{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T00:52:02Z","timestamp":1776905522022,"version":"3.51.2"},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T00:00:00Z","timestamp":1774396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T00:00:00Z","timestamp":1774396800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Obstet and Gynaecol"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>This post\u2010marketing surveillance study determined the real\u2010world use and safety of ferric citrate hydrate (FC) in fetuses and pregnant women with iron deficiency anemia (IDA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pregnant women with IDA were registered centrally and followed prospectively from the first FC administration until the end of pregnancy or at treatment discontinuation. Demographic characteristics, FC administration, and levels of iron\u2010 and anemia\u2010related parameters were collected. Newborns were followed for 7\u2009days after birth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Registration was from October 2021 to March 2023, and 149 women and 129 newborns were included for analysis. The mean (standard deviation; SD) age of the women was 32.1 (5.1) years, and 75.8% were at \u2265\u200928\u2009weeks of gestational age at the first FC administration. The mean (SD) daily dose of FC was 494.2 (36.3) mg. FC treatment was continued until the end of pregnancy in 53 of 149 women (35.6%). The most frequent reason for the discontinuation of FC (96\/149 women, 64.4%) was an improvement in IDA (68\/149 women, 45.6%). Adverse drug reactions (ADRs) led to discontinuation in 4 of 149 women (2.7%). In 7 of 149 women (4.7%), 9 ADRs were found, including constipation (3\/149, 2.0%), nausea (2\/149, 1.3%), abdominal pain upper (1\/149, 0.7%), diarrhea (1\/149, 0.7%), hand dermatitis (1\/149, 0.7%), and fetal death (1\/149, 0.7%). No ADRs were found in newborns. Hemoglobin and serum ferritin levels were increased with FC treatment, but no signs of iron overload were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>No previously unknown safety concerns were detected in women, fetuses, or newborns by FC treatment during pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>jRCT2031210322<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jog.70243","type":"journal-article","created":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T04:36:23Z","timestamp":1774499783000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety of Ferric Citrate Hydrate in Pregnant Women With Iron Deficiency Anemia, Fetuses, and Newborns: A Real\u2010World, Observational, Post\u2010Marketing Surveillance Study"],"prefix":"10.1111","volume":"52","author":[{"given":"Shinichiro","family":"Suzuki","sequence":"first","affiliation":[{"name":"Pharmaceutical Division Japan Tobacco Inc.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teruo","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Pharmaceutical Division Japan Tobacco Inc.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuri","family":"Okuda","sequence":"additional","affiliation":[{"name":"Pharmaceutical Division Japan Tobacco Inc.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3258-4429","authenticated-orcid":false,"given":"Kyoko","family":"Ito","sequence":"additional","affiliation":[{"name":"Medical Affairs Department Torii Pharmaceutical Co. Ltd.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sayaka","family":"Ito","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Torii Pharmaceutical Co., Ltd.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiko","family":"Shigeta","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Torii Pharmaceutical Co., Ltd.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuki","family":"Goto","sequence":"additional","affiliation":[{"name":"Pharmaceutical Division Japan Tobacco Inc.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eiji","family":"Horikawa","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Torii Pharmaceutical Co., Ltd.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriaki","family":"Nishino","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Torii Pharmaceutical Co., Ltd.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-0408-5131","authenticated-orcid":false,"given":"Ryoichi","family":"Yamada","sequence":"additional","affiliation":[{"name":"Pharmaceutical Division Japan Tobacco Inc.  Chuo\u2010ku Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,3,25]]},"reference":[{"key":"e_1_2_13_2_1","volume-title":"Guideline on Haemoglobin Cutoffs to Define Anaemia in Individuals and Populations","author":"World Health Organization","year":"2024"},{"key":"e_1_2_13_3_1","volume-title":"Iron Deficiency Anaemia: Assessment, Prevention and Control. A Guide for Programme Managers","author":"United Nations Children's Fund, United Nations University, World Health Organization","year":"2001"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.3945\/ajcn.117.155812"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2020.03.006"},{"key":"e_1_2_13_6_1","article-title":"Daily Oral Iron Supplementation During Pregnancy","volume":"2015","author":"Pe\u00f1a\u2010Rosas J. P.","year":"2015","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.12669\/pjms.323.9799"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-021-03123-9"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2016101053"},{"key":"e_1_2_13_10_1","unstructured":"Torii Pharmaceutical Co. Ltd.\u201cInterview Form for Riona Tab. 250 mg [Japanese] \u201d2025 https:\/\/pins.japic.or.jp\/pdf\/medical_interview\/IF00007734.pdf."},{"key":"e_1_2_13_11_1","volume-title":"Guidelines for Anemia Treatment by Proper Use of Iron Preparations","author":"The Japanese BioIron Society","year":"2015"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40064-016-2365-4"},{"key":"e_1_2_13_13_1","first-page":"137","article-title":"Post\u2010Marketing Study on Sodium Ferrous Citrate (FERROMIA)\u2014In Depth Clinical Experience Investigation on Age and Pregnancy","author":"Saiki T.","year":"1992","journal-title":"Iyakuhin Kenkyu"},{"key":"e_1_2_13_14_1","unstructured":"Ministry of Health Labour and Welfare of Japan \u201cSummary of Vital Statistics \u201dhttps:\/\/www.mhlw.go.jp\/english\/database\/db\u2010hw\/populate\/dl\/E02.pdf."},{"key":"e_1_2_13_15_1","unstructured":"Eisai Co. Ltd.\u201cPackage Insert for Ferromia\u00ae Tablets 50 mg and Ferromia\u00ae Granules 8.3% [Japanese] \u201d2025 https:\/\/pins.japic.or.jp\/pdf\/newPINS\/00054284.pdf."},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2024013408"}],"container-title":["Journal of Obstetrics and Gynaecology Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jog.70243","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jog.70243","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jog.70243","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T00:15:23Z","timestamp":1776903323000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/jog.70243"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,25]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1111\/jog.70243"],"URL":"https:\/\/doi.org\/10.1111\/jog.70243","archive":["Portico"],"relation":{},"ISSN":["1341-8076","1447-0756"],"issn-type":[{"value":"1341-8076","type":"print"},{"value":"1447-0756","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,25]]},"assertion":[{"value":"2025-06-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-04","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70243"}}