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Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia
Author(s) -
BAILIE George R.,
MASON Nancy A.,
VALAORAS Thomas G.
Publication year - 2010
Publication title -
hemodialysis international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.658
H-Index - 47
eISSN - 1542-4758
pISSN - 1492-7535
DOI - 10.1111/j.1542-4758.2009.00409.x
Subject(s) - tolerability , medicine , placebo , adverse effect , anemia , clinical endpoint , iron deficiency anemia , iron deficiency , randomized controlled trial , alternative medicine , pathology
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.