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*

*Corresponding author for this work

Research output: Contribution to journalArticle

18 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 languageEnglish (US)
Article number20140307
JournalBritish Journal of Radiology
Volume87
Issue number1042
DOIs
StatePublished - Oct 1 2014

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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    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), [20140307]. https://doi.org/10.1259/bjr.20140307