiple databases were searched for studies using ferumoxytol as an off\u2010label MRI contrast agent in any patient population as of April 2020. Studies were eligible for inclusion if they reported the number and severity of adverse events (classified by American College of Radiology [ACR] severity of acute reactions). Risk of bias was assessed using the ROBINS\u2010I tool.<\/jats:p>\n <\/jats:sec>\n \n Statistical Tests<\/jats:title>\n The proportion of administrations with adverse events was calculated using random effects meta\u2010analysis of proportions.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n No deaths related to ferumoxytol administration were reported. Sixteen studies reported immediate adverse events in 3849 patients undergoing 4901 ferumoxytol administrations. Ninety\u2010seven immediate adverse events were reported and the pooled adverse event proportion for immediate adverse events was 0.02 (95% confidence interval [CI] 0.02\u20130.02). Twenty\u2010three studies reported time\u2010unspecified adverse events in 487 patients undergoing 510 ferumoxytol administrations. Five time\u2010unspecified adverse events were reported; the pooled adverse event proportion for time\u2010unspecified adverse events was 0.01 (95% CI 0.00\u20130.04). 88% of adverse events were mild (90\/102), 11% (11\/102) were moderate, and 1% (1\/102) was severe. Sixteen studies were at low risk of bias, 23 studies were at serious risk of bias. Subgroup analysis by patient population revealed no significant variability (adult vs. pediatric). No studies evaluated the use of ferumoxytol as an alternative to patients who had a prior hypersensitivity reaction to gadolinium\u2010based contrast agents (GBCAs).<\/jats:p>\n <\/jats:sec>\n \n Data Conclusion<\/jats:title>\n The overall adverse event rate for off\u2010label ferumoxytol use as an MRI contrast agent is 2%, with rare severe reactions and no deaths. To date, there are no studies evaluating the safety of ferumoxytol as an alternative to GBCAs in patients with a prior hypersensitivity reaction.<\/jats:p>\n <\/jats:sec>\n \n Level of Evidence<\/jats:title>\n 2<\/jats:p>\n <\/jats:sec>\n \n Technical Efficacy Stage<\/jats:title>\n 5<\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/jmri.27405","type":"journal-article","created":{"date-parts":[[2020,10,24]],"date-time":"2020-10-24T04:07:11Z","timestamp":1603512431000},"page":"840-858","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Safety of Off\u2010Label Use of Ferumoxtyol as a Contrast Agent for\n MRI<\/scp>\n : A Systematic Review and Meta\u2010Analysis of Adverse Events"],"prefix":"10.1002","volume":"53","author":[{"given":"Faraz","family":"Ahmad","sequence":"first","affiliation":[{"name":"Faculty of Medicine University of Ottawa Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lee","family":"Treanor","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Ottawa Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8063-289X","authenticated-orcid":false,"given":"Trevor A.","family":"McGrath","sequence":"additional","affiliation":[{"name":"Department of Radiology University of Ottawa Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Walker","sequence":"additional","affiliation":[{"name":"Department of Radiology University of Ottawa Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8404-4075","authenticated-orcid":false,"given":"Matthew D.F.","family":"McInnes","sequence":"additional","affiliation":[{"name":"University of Ottawa Department of Radiology and Epidemiology Ottawa Ontario Canada"},{"name":"Clinical Epidemiology Program Ottawa Hospital Research Institute Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2653-4786","authenticated-orcid":false,"given":"Nicola","family":"Schieda","sequence":"additional","affiliation":[{"name":"University of Ottawa Department of Radiology and Epidemiology Ottawa Ontario Canada"},{"name":"Clinical Epidemiology Program Ottawa Hospital Research Institute Ottawa Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,10,24]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-015-0275-4"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2017174037"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/RMR.0000000000000106"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.crad.2014.01.003"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mri.2020.02.012"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/RLI.0000000000000000"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2015142423"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2019.5284"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/2054358118778573"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.13131669"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2015142690"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2017161595"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1259\/bjr.20170115"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2018181151"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mri.2016.07.016"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.carj.2018.04.002"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.12126"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmri.24691"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.3174\/ajnr.A6152"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2362.2009.02130.x"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.rli.0000184756.66360.d3"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmri.24330"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00261-019-02163-4"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.7150\/thno.40606"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00330-019-06569-y"},{"key":"e_1_2_6_27_1","unstructured":"Health Canada. Feraheme (ferumoxytol) important changes to the delivery and new restrictions on the use due to information on serious allergic reactions for health professionals. Accessed on April 13 2020. Available from:https:\/\/www.healthycanadians.gc.ca\/recall-alert-rappel-avis\/hc-sc\/2014\/42607a-eng.php."},{"key":"e_1_2_6_28_1","unstructured":"US Food and Drug Administration. FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol). Accessed on April 13 2020. Available from:http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm440138.htm."},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/mrm.26151"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2019190477"},{"key":"e_1_2_6_31_1","volume-title":"Cochrane handbook for systematic reviews of interventions","author":"JPT H","year":"2019"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i157"},{"key":"e_1_2_6_33_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i4919"},{"key":"e_1_2_6_34_1","first-page":"366","article-title":"RoB 2: A revised tool for assessing risk of bias in randomised trials","volume":"4898","author":"Sterne JAC","year":"2019","journal-title":"BMJ"},{"key":"e_1_2_6_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2013.06.443"},{"key":"e_1_2_6_36_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1047951118000306"},{"key":"e_1_2_6_37_1","volume-title":"Guidance on gadolinium\u2010based contrast administration in adult patients","author":"The Royal College of Radiologists","year":"2019"},{"key":"e_1_2_6_38_1","doi-asserted-by":"publisher","DOI":"10.1002\/jmri.23879"},{"key":"e_1_2_6_39_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2020200069"},{"key":"e_1_2_6_40_1","first-page":"200073","article-title":"Adverse events to the gadolinium\u2010based contrast agent gadoxetic acid: Systematic review and meta\u2010analysis","author":"Schieda N","year":"2020","journal-title":"Radiology"},{"key":"e_1_2_6_41_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2020192855"},{"key":"e_1_2_6_42_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2020201644"},{"key":"e_1_2_6_43_1","volume-title":"ACR manual on contrast media","author":"American College of Radiology. 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