{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T11:15:30Z","timestamp":1788174930135,"version":"build-2803163510"},"reference-count":19,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,7,1]],"date-time":"2021-07-01T00:00:00Z","timestamp":1625097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>In breastfeeding women, anti\u2010epileptic therapy can lead to infant toxicities, even with newer anti\u2010epileptic drugs such as levetiracetam. This study assessed levetiracetam breastmilk excretion and its correlation with the maternal oral dose and serum concentrations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Women with epilepsy treated with levetiracetam were recruited to this study and completed a questionnaire. Levetiracetam concentrations were determined in serial breastmilk samples (pre\u2010dose to 12\u2009h post\u2010dose period) and in a single pre\u2010dose maternal serum sample.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty breastfeeding women and 21 infants (one woman with twins; 16 fully and five partially breastfed infants) participated in this study. The trough breastmilk\/serum ratio of levetiracetam was 0.98\u2009\u00b1\u00a00.20. The infant levetiracetam daily dose was 5.39\u2009\u00b1\u00a01.96 and 2.70\u2009\u00b1\u00a00.98\u2009mg<jats:sup>.<\/jats:sup>kg<jats:sup>\u20101.<\/jats:sup>d<jats:sup>\u22121<\/jats:sup>, and the relative infant dose (RID) was 13.8\u00a0\u00b1\u00a03.1% and 6.9\u00a0\u00b1\u00a01.6% in the fully and partially breastfed infants, respectively. Substantial correlations between the levetiracetam dose, maternal serum and breastmilk trough concentrations, and breastmilk AUC values were found. Three women reported somnolence in their fully breastfed infants, which resolved shortly after switching to partial breastfeeding. All the infants gained weight according to their age.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Infant levetiracetam exposure via the breastmilk was close to the safety thresholds (trough breastmilk\/serum ratio slightly below 1, RID\u2009&gt;\u00a010% in fully breastfed infants), and infant somnolescence reports could be related to exposure of the infants to levetiracetam via breastmilk. Further studies are warranted to reveal the short\u2010 and long\u2010term safety of levetiracetam in breastfeeding.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14940","type":"journal-article","created":{"date-parts":[[2021,6,16]],"date-time":"2021-06-16T02:54:10Z","timestamp":1623812050000},"page":"199-205","source":"Crossref","is-referenced-by-count":14,"title":["Levetiracetam in lactation: How much is excreted into human breast milk?"],"prefix":"10.1111","volume":"88","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3742-3835","authenticated-orcid":false,"given":"Natalie","family":"Dinavitser","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"},{"name":"Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elkana","family":"Kohn","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maya","family":"Berlin","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nurit","family":"Brandriss","sequence":"additional","affiliation":[{"name":"Biochemistry Laboratory, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adina","family":"Bar\u2010Chaim","sequence":"additional","affiliation":[{"name":"Biochemistry Laboratory, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rimona","family":"Keidar","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayelet","family":"Livne","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7206-8352","authenticated-orcid":false,"given":"David","family":"Stepensky","sequence":"additional","affiliation":[{"name":"Department of Clinical Biochemistry and Pharmacology, Faculty of Health Sciences Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matitiahu","family":"Berkovitch","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Revital","family":"Sheinberg","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir (Assaf Harofeh) Medical Center, affiliated to the Sackler School of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252807.38124.a3"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181a6b2f8"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2011-3552"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2013.08.016"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12884"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/pch\/9.8.575"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-8624.1996.tb01871.x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmwh.2007.09.004"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2007.01032.x"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2007.11.027"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2009.04.006"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1535-7511.2005.00085.x"},{"issue":"7","key":"e_1_2_10_14_1","first-page":"447","article-title":"Therapeutic and toxic blood concentrations of more than 800 drugs and other xenobiotics","volume":"58","author":"Schulz M","year":"2003","journal-title":"Pharmazie"},{"key":"e_1_2_10_15_1","volume-title":"Drugs and human lactation: a guide to the content and consequences of drugs, micronutrients, radiopharmaceuticals and environmental and occupational chemicals in human milk","author":"Bennett PN","year":"1988"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2005.54804.x"},{"key":"e_1_2_10_17_1","first-page":"105","article-title":"Levetiracetam accumulation in human breast milk","volume":"43","author":"Kramer G","year":"2002","journal-title":"Epilepsia"},{"key":"e_1_2_10_18_1","volume-title":"Keppra (levetiracetam) tablets and oral solution [prescribing information]","year":"2019"},{"key":"e_1_2_10_19_1","first-page":"1","article-title":"Infant drug exposure via breast milk","author":"Verstegen RHJ","year":"2020","journal-title":"Br J Clin Pharmacol"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2019.4443"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14940","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcp.14940","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.14940","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T17:03:08Z","timestamp":1693242188000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.14940"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1111\/bcp.14940"],"URL":"https:\/\/doi.org\/10.1111\/bcp.14940","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7]]}}}