Authors: Fragoso, Yára D.¹; Finkelsztejn, Alessandro²; Kaimen-Maciel, Damacio R.³; Grzesiuk, Anderson K.⁴; Gallina, Andre S.⁵; Lopes, Josiane³; Morales, Nivea M.O.⁶; Alves-Leon, Soniza V.⁷; de Almeida, Sandra M.G.⁸

Source: CNS Drugs, Volume 24, Number 11, 1 November 2010 , pp. 969-976(8)

Publisher: Adis International

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.

Keywords: Glatiramer-acetate, adverse reactions; Glatiramer-acetate, therapeutic use; Immunomodulators, adverse reactions; Immunomodulators, therapeutic use; Multiple-sclerosis; Pregnancy; Teratogenesis

Document Type: Short communication

Affiliations: 1: 1 Department of Neurology, Universidade Metropolitana de Santos and Departamento Regional de Saúde IV, Santos, Sao Paulo, Brazil 2: 2Department of Neurology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil 3: 3 Department of Neurology, Universidade Estadual de Londrina, Londrina, Parana, Brazil 4: 4 Department of Neurology, Instituto Neurologico e da Coluna Vertebral and Centro de Reabilitacao Integral Dom Aquino Correa, Cuiaba, Mato Gosso, Brazil 5: 5 Piracicaba, Sao Paulo, Brazil 6: 6 Department of Neuropediatrics, Universidade Federal de Uberlândia, Uberlandia, Minas Gerais, Brazil 7: 7 Department of Neurology, Universidade Federal do Rio de Janeiro and Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil 8: 8 Department of Gynecology and Obstetrics, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, Brazil

Publication date: 2010-11-01

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• By this author: Fragoso, Yára D. ;  Finkelsztejn, Alessandro ;  Kaimen-Maciel, Damacio R. ;  Grzesiuk, Anderson K. ;  Gallina, Andre S. ;  Lopes, Josiane ;  Morales, Nivea M.O. ;  Alves-Leon, Soniza V. ;  de Almeida, Sandra M.G.

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