title: Monoclonal antibodies and progressive multifocal leukoencephalopathy.
abstract: 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.
authors.affiliation: Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Keene
authors.forename: Carole
authors.initials: C
authors.lastname: Legare
authors.forename: Elaine
authors.initials: E
authors.lastname: Taylor
authors.forename: Jim
authors.initials: J
authors.lastname: Gallivan
authors.forename: Gloria Mah
authors.initials: GM
authors.lastname: Cawthorn
authors.forename: Duc
authors.initials: D
authors.lastname: Vu
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002170:Canada; D016208:Databases, Factual / Q000706:statistics & numerical data; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007577:JC Virus / Q000276:immunology / Q000472:pathogenicity; D007968:Leukoencephalopathy, Progressive Multifocal / Q000188:drug therapy* / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors