Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe...

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Published in:Clinical pharmacology and therapeutics 2015-11, Vol.98 (5), p.502-505
Main Authors: Segec, A, Keller-Stanislawski, B, Vermeer, NS, Macchiarulo, C, Straus, SM, Hidalgo-Simon, A, De Bruin, ML
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal, Humanized - adverse effects
Decision Making
Disease Management
Drug-Related Side Effects and Adverse Reactions - diagnosis
Drug-Related Side Effects and Adverse Reactions - therapy
Humans
Leukoencephalopathy, Progressive Multifocal - chemically induced
Leukoencephalopathy, Progressive Multifocal - diagnosis
Leukoencephalopathy, Progressive Multifocal - therapy
Risk Assessment - methods
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container_title Clinical pharmacology and therapeutics
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creator Segec, A
Keller-Stanislawski, B
Vermeer, NS
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Straus, SM
Hidalgo-Simon, A
De Bruin, ML
description Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization.
doi_str_mv 10.1002/cpt.199
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subjects Antibodies, Monoclonal, Humanized - adverse effects
Decision Making
Disease Management
Drug-Related Side Effects and Adverse Reactions - diagnosis
Drug-Related Side Effects and Adverse Reactions - therapy
Humans
Leukoencephalopathy, Progressive Multifocal - chemically induced
Leukoencephalopathy, Progressive Multifocal - diagnosis
Leukoencephalopathy, Progressive Multifocal - therapy
Risk Assessment - methods
title Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy
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