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Clinical data were collated from the Eisai global perampanel safety database, comprising reports of perampanel exposure during pregnancy from routine clinical settings, interventional studies, and non\u2010interventional post\u2010marketing studies, searched for events coded to Medical Dictionary for Regulatory Activities (MedDRA) high\u2010level group terms of Pregnancy, Labor, Delivery, and Postpartum Conditions and\/or the Standardized MedDRA Query terms of Congenital, Familiar, and Genetic Disorders. A PBPK model was used to predict clinical perampanel PK throughout pregnancy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Preclinical studies indicated that perampanel may be linked with post\u2010implantation loss and\/or some specific physical development delays but not fertility and early embryonic development. As of August 31, 2018, 96 pregnancies in 90 women receiving perampanel had been reported. No concomitant medications were reported in 26 (28.9%) women taking perampanel. Overall, 43 pregnancies reached full term (all normal live births), 28 did not reach term (induced abortion, <jats:italic>n\u00a0=\u00a018<\/jats:italic>; spontaneous miscarriage, <jats:italic>n<\/jats:italic>\u00a0=\u00a06; incomplete spontaneous miscarriage, <jats:italic>n<\/jats:italic>\u00a0=\u00a02; premature delivery, <jats:italic>n<\/jats:italic>\u00a0=\u00a01; stillbirth [Fallot\u2019s tetralogy], <jats:italic>n<\/jats:italic>\u00a0=\u00a01), 18 were lost to follow\u2010up, and seven were ongoing at data cut\u2010off. Adverse events were reported in five\u00a0full\u2010term neonates (low Apgar score, <jats:italic>n<\/jats:italic>\u00a0=\u00a02; fatal neonatal aspiration, <jats:italic>n<\/jats:italic>\u00a0=\u00a01; cystic fibrosis and congenital deafness, <jats:italic>n<\/jats:italic>\u00a0=\u00a01; poor sucking reflex and shallow breathing, <jats:italic>n<\/jats:italic>\u00a0=\u00a01). PK simulations predicted perampanel exposure decreases throughout pregnancy and is up to four\u2010 and three\u2010fold lower towards the end of pregnancy compared with non\u2010pregnant women for total and unbound perampanel, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>These data provide preliminary information on perampanel use during pregnancy and should be interpreted with caution. Further outcome data are required to estimate the prevalence of adverse pregnancy outcomes with perampanel exposure.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.16821","type":"journal-article","created":{"date-parts":[[2021,3,5]],"date-time":"2021-03-05T15:54:43Z","timestamp":1614959683000},"page":"698-708","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Perampanel and pregnancy"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1151-6681","authenticated-orcid":false,"given":"Blanca","family":"Vazquez","sequence":"first","affiliation":[{"name":"NYU Langone Comprehensive Epilepsy Center New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0554-5352","authenticated-orcid":false,"given":"Torbj\u00f6rn","family":"Tomson","sequence":"additional","affiliation":[{"name":"Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Dobrinsky","sequence":"additional","affiliation":[{"name":"Eisai Inc. Woodcliff Lake New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edgar","family":"Schuck","sequence":"additional","affiliation":[{"name":"Eisai Inc. Woodcliff Lake New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7198-8621","authenticated-orcid":false,"given":"Terence J.","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Central Clinical School The Alfred Hospital, Monash University Melbourne Victoria Australia"},{"name":"Department of Medicine The Royal Melbourne Hospital, The University of Melbourne Parkville Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,5]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.7717\/peerj.7115"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-017-0845-1"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2015.1017"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2004.04.025"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002160"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ppe.12004"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12109"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2014.05.004"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2012.03712.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002446"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008001"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2007.01412.x"},{"key":"e_1_2_10_14_1","unstructured":"European Medicines Agency.Fycompa\u00ae. 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