Faraz Ahmad1, Lee Treanor1, Trevor A McGrath2, Daniel Walker2, Matthew D F McInnes3,4, Nicola Schieda3,4. 1. Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada. 2. Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada. 3. University of Ottawa, Department of Radiology and Epidemiology, Ottawa, Ontario, Canada. 4. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Abstract
BACKGROUND: Ferumoxytol has been studied as an alternative to gadolinium-based MRI contrast agents, but regulatory body warnings currently limit its use. PURPOSE: Estimate the adverse event rate in patients undergoing MRI with ferumoxytol as a contrast agent. STUDY TYPE: Systematic review. POPULATION: Thirty-nine studies including 5411 ferumoxytol administrations in 4336 patients. ASSESSMENT: Multiple databases were searched for studies using ferumoxytol as an off-label 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-I tool. STATISTICAL TESTS: The proportion of administrations with adverse events was calculated using random effects meta-analysis of proportions. RESULTS: No deaths related to ferumoxytol administration were reported. Sixteen studies reported immediate adverse events in 3849 patients undergoing 4901 ferumoxytol administrations. Ninety-seven immediate adverse events were reported and the pooled adverse event proportion for immediate adverse events was 0.02 (95% confidence interval [CI] 0.02-0.02). Twenty-three studies reported time-unspecified adverse events in 487 patients undergoing 510 ferumoxytol administrations. Five time-unspecified adverse events were reported; the pooled adverse event proportion for time-unspecified adverse events was 0.01 (95% CI 0.00-0.04). 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-based contrast agents (GBCAs). DATA CONCLUSION: The overall adverse event rate for off-label 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. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY STAGE: 5.
BACKGROUND:Ferumoxytol has been studied as an alternative to gadolinium-based MRI contrast agents, but regulatory body warnings currently limit its use. PURPOSE: Estimate the adverse event rate in patients undergoing MRI with ferumoxytol as a contrast agent. STUDY TYPE: Systematic review. POPULATION: Thirty-nine studies including 5411 ferumoxytol administrations in 4336 patients. ASSESSMENT: Multiple databases were searched for studies using ferumoxytol as an off-label 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-I tool. STATISTICAL TESTS: The proportion of administrations with adverse events was calculated using random effects meta-analysis of proportions. RESULTS: No deaths related to ferumoxytol administration were reported. Sixteen studies reported immediate adverse events in 3849 patients undergoing 4901 ferumoxytol administrations. Ninety-seven immediate adverse events were reported and the pooled adverse event proportion for immediate adverse events was 0.02 (95% confidence interval [CI] 0.02-0.02). Twenty-three studies reported time-unspecified adverse events in 487 patients undergoing 510 ferumoxytol administrations. Five time-unspecified adverse events were reported; the pooled adverse event proportion for time-unspecified adverse events was 0.01 (95% CI 0.00-0.04). 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-based contrast agents (GBCAs). DATA CONCLUSION: The overall adverse event rate for off-label 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. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY STAGE: 5.
Authors: Sophie C Queler; Ek Tsoon Tan; Christian Geannette; Martin Prince; Darryl B Sneag Journal: Skeletal Radiol Date: 2021-05-07 Impact factor: 2.199
Authors: Karen I Ramirez-Suarez; Luis Octavio Tierradentro-García; Hansel J Otero; Jordan B Rapp; Ammie M White; Sara L Partington; Matthew A Harris; Seth A Vatsky; Kevin K Whitehead; Mark A Fogel; David M Biko Journal: Pediatr Radiol Date: 2021-10-17
Authors: Christopher S Lim; Jorge Abreu-Gomez; Rebecca Thornhill; Nick James; Ahmed Al Kindi; Andrew S Lim; Nicola Schieda Journal: Abdom Radiol (NY) Date: 2021-08-31
Authors: Puja Shahrouki; Kim-Lien Nguyen; John M Moriarty; Adam N Plotnik; Takegawa Yoshida; J Paul Finn Journal: Br J Radiol Date: 2021-09-01 Impact factor: 3.629