{
    "abstract": "Epilepsy is a common neurologic disorder requiring continued treatment during pregnancy. Treatment with antiepileptic drugs (AEDs) is needed for seizure control, but the risk of adverse events has to be minimized for both mother and foetus. Available data on pregnancy and foetal/postnatal outcomes following eslicarbazepine acetate (ESL) exposure via parent is herein presented for the first time.\nESL's global safety database was reviewed to identify pregnancy cases with exposure to ESL reported up to October 21st, 2017. The EMBASE\u2122 and MEDLINE\nOverall, 91 notifications of pregnancy were identified, of which 79 involved ESL exposure: 28 during clinical trials and 51 from 8-years of post-marketing surveillance. Thirty pregnancies resulted in live birth without congenital anomalies; in 25 pregnancies the outcome was ongoing and 3 was unknown; 18 cases resulted in abortion (10 spontaneous and 8 induced) and congenital anomalies were identified in 5 cases (no clear relationship with ESL was established). ESL was used concomitantly to other AEDs in 11 of the 15 pregnancies for which the outcome was spontaneous abortion and congenital anomaly. Literature review did not yield additional information.\nAvailable data are insufficient to draw conclusions regarding ESL use during pregnancy. Although no particular safety problem was identified, ESL exposure during pregnancy will continue to be monitored and evaluated.",
    "authors": [
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Raquel",
            "initials": "R",
            "lastname": "Costa"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Lu\u00eds M",
            "initials": "LM",
            "lastname": "Magalh\u00e3es"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Joana",
            "initials": "J",
            "lastname": "Gra\u00e7a"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Mariana",
            "initials": "M",
            "lastname": "Vieira"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1). Electronic address: helena.gama@bial.com.",
            "firstname": "Helena",
            "initials": "H",
            "lastname": "Gama"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Joana",
            "initials": "J",
            "lastname": "Moreira"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1).",
            "firstname": "Jos\u00e9 F",
            "initials": "JF",
            "lastname": "Rocha"
        },
        {
            "affiliation": "Dept. Research & Development, BIAL - Portela & C(a),, S.A., 4745-457 Coronado (S. Rom\u00e3o e S. Mamede), Portugal(1); Dept. of Biomedicine, Pharmacology and Therapeutics Unit, Faculty of Medicine, University Porto, Porto, Portugal; MedInUP, Center for Drug Discovery and Innovative Medicines, University Porto, Porto, Portugal.",
            "firstname": "Patr\u00edcio",
            "initials": "P",
            "lastname": "Soares-da-Silva"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.",
    "doi": "10.1016/j.seizure.2018.04.007",
    "journal": "Seizure",
    "keywords": [
        "Antiepileptic drug",
        "Epilepsy",
        "Eslicarbazepine acetate",
        "Pregnancy"
    ],
    "methods": null,
    "publication_date": "2018-04-21",
    "pubmed_id": "29674237",
    "results": "Overall, 91 notifications of pregnancy were identified, of which 79 involved ESL exposure: 28 during clinical trials and 51 from 8-years of post-marketing surveillance. Thirty pregnancies resulted in live birth without congenital anomalies; in 25 pregnancies the outcome was ongoing and 3 was unknown; 18 cases resulted in abortion (10 spontaneous and 8 induced) and congenital anomalies were identified in 5 cases (no clear relationship with ESL was established). ESL was used concomitantly to other AEDs in 11 of the 15 pregnancies for which the outcome was spontaneous abortion and congenital anomaly. Literature review did not yield additional information.",
    "title": "Eslicarbazepine acetate exposure in pregnant women with epilepsy.",
    "xml": "<Element 'PubmedArticle' at 0x788506f591c0>"
}