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Drug‐Induced PML: A Global Agenda for a Global Challenge
Author(s) -
Vinhas de Souza M,
KellerStanislawski B,
Blake K,
HidalgoSimon A,
Arlett P,
Dal Pan G
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.4
Subject(s) - clinical pharmacology , drug , medicine , pharmacology , progressive multifocal leukoencephalopathy , drug development , drug reaction , adverse effect , intensive care medicine , immunology , multiple sclerosis
The occurrence of severe adverse events such as progressive multifocal leukoencephalopathy (PML) has the potential to limit the benefits of highly efficacious medicines being developed to fulfill unmet clinical needs across therapeutic areas. Following an Expert meeting in London in July 2011 (http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500111562.pdf), a research agenda, highlighting methodological, clinical, and communication elements, to mitigate the risk and improve the management of drug-induced PML has been agreed upon.