アブストラクト | 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. |
ジャーナル名 | The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques |
投稿日 | 2011/6/16 |
投稿者 | Keene, Daniel L; Legare, Carole; Taylor, Elaine; Gallivan, Jim; Cawthorn, Gloria Mah; Vu, Duc |
組織名 | Biotechnology and Natural Health Products Bureau, Ottawa, Ontario, Canada. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/21672696/ |