CNS Drugs

, Volume 24, Issue 11, pp 969–976 | Cite as

Long-Term Use of Glatiramer Acetate by 11 Pregnant Women with Multiple Sclerosis

A Retrospective, Multicentre Case Series
  • 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
Short Communication

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.

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.

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Copyright information

© Adis Data Information BV 2010

Authors and Affiliations

  • Yára D. Fragoso
    • 1
  • Alessandro Finkelsztejn
    • 2
  • Damacio R. Kaimen-Maciel
    • 3
  • Anderson K. Grzesiuk
    • 4
  • Andre S. Gallina
    • 5
  • Josiane Lopes
    • 3
  • Nivea M. O. Morales
    • 6
  • Soniza V. Alves-Leon
    • 7
  • Sandra M. G. de Almeida
    • 8
  1. 1.Department of NeurologyUniversidade Metropolitana de Santos and Departamento Regional de Saúde IVSantosBrazil
  2. 2.Department of NeurologyHospital de Clínicas de Porto AlegrePorto AlegreBrazil
  3. 3.Department of NeurologyUniversidade Estadual de LondrinaLondrinaBrazil
  4. 4.Department of NeurologyInstituto Neurologico e da Coluna Vertebral and Centro de Reabilitacao Integral Dom Aquino CorreaCuiabaBrazil
  5. 5.PiracicabaBrazil
  6. 6.Department of NeuropediatricsUniversidade Federal de UberlândiaUberlandiaBrazil
  7. 7.Department of NeurologyUniversidade Federal do Rio de Janeiro and Hospital Universitário Clementino Fraga FilhoRio de JaneiroBrazil
  8. 8.Department of Gynecology and ObstetricsUniversidade Federal do Estado do Rio de JaneiroRio de JaneiroBrazil
  9. 9.Department of NeurologyMedical School, UNIMESSantosBrazil

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