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Article

Pharmacovigilance and PML in the oncology setting

Charles L. Bennett, MD, PhD, MPP
Cleveland Clinic Journal of Medicine November 2011, 78 (11 suppl 2) S13-S17; DOI: https://doi.org/10.3949/ccjm.78.s2.04
Charles L. Bennett
Endowed Chair, Center of Economic Excellence for Medication Safety and Efficacy; Josie M. Fletcher Professor of Pharmacy; South Carolina College of Pharmacy, Hollings Cancer Center, and Arnold School of Public Health; University of South Carolina and Medical University of South Carolina, Columbia and Charleston, SC
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ABSTRACT

Methods developed by the Southern Network on Adverse Reactions project, the only state-funded pharmacovigilance program in the nation, are invaluable in identifying rare and serious drug events and in disseminating related safety reports quickly throughout the medical community. An important discovery was identification and reporting of an association of rituximab and progressive multifocal leukoencephalopathy (PML) in patients without human immunodeficiency virus (HIV). A recent investigation identified 57 patients with rituximab-associated PML, including bone marrow samples, brain biopsies, and autopsy materials from patients with lymphoma and PML who tested positive for JC virus. The investigation identified an association of rituximab-chemotherapy administration and PML, although a causal relationship remains an area of active investigation. Additional investigations evaluated the epidemiology of PML in the oncology setting before and after the introduction of rituximab for lymphoma treatment. Focused analyses investigated risk factors for development of this rare complication. Further studies are needed to investigate the pathophysiology, epidemiology, and risk factors for PML developing among HIV-negative cancer patients who receive rituximab and chemotherapy.

Footnotes

  • Dr. Bennett reported that he has no financial relationships that pose a potential conflict of interest with this article.

  • © 2011 The Cleveland Clinic Foundation. All Rights Reserved.
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Cleveland Clinic Journal of Medicine: 78 (11 suppl 2)
Cleveland Clinic Journal of Medicine
Vol. 78, Issue 11 suppl 2
1 Nov 2011
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Pharmacovigilance and PML in the oncology setting
Charles L. Bennett
Cleveland Clinic Journal of Medicine Nov 2011, 78 (11 suppl 2) S13-S17; DOI: 10.3949/ccjm.78.s2.04

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Pharmacovigilance and PML in the oncology setting
Charles L. Bennett
Cleveland Clinic Journal of Medicine Nov 2011, 78 (11 suppl 2) S13-S17; DOI: 10.3949/ccjm.78.s2.04
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