Document Detail

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.
MedLine Citation:
PMID:  23448215     Owner:  NLM     Status:  In-Data-Review    
When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.
Ellen Lu; Bing Wei Wang; Colleen Guimond; Anne Synnes; A Dessa Sadovnick; Leanne Dahlgren; Anthony Traboulsee; Helen Tremlett
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Expert review of neurotherapeutics     Volume:  13     ISSN:  1744-8360     ISO Abbreviation:  Expert Rev Neurother     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101129944     Medline TA:  Expert Rev Neurother     Country:  England    
Other Details:
Languages:  eng     Pagination:  251-61     Citation Subset:  IM    
Department of Medicine (Division of Neurology), Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
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