Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report

B. J. Edwards; A. E. Laumann; B. Nardone; F. H. Miller; J. Restaino; D. W. Raisch; J. M. McKoy; J. A. Hammel; K. Bhatt; K. Bauer; A. T. Samaras; M. J. Fisher; C. Bull; E. Saddleton; S. M. Belknap; H. S. Thomsen; E. Kanal; S. E. Cowper; A. K. Abu Alfa; D. P. West

doi:10.1259/bjr.20140307

Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report

B. J. Edwards, A. E. Laumann, B. Nardone, F. H. Miller, J. Restaino, D. W. Raisch, J. M. McKoy, J. A. Hammel, K. Bhatt, K. Bauer, A. T. Samaras, M. J. Fisher, C. Bull, E. Saddleton, S. M. Belknap, H. S. Thomsen, E. Kanal, S. E. Cowper, A. K. Abu Alfa, D. P. West

General Internal Medicine

Research output: Contribution to journal › Article › peer-review

30 Scopus citations

Abstract

Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.

Methods: The Research on Adverse Drug events And Reports methodology was used for assessment - the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.

Results: The FAERS encompassed the largest number (n=1395) of NSF reports. The ICNSFR contained the most complete (n=335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.

Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.

Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

Original language	English (US)
Article number	20140307
Journal	British Journal of Radiology
Volume	87
Issue number	1042
DOIs	https://doi.org/10.1259/bjr.20140307
State	Published - Oct 1 2014

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

Access to Document

10.1259/bjr.20140307

Fingerprint

Dive into the research topics of 'Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report'. Together they form a unique fingerprint.

Cite this

Edwards, B. J., Laumann, A. E., Nardone, B., Miller, F. H., Restaino, J., Raisch, D. W., McKoy, J. M., Hammel, J. A., Bhatt, K., Bauer, K., Samaras, A. T., Fisher, M. J., Bull, C., Saddleton, E., Belknap, S. M., Thomsen, H. S., Kanal, E., Cowper, S. E., Abu Alfa, A. K., & West, D. P. (2014). Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report. British Journal of Radiology, 87(1042), Article 20140307. https://doi.org/10.1259/bjr.20140307

Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report. / Edwards, B. J.; Laumann, A. E.; Nardone, B. et al.
In: British Journal of Radiology, Vol. 87, No. 1042, 20140307, 01.10.2014.

Research output: Contribution to journal › Article › peer-review

Edwards, BJ, Laumann, AE, Nardone, B, Miller, FH, Restaino, J, Raisch, DW, McKoy, JM, Hammel, JA, Bhatt, K, Bauer, K, Samaras, AT, Fisher, MJ, Bull, C, Saddleton, E, Belknap, SM, Thomsen, HS, Kanal, E, Cowper, SE, Abu Alfa, AK & West, DP 2014, 'Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report', British Journal of Radiology, vol. 87, no. 1042, 20140307. https://doi.org/10.1259/bjr.20140307

@article{f04a0b504b8a487faa4f1f043640b92c,

title = "Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report",

abstract = "Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.Methods: The Research on Adverse Drug events And Reports methodology was used for assessment - the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.Results: The FAERS encompassed the largest number (n=1395) of NSF reports. The ICNSFR contained the most complete (n=335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.",

author = "Edwards, {B. J.} and Laumann, {A. E.} and B. Nardone and Miller, {F. H.} and J. Restaino and Raisch, {D. W.} and McKoy, {J. M.} and Hammel, {J. A.} and K. Bhatt and K. Bauer and Samaras, {A. T.} and Fisher, {M. J.} and C. Bull and E. Saddleton and Belknap, {S. M.} and Thomsen, {H. S.} and E. Kanal and Cowper, {S. E.} and {Abu Alfa}, {A. K.} and West, {D. P.}",

note = "Publisher Copyright: {\textcopyright} 2014 The Authors.",

year = "2014",

month = oct,

day = "1",

doi = "10.1259/bjr.20140307",

language = "English (US)",

volume = "87",

journal = "British Journal of Radiology",

issn = "0007-1285",

publisher = "British Institute of Radiology",

number = "1042",

}

TY - JOUR

T1 - Advancing pharmacovigilance through academic-legal collaboration

T2 - The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report

AU - Edwards, B. J.

AU - Laumann, A. E.

AU - Nardone, B.

AU - Miller, F. H.

AU - Restaino, J.

AU - Raisch, D. W.

AU - McKoy, J. M.

AU - Hammel, J. A.

AU - Bhatt, K.

AU - Bauer, K.

AU - Samaras, A. T.

AU - Fisher, M. J.

AU - Bull, C.

AU - Saddleton, E.

AU - Belknap, S. M.

AU - Thomsen, H. S.

AU - Kanal, E.

AU - Cowper, S. E.

AU - Abu Alfa, A. K.

AU - West, D. P.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.Methods: The Research on Adverse Drug events And Reports methodology was used for assessment - the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.Results: The FAERS encompassed the largest number (n=1395) of NSF reports. The ICNSFR contained the most complete (n=335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

AB - Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.Methods: The Research on Adverse Drug events And Reports methodology was used for assessment - the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.Results: The FAERS encompassed the largest number (n=1395) of NSF reports. The ICNSFR contained the most complete (n=335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

UR - http://www.scopus.com/inward/record.url?scp=84907487460&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907487460&partnerID=8YFLogxK

U2 - 10.1259/bjr.20140307

DO - 10.1259/bjr.20140307

M3 - Article

C2 - 25230161

AN - SCOPUS:84907487460

SN - 0007-1285

VL - 87

JO - British Journal of Radiology

JF - British Journal of Radiology

IS - 1042

M1 - 20140307

ER -

Advancing pharmacovigilance through academic-legal collaboration: The case of gadolinium-based contrast agents and nephrogenic systemic fibrosis - A research on adverse drug events and reports (RADAR) report

Abstract

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this