title: Incidence of side-effects associated with high-dose ferric gluconate in patients with severe chronic renal failure.
abstract: Ferric gluconate complex in sucrose (Ferrlecit) has been associated with less side-effects than iron dextran; however, the recommended dose of 62.5-125 mg per treatment is only suitable for haemodialysis (HD) patients. We retrospectively analysed the incidence of the side-effects associated with a high dose of Ferrlecit infusion (20 treatments in 13 patients; 10 treatments of 250 mg/3-4 h, and 10 treatments of 500 mg/5 h infusion). The patients were in the age range of 32-75 years old, seven with chronic renal failure (CRF), and six on dialysis treatment. One (10%) of the 10 treatments using a 250 mg dose was complicated with severe nausea/vomiting, diarrhoea and a burning sensation in the feet. Three (30%) of the 10 treatments using a 500 mg dose were complicated with: chills, severe nausea/vomiting, hypotension and syncope in one; severe nausea/vomiting, diarrhoea and hypotension in one; and an episode of vomiting in one patient. A single treatment with a 250 mg dose resulted in no significant change in haematological parameters. A single treatment with a 500 mg dose resulted in a significant increase in haemoglobin (Hgb) and haematocrit (Hct), but only a rising trend in serum iron,% transferrin saturation and ferritin pre versus 1-2 months postinfusion. In conclusion, Ferrlecit doses of 250 or 500 mg are complicated with significant untoward reactions in 10-30% of patients, in a dose-dependent fashion.
authors.affiliation: Division of Nephrology, Saint Louis University School of Medicine, Saint Louis, Missouri, USA. bastanbi@slu.edu
authors.forename: Bahar
authors.initials: B
authors.lastname: Bastani
authors.forename: Anil
authors.initials: A
authors.lastname: Jain
authors.forename: Gopal
authors.initials: G
authors.lastname: Pandurangan
mesh_terms: D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005290:Ferric Compounds / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D005290:Ferric Compounds; C035552:ferric gluconate