Zoledronic Acid and renal toxicity: data from French adverse effect reporting database.
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.
Munier
Aline
A
Service de Pharmacologie Clinique, Regional Pharmacovigilance Center, Amiens University Hospital (CHU) d'Amiens, Amiens, France.
Gras
Valerie
V
Andrejak
Michel
M
Bernard
Nathalie
N
Jean-Pastor
Marie-Josephe
MJ
Gautier
Sophie
S
Biour
Michel
M
Massy
Ziad
Z
D058186:Acute Kidney Injury / Q000139:chemically induced; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D001862:Bone Resorption / Q000188:drug therapy*; D016208:Databases, Factual; D004164:Diphosphonates / Q000009:adverse effects*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects*; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D009102:Multiple Organ Failure / Q000139:chemically induced; D009369:Neoplasms / Q000150:complications; D000077211:Zoledronic Acid
D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid