{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T19:15:06Z","timestamp":1791486906499,"version":"4.3.4"},"reference-count":41,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T00:00:00Z","timestamp":1739232000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Since 2015, ferric carboxymaltose (FCM), an intravenous (IV) iron formulation used for treating iron deficiency anemia (IDA), has been associated with an increasing number of reported hypophosphatemia (HPP) cases. Information on HPP clinical manifestations and incidence has not been reviewed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We reviewed HPP\u2010associated adverse events reported to the FDA, case reports, case series, observational databases, clinical trials, meta\u2010analyses, and FDA\u2010approved labels. Our analysis found that FCM\u2010associated HPP is a clinically important adverse drug reaction (ADR). The most common clinical manifestations are general weakness, fatigue, bone pain, muscle pain, osteomalacia, and fractures. Information on rates of FCM\u2010associated HPP was from a review of clinical trials, observational databases, systematic reviews, and meta\u2010analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Clinical trials comparing FCM with other IV iron preparations identified FCM\u2010associated HPP rates between 50% and 92% versus 2% and 8% with other IV iron formulations. Meta\u2010analyses and systematic reviews confirmed these numbers. FDA\u2010approved FCM labels do not include details of available ADR information in case reports, case series, observational databases, randomized trials, and meta\u2010analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We conclude that although the FDA\u2010approved FCM Prescribing Label was updated in 2023, more robust recommendations on FCM\u2010associated HPP are needed to prevent negative outcomes including osteomalacia and fractures. For patient safety, FCM label should advise monitoring serum phosphate levels prior to initiating first doses and before subsequent doses for all patients. Given differences between the FDA\u2010approved FCM label and data reviewed herein, clinicians must be educated about FCM\u2010associated HPP, difficulties treating HPP cases, and should consider administering other IV iron formulations that have lower rates of HPP.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ajh.27598","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T05:34:51Z","timestamp":1739338491000},"page":"840-846","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Ferric Carboxymaltose (<scp>FCM<\/scp>)\u2013Associated Hypophosphatemia (<scp>HPP<\/scp>): A Systematic Review"],"prefix":"10.1002","volume":"100","author":[{"given":"Joseph","family":"Magagnoli","sequence":"first","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR), Clinical Pharmaceutical Outcomes Sciences Department University of South Carolina College of Pharmacy  Columbia South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Knopf","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR), Clinical Pharmaceutical Outcomes Sciences Department University of South Carolina College of Pharmacy  Columbia South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William J.","family":"Hrushesky","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR), Clinical Pharmaceutical Outcomes Sciences Department University of South Carolina College of Pharmacy  Columbia South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth R.","family":"Carson","sequence":"additional","affiliation":[{"name":"The Division of Hematology\/Oncology of the Department of Medicine Northwestern University Feinberg School of Medicine and the Robert H Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8645-5705","authenticated-orcid":false,"given":"Charles L.","family":"Bennett","sequence":"additional","affiliation":[{"name":"The Southern Network on Adverse Reactions (SONAR), Clinical Pharmaceutical Outcomes Sciences Department University of South Carolina College of Pharmacy  Columbia South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,11]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Injectafer Package Insert","year":"2023"},{"key":"e_1_2_9_3_1","volume-title":"Injectafer Package Insert","year":"2013"},{"key":"e_1_2_9_4_1","volume-title":"Injectafer Package Insert","year":"2021"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.1923"},{"key":"e_1_2_9_6_1","first-page":"391","article-title":"Symptomatic Hypophosphataemic Osteomalacia Secondary to the Treatment With Iron Carboxymaltose Detected in Bone Scintigraphy","volume":"35","author":"Sangr\u00f3s Sah\u00fan M. 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