Document Detail


Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series.
MedLine Citation:
PMID:  20806993     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Glatiramer acetate is a US FDA category B drug with regard to use by pregnant women with multiple sclerosis (MS). There are no data currently available for the continuous use of glatiramer acetate during pregnancy.
OBJECTIVE: To assess the risks and benefits of glatiramer acetate used throughout pregnancy among women with active MS.
DESIGN: Retrospective and multicentre case series.
SETTINGS: Outpatient services of academic and private institutions caring for patients with MS in Brazil.
PATIENTS: Eleven women with MS and their children were assessed.
INTERVENTION: Retrospective evaluation of women with MS who received glatiramer acetate continuously for at least 7 months during pregnancy. This evaluation was performed by the neurologist responsible for the patient. Children aged 1 year and over, born to mothers who received glatiramer acetate during pregnancy, were assessed using the Denver II developmental screening test.
MAIN OUTCOME MEASUREMENTS: Obstetric, neonatal and developmental outcomes.
RESULTS: No drug-related obstetric complications were observed. No specific drug-related malformations, neonatal complications or developmental abnormalities were observed in the children. Postnatal MS relapse rates remained significantly lower than antenatal rates in these patients.
CONCLUSIONS: No deleterious effects from glatiramer acetate were observed in these pregnant women with MS or in their offspring. No increment in postnatal relapse rate was observed. However, the use of glatiramer acetate during pregnancy should be restricted to the most difficult cases, in which the benefits clearly outweigh the risks.
Authors:
Yára D Fragoso; Alessandro Finkelsztejn; Damacio R Kaimen-Maciel; Anderson K Grzesiuk; Andre S Gallina; Josiane Lopes; Nivea M O Morales; Soniza V Alves-Leon; Sandra M G de Almeida
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  CNS drugs     Volume:  24     ISSN:  1172-7047     ISO Abbreviation:  CNS Drugs     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-11     Completed Date:  2011-01-26     Revised Date:  2011-12-06    
Medline Journal Info:
Nlm Unique ID:  9431220     Medline TA:  CNS Drugs     Country:  New Zealand    
Other Details:
Languages:  eng     Pagination:  969-76     Citation Subset:  IM    
Affiliation:
Department of Neurology, Universidade Metropolitana de Santos and Departamento Regional de Saúde IV, Santos, Sao Paulo, Brazil. yara@bsnet.com.br
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Female
Humans
Immunosuppressive Agents / adverse effects*,  therapeutic use*
Multiple Sclerosis / drug therapy*
Peptides / adverse effects*,  therapeutic use*
Pregnancy
Retrospective Studies
Risk Assessment
Time Factors
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Peptides; 0/copolymer 1

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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