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ONCOLOGY

Zoledronic Acid and Renal Toxicity: Data from French Adverse Effect Reporting Database

Pharmacy Resident, Service de Pharmacologie Clinique, Regional Pharmacovigilance Center, Amiens University Hospital (CHU) d'Amiens, Amiens, France

Valerie Gras, PharmD

Pharmacist, Service de Pharmacologie Clinique, Regional Pharmacovigilance Center, CHU d'Amiens

Michel Andrejak, MD

Professor, Head of Department, Service de Pharmacologie Clinique, Regional Pharmacovigilance Center, CHU d'Amiens

Nathalie Bernard, PharmD

Pharmacist, Regional Pharmacovigilance Center, CHU de Lyon, Lyon, France

Marie-Josephe Jean-Pastor, MD

Staff Physician, Regional Pharmacovigilance Center, CHU de Marseille, Marseille, France

Sophie Gautier, PharmD

Pharmacist, Regional Pharmacovigilance Center, CHU de Lille, Lille, France

Michel Biour, MD

Staff Physician, Regional Pharmacovigilance Center, University Hospital Saint Antoine, Paris, France

Ziad Massy, MD PhD

Professor, Services de Pharmacologie Clinique et de Néphrologie, CHU d'Amiens SUD

Reprints: Pr. Massy, Services de Pharmacologie Clinique et de Néphrologie, CHU d'Amiens SUD, Avenue René Laennec, 80054 Amiens Cedex 1, France, fax 33-3-22-45-57-60, massy{at}u-picardie.fr

BACKGROUND: Zoledronic acid–associated renal impairment leading to renal failure has been recently reported in a cohort of US patients. However, the presence of such toxicity in other populations has not yet been determined.

OBJECTIVE: To analyze French cases of zoledronic acid–associated nephrotoxicity.

METHODS: We evaluated available cases with acute deterioration of renal function associated with zoledronic acid therapy drawn from the French Adverse Event Reporting System database until July 1, 2004.

RESULTS: We identified 4 men and 3 women between the ages of 52 and 70 years, with multiple myeloma or different types of metastatic cancer, who had experienced renal impairment during zoledronic acid therapy. Four patients developed de novo acute renal failure, while the other 3 patients experienced acute deterioration of preexisting chronic renal failure. Renal failure occurred after various durations of zoledronic acid therapy (1–120 days). Three patients completely recovered and one partially recovered their previous renal function after discontinuation of zoledronic acid, but renal impairment was associated with a fatal outcome in 2 cases; the outcome of the other case was unknown. Our data confirm the previously reported risk factors for zoledronic acid–associated nephrotoxicity such as advanced cancer, multiple myeloma, preexisting renal failure, diabetes, hypertension, and concomitant use of nephrotoxic drugs.

CONCLUSIONS: These cases emphasize the need for regular monitoring of renal function during zoledronic acid treatment, with particular attention to patients with preexisting impaired renal function.

Key Words: zoledronic acid, bisphosphonates: nephrotoxicity, tubular necrosis

Published Online, June 14, 2005. www.theannals.com, DOI 10.1345/aph.1E589

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