title: Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series.
abstract: 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.
  
  
  METHODS
  Retrospective and multicentre case series.
  
  
  METHODS
  Outpatient services of academic and private institutions caring for patients with MS in Brazil.
  
  
  METHODS
  Eleven women with MS and their children were assessed.
  
  
  METHODS
  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.
  
  
  METHODS
  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.affiliation: Department of Neurology, Universidade Metropolitana de Santos and Departamento Regional de Saúde IV, Santos, Sao Paulo, Brazil. yara@bsnet.com.br
authors.forename: Yára D
authors.initials: YD
authors.lastname: Fragoso
authors.forename: Alessandro
authors.initials: A
authors.lastname: Finkelsztejn
authors.forename: Damacio R
authors.initials: DR
authors.lastname: Kaimen-Maciel
authors.forename: Anderson K
authors.initials: AK
authors.lastname: Grzesiuk
authors.forename: Andre S
authors.initials: AS
authors.lastname: Gallina
authors.forename: Josiane
authors.initials: J
authors.lastname: Lopes
authors.forename: Nivea M O
authors.initials: NM
authors.lastname: Morales
authors.forename: Soniza V
authors.initials: SV
authors.lastname: Alves-Leon
authors.forename: Sandra M G
authors.initials: SM
authors.lastname: de Almeida
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy*; D010455:Peptides / Q000009:adverse effects* / Q000627:therapeutic use*; D011247:Pregnancy; D012189:Retrospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate
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