Safety profile of a high dose ferric gluconate in patients with severe chronic renal insufficiency

J Nephrol. Nov-Dec 2002;15(6):681-3.

Abstract

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.

Conclusion: 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.

MeSH terms

  • Adult
  • Aged
  • Anemia, Iron-Deficiency / drug therapy*
  • Anemia, Iron-Deficiency / etiology
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Ferric Compounds / administration & dosage*
  • Ferric Compounds / adverse effects*
  • Follow-Up Studies
  • Humans
  • Infusions, Intravenous
  • Kidney Failure, Chronic / diagnosis*
  • Kidney Failure, Chronic / drug therapy*
  • Kidney Failure, Chronic / therapy
  • Male
  • Maximum Tolerated Dose*
  • Middle Aged
  • Renal Dialysis / adverse effects
  • Renal Dialysis / methods
  • Retrospective Studies
  • Risk Assessment
  • Treatment Outcome

Substances

  • Ferric Compounds
  • ferric gluconate