Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.
Expert Rev Neurother
; 13(3): 251-60; quiz 261, 2013 Mar.
Article
em En
| MEDLINE
| ID: mdl-23448215
ABSTRACT
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-ß, 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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Complicações na Gravidez
/
Imunossupressores
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Esclerose Múltipla
Tipo de estudo:
Clinical_trials
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Guideline
Limite:
Female
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Humans
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Pregnancy
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article