Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project

McKoy, June M.; Fisher, M.; Courtney, D. Mark; Raisch, Dennis W.; Edwards, Beatrice J.; Scheetz, Marc H.; Belknap, Steven M.; Trifilio, Steven; Samaras, Athena T.; Liebling, Dustin B.; Nardone, Beatrice; Tulas, Katrina M.; West, Dennis P.

doi:10.1007/s40264-013-0042-x

Cited by 15 publications

(10 citation statements)

References 40 publications

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“…Other parameters such as concomitant radiotherapy and SJS/TEN outcomes were noted when available. In addition, as part of the RADAR (Research on Adverse Drug events And Reports) project [15], the FAERS database was searched for reports of SJS and TEN in association with anticancer agents as suspect drugs from 1968 through August 2012 (the most recent date for available FAERS data release) [16]. …”

Section: Methodsmentioning

confidence: 99%

Life-threatening dermatologic adverse events in oncology

et al. 2014

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Background: The incidence of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. Methods: We searched the literature (Ovid:1950-June 2013 and PubMed:1948-June 2013) using terms for SJS/TEN and anticancer therapy. Primary case reports, case series, and clinical trials were included. Additionally, MedWatch, Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968-August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3) and empirical Bayes geometric mean (EBGM>2, N>3, lower 95% confidence interval (EBGM0.05 >2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. Results: There were 45 SJS and 37 TEN cases associated with 17 and 22 anticancer drugs in the literature, respectively. Among cases in FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine . Conclusion: Several drugs reported in published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to assist oncology practitioners in the recognition of possible, yet uncommon, serious and/or life-threatening skin reactions.

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Section: Methodsmentioning

confidence: 99%

Life-threatening dermatologic adverse events in oncology

et al. 2014

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“…Using RADAR (Research on Adverse Drug events and Reports) methodology, we searched a large urban academic centre EMR database and calculated the relative risk (RR) of melanoma in subjects exposed to TNFαIs compared with nonexposed subjects. Again using RADAR methodology, we searched the FAERS database for terms related to melanoma, including malignant melanoma, malignant melanocytic tumour, melanoma in situ , amelanotic melanoma, metastatic melanoma, lentigo maligna, Hutchinson melanocytic freckle, uveal melanoma and others, combined with all five currently FDA‐approved TNFαIs, namely infliximab, golimumab, etanercept, adalimumab and certolizumab pegol.…”

Section: Methodsmentioning

confidence: 99%

Melanoma associated with tumour necrosis factor-α inhibitors: a Research on Adverse Drug events And Reports (RADAR) project

et al. 2014

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Background Tumor necrosis factor-alpha inhibitors (TNFαIs) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNFαIs the Food and Drug Administration (FDA) label states, “melanoma has been reported in patients treated with these agents.” Objectives Determine whether a statistically-significant association exists between administration of TNFαIs and development of malignant melanoma. Methods We searched the FDA Adverse Events Reporting System (FAERS) database for terms related to melanoma and TNFαIs for detection of safety signals. We also searched a large urban academic electronic medical record (EMR) database for which we calculated the relative risk (RR) of melanoma in subjects exposed to TNFαIs vs. non-exposed subjects. Results There were 972 reports of melanoma associated with a TNFαIs identified in the FAERS database, with 69 reports among individuals using more than one TNFαI. A safety signal was detected for infliximab (I) golimumab (G), etanercept (E), and adalimumab (A). Cetrolizumab pegol (CP) had no detectible safety signal. For TNFαIs as a class of drugs, a safety signal was detectable in the FAERS database, and RR was significant in the EMR database. For the EMR cohort, 6,045 patients were exposed to TNFαIs and 35 cases of melanoma were detected. Significance for RR was detected for A (RR = 1.8, p = 0.02) and E (RR 2.35, p = 0.0004). Conclusions We identified a significant association between exposure to TNFαIs and malignant melanoma in two different analyses. Our findings add to existing evidence linking these agents with the occurrence of malignant melanoma. Additional investigations are required to further explore this association and the risk of melanoma with TNFαI therapy.

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“…The program systematically investigates and disseminates information describing serious and previously unrecognized adverse drug and device reactions; over 40 such reports have been generated since 1998. The overarching goals of the program are to identify, evaluate and disseminate reports on adverse drug and device reactions, thus improving patient safety [24]. …”

Section: Methodsmentioning

confidence: 99%

“…After Northwestern University Institutional Review Board (IRB) approval, using RADAR (Research on Adverse Drug events And Reports) methodology [24, 25], we examined several data sources, including the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the International Center for NSF Research (ICNSFR) registry and published case reports. Pediatric patients are defined as 18 years and younger.…”

Section: Methodsmentioning

confidence: 99%

Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report

et al. 2013

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Background Nephrogenic systemic fibrosis is a fibrosing disorder associated with exposure to gadolinium-based contrast agents in people with severely compromised renal function. Objective The purpose of this study was to determine the reported number of cases of nephrogenic systemic fibrosis in children using three distinct publicly available data sources. Materials and methods We conducted systematic searches of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the International Center for Nephrogenic Systemic Fibrosis Research (ICNSFR) registry and published literature from January 1997 through September 2012. We contacted authors of individual published cases to obtain follow-up data. Data sets were cross-referenced to eliminate duplicate reporting. Results We identified 23 children with nephrogenic systemic fibrosis. Seventeen had documented exposure to gadolinium-based contrast agents. Six children had been reported in both the FAERS and the literature, four in the FAERS and the ICNSFR registry and five in all three data sources. Conclusion Nephrogenic systemic fibrosis has been rarely reported in children. Although rules related to confidentiality limit the ability to reconcile reports, active pharmaco-vigilance using RADAR (Research on Adverse Drug events And Reports) methodology helped in establishing the number of individual pediatric cases within the three major data sources.

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Results from the First Decade of Research Conducted by the Research on Adverse Drug Events and Reports (RADAR) Project

Cited by 15 publications

References 40 publications

Life-threatening dermatologic adverse events in oncology

Life-threatening dermatologic adverse events in oncology

Melanoma associated with tumour necrosis factor-α inhibitors: a Research on Adverse Drug events And Reports (RADAR) project

Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report

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