Abstract
Introduction
Multiple sclerosis (MS) mainly affects women of fertile age. To date, the only recommendation for women with MS intending to become pregnant is to stop all treatment. This recommendation reflects the concerns about the effects of disease-modifying drugs (DMDs) on the offspring. The objective of the present study was to assess the potential long-term effects of maternal exposure to DMDs on the offspring.
Method
This was a retrospective study revising medical data on the offspring of women with MS. These women now have children aged at least 1 year and include a group of patients that were not exposed to any DMDs for at least 3 months prior to pregnancy and during the whole gestation (control group). Another group of patients had at least 2 weeks of exposure to DMDs, mainly to interferon beta or glatiramer acetate
Results
The women with MS participating in this study have children currently aged, on average, 6.6 years (range 1–39 years). There was no pattern of drug-related adverse events or complications in the children whose mothers were exposed to DMDs. No specific long-term adverse events were observed in the offspring of women with MS who were exposed to drugs during pregnancy. The profile of relevant diagnoses in their children was similar to that of children whose mothers had not been exposed to DMDs.
Conclusions
The present retrospective study did not show a specific profile of long-term deleterious drug effects on children born from mothers who were exposed to drugs for MS treatment.
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References
Borchers AT, Naguwa SM, Keen CL, Gershwin ME. The implications of autoimmunity and pregnancy. J Autoimmun. 2010;34:287–99.
Finkelsztejn A, Brooks JB, Paschoal FM Jr, Fragoso YD. What can we really tell women with multiple sclerosis regarding pregnancy? A systematic review and meta-analysis of the literature. BJOG. 2011;118:790–7.
Lu E, Wang BW, Guimond C, Synnes A, Sadovnick D, Tremlett H. Disease-modifying drugs for multiple sclerosis in pregnancy: a systematic review. Neurology. 2012;79:1130–5.
Fragoso YD, Boggild M, Macias-Islas MA, et al. The effects of long-term exposure to disease-modifying drugs during pregnancy in multiple sclerosis. Clin Neurol Neurosurg. 2013;115:154–9.
Giannini M, Portaccio E, Ghezzi A, et al. Pregnancy and fetal outcomes after glatiramer acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study. BMC Neurol. 2012;12:124.
Hellwig K, Haghikia A, Gold R. Pregnancy and natalizumab: results of an observational study in 35 accidental pregnancies during natalizumab treatment. Mult Scler. 2011;17:958–63.
Schneider H, Weber CE, Hellwig K, Schroten H, Tenenbaum T. Natalizumab treatment during pregnancy - effects on the neonatal immune system. Acta Neurol Scand. 2013;127:1–4.
Kennedy DL, Uhl K, Kweder SL. Pregnancy exposure registries. Drug Saf. 2004;27:215–28.
Fragoso YD, Finkelsztejn A, Comini-Frota ER, et al. Pregnancy and multiple sclerosis: the initial results from a Brazilian database. Arq Neuropsiquiatr. 2009;67:657–60.
Fragoso YD, Finkelsztejn A, Kaimen-Maciel DR, et al. Long-term use of glatiramer acetate by 11 pregnant women with multiple sclerosis: a retrospective, multicentre case series. CNS Drugs. 2010;24:969–76.
Finkelsztejn A, Fragoso YD, Ferreira ML, et al. The Brazilian database on pregnancy in multiple sclerosis. Clin Neurol Neurosurg. 2011;113:277–80.
Howard TB, Tassinari MS, Feibus KB, Mathis LL. Monitoring for teratogenic signals: pregnancy registries and surveillance methods. Am J Med Genet C Semin Med Genet. 2011;157:209–14.
Wettach C, Thomann J, Lambrigger-Steiner C, Buclin T, Desmeules J, von Mandach U. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders. J Perinat Med. 2013;41:301–7.
Mehta U, Clerk C, Allen E, et al. Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings. BMC Pregnancy Childbirth. 2012;12:89.
Gerard E, Pack AM. Pregnancy registries: what do they mean to clinical practice? Curr Neurol Neurosci Rep. 2008;8:325–32.
Acknowledgments
The authors are grateful to Prof. Helen Tremlett from Vancouver, Canada, for the critical review of the manuscript. The invaluable work of our collaborators is acknowledged. Collaborators: Taysa A.G.J. Ribeiro, Liliana Russo, Doralina G.B. Souza, Claudia C.F. Vasconcelos, Sandra M.G. Almeida, Daniella F.R. Bernardes, Juliana Finkelzstejn, Josiane Lopes, Gisele A. Lourenço, Celso L.S. Oliveira, Francisco T.M. Oliveira, Cristiane B. Patroclo, Wildea L.C.J. Pereira, Juliana Safanelli, Alinne M. Sahdo, Patricia C.O. Saldanha, Yves F. Shinzato, Alex E. Silva, Catia Silva, Jorge M.B. Souza, Denis E. Zani.
Conflicts of interest
The authors declare that there are no conflicts of interest and that this study was carried out without any financial support from public or private institutions or companies.
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Fragoso, Y.D., Adoni, T., Alves-Leon, S.V. et al. Long-Term Effects of Exposure to Disease-Modifying Drugs in the Offspring of Mothers with Multiple Sclerosis: A Retrospective Chart Review. CNS Drugs 27, 955–961 (2013). https://doi.org/10.1007/s40263-013-0113-7
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DOI: https://doi.org/10.1007/s40263-013-0113-7