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Monoclonal Antibodies and Progressive Multifocal Leukoencephalopathy

Published online by Cambridge University Press:  02 December 2014

Daniel L. Keene ,
Carole Legare ,
Elaine Taylor ,
Jim Gallivan ,
Gloria Mah Cawthorn  and
Duc Vu
Daniel L. Keene*
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
Carole Legare
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
Elaine Taylor
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
Jim Gallivan
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
Gloria Mah Cawthorn
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
Duc Vu
Affiliation:
Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada
*
Marketed Biologicals, Biotechnology and Natural Health Products Bureau, 200 Tunney's Pasture Driveway, Ottawa, Ontario, K1A 0K9, Canada
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Abstract

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Monoclonal antibodies have become an important treatment option for a number of serious conditions. Concerns have arisen about the potential association of these products with progressive multifocal leukoencephalopathy (PML). A list of monoclonal antibodies authorized for sale was derived from the Health Canada Drug Product Database. Case reports of PML after exposure to a monoclonal antibody authorized for use in Canada were retrieved by searching Canada Vigilance and WHO adverse event databases and through a Pub MED/Medline literature search. 182 adverse event case reports were retrieved (adalimumab -1 case, alemtuzumab-14, bevacizumab -3, cetuximab -1, efalizumab - 8, ibritumomab tiuxetan-5, infliximab-4, natalizumab-32, and rituximab-114). The Canadian Product Monographs for natalizumab and ritiximab contain box warnings for PML. A natalizumab registry has been established.

Type
Review Article
Information
Canadian Journal of Neurological Sciences , Volume 38 , Issue 4 , July 2011 , pp. 565 - 571
Copyright
Copyright © The Canadian Journal of Neurological 2011

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