Abstract There is limited safety information about ferric carboxymaltose (FCM), a new intravenous iron preparation. This randomized, crossover study compared the safety and tolerability of double-blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia. Subjects (559) with iron deficiency anemia received a dose of either FCM (15 mg\/kg, maximum 1000 mg) over 15 minutes or placebo on day 0. On day 7, subjects received the other agent. Safety evaluations were performed on days 7 and 14. The primary endpoint was the incidence of treatment-emergent adverse events during each 7-day study period. During the first 24 hours and during the 7-day treatment period, at least one treatment-emergent adverse event was experienced by 15.0% and 29.3% of subjects after FCM and 11.4% and 19.7% after placebo, respectively. Most were classified as Grade 1 or 2. Six subjects had Grade 3 treatment-emergent adverse events after FCM and 9 subjects after placebo. One subject had a Grade 4, and 1 subject had a Grade 5 treatment-emergent adverse event, but neither was considered study drug-related. During the first 24 hours of the treatment period, drug-related adverse events were reported in 9.3% of subjects receiving FCM and 4.8% receiving placebo. Of drug-related Grade 3 events, 4 subjects received FCM and 5 subjects received placebo. Administration of FCM (15 mg\/kg, maximum of 1000 mg) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia.\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Editorial: Hemodial Int Fecha: 01\/11\/2009 Bailie GR, Mason NA, Valaoras TG. Acceso al enlace publicador Abstract There is limited safety<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[4],"tags":[],"_links":{"self":[{"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/posts\/365"}],"collection":[{"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/comments?post=365"}],"version-history":[{"count":1,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/posts\/365\/revisions"}],"predecessor-version":[{"id":701,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/posts\/365\/revisions\/701"}],"wp:attachment":[{"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/media?parent=365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/categories?post=365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/awge.doctime.es\/index.php\/wp-json\/wp\/v2\/tags?post=365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}