Safety profile of a high dose ferric gluconate in patients with severe chronic renal insufficiency.
BACKGROUND
Iron deficiency is a common and important cause of poor response to erythropoietin in patients with severe chronic renal failure (CRF). Oral iron supplements fail to correct iron deficiency in these patients. Ferric gluconate has a low side effect profile, however the recommended dose of 62.5 to 125 mg per treatment is not practical for patients who are not on hemodialysis (HD).


METHODS
We retrospectively analyzed the incidence rate of side effects associated with 250 mg of ferric gluconate infused over 1 to 4 hrs. Seventy-nine treatments were administered to 40 patients who had severe CRF. Five patients had received treatments on consecutive days (2 to 4 treatments).


RESULTS
Four treatments in two patients were associated with side effects, which included diarrhea, vomiting, low back pain, hypotension and burning sensation in feet. The duration of infusion did not influence the side effect profile.


CONCLUSIONS
Our preliminary results suggest that 250 mg of ferric gluconate infused over 14 hrs may be safe with infrequent side effects (5%). It is also more convenient and practical for patients who are not on maintenance HD.
Jain
Anil K
AK
Division of Nephrology, Saint Louis University School of Medicine, Saint Louis, MO 63017, USA.
Bastani
Bahar
B
D000328:Adult; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007676:Kidney Failure, Chronic / Q000175:diagnosis* / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects / Q000379:methods; D012189:Retrospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome
D005290:Ferric Compounds; C035552:ferric gluconate