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.
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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