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1.
Expert Rev Neurother ; 14(2): 127-30, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24417188

RESUMEN

Natalizumab is a potent immunosuppressive monoclonal antibody used for the treatment of multiple sclerosis (MS). While definite guidelines for the safety of natalizumab prescriptions are available in all countries, there are no specific recommendations on how to withdraw the drug if the need arises. There are reports describing MS complications after natalizumab infusions were stopped. Most neurologists seem to stop natalizumab treatment according to their idea on how to best carry out the withdrawal. The present study shows the very different manners in which expert neurologists from 14 MS units in Brazil stopped natalizumab in their patients. The authors concluded that pharmacovigilance on natalizumab must persist after the drug is withdrawn in order to have enough data for adequate recommendations.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Inmunosupresores/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Pautas de la Práctica en Medicina , Humanos , Natalizumab
2.
CNS Drugs ; 27(11): 955-61, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24114585

RESUMEN

INTRODUCTION: Multiple sclerosis (MS) mainly affects women of fertile age. To date, the only recommendation for women with MS intending to become pregnant is to stop all treatment. This recommendation reflects the concerns about the effects of disease-modifying drugs (DMDs) on the offspring. The objective of the present study was to assess the potential long-term effects of maternal exposure to DMDs on the offspring. METHOD: This was a retrospective study revising medical data on the offspring of women with MS. These women now have children aged at least 1 year and include a group of patients that were not exposed to any DMDs for at least 3 months prior to pregnancy and during the whole gestation (control group). Another group of patients had at least 2 weeks of exposure to DMDs, mainly to interferon beta or glatiramer acetate RESULTS: The women with MS participating in this study have children currently aged, on average, 6.6 years (range 1-39 years). There was no pattern of drug-related adverse events or complications in the children whose mothers were exposed to DMDs. No specific long-term adverse events were observed in the offspring of women with MS who were exposed to drugs during pregnancy. The profile of relevant diagnoses in their children was similar to that of children whose mothers had not been exposed to DMDs. CONCLUSIONS: The present retrospective study did not show a specific profile of long-term deleterious drug effects on children born from mothers who were exposed to drugs for MS treatment.


Asunto(s)
Factores Inmunológicos/efectos adversos , Interferón beta/efectos adversos , Esclerosis Múltiple/tratamiento farmacológico , Péptidos/efectos adversos , Complicaciones del Embarazo/tratamiento farmacológico , Efectos Tardíos de la Exposición Prenatal , Adolescente , Adulto , Brasil , Niño , Preescolar , Bases de Datos Factuales , Femenino , Acetato de Glatiramer , Humanos , Factores Inmunológicos/administración & dosificación , Factores Inmunológicos/uso terapéutico , Lactante , Interferón beta/administración & dosificación , Interferón beta/uso terapéutico , Péptidos/administración & dosificación , Péptidos/uso terapéutico , Embarazo , Efectos Tardíos de la Exposición Prenatal/inducido químicamente , Estudios Retrospectivos , Adulto Joven
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