Correspondence
Renal Failure with the Use of Zoledronic Acid
N Engl J Med 2003; 349:1676-1679October 23, 2003
- Article
To the Editor:
Zoledronic acid (Zometa, Novartis Pharmaceuticals) is a potent bisphosphonate that inhibits bone resorption. In trials of treatment for bone metastases, 9 to 15 percent of the patients who received 4 mg of zoledronic acid over a 15-minute period had renal deterioration, defined by elevations in the serum creatinine level.1,2 With marketed use of the drug, renal deterioration progressing to renal failure and dialysis has been reported. Although the causes of renal deterioration are multifactorial, acute tubular necrosis has been described as a potential mechanism associated with zoledronic acid.3
We identified 72 cases in the Food and Drug Administration (FDA) Adverse Event Reporting System from August 2001 to March 2003 in which physicians reported renal failure associated with zoledronic acid (Table 1Table 1
Demographic Characteristics of the Patients.). Our case series consisted of a heterogeneous group of patients, including 42 patients with multiple myeloma, 22 with solid tumors, 2 with benign conditions, and 6 with unknown diagnoses. The demographic characteristics and outcomes were similar for patients with and those without multiple myeloma. Treatment details, including hydration status, were not uniformly reported. In the 35 cases for which information on the frequency of retreatment was provided, all the patients received the additional doses appropriately, except for three patients with multiple myeloma who were retreated by the same physician more frequently than every three to four weeks. Thirty-nine patients had serum creatinine levels at or above 1.4 mg per deciliter, including four patients in whom the level was above 3.0 mg per deciliter. Forty-five patients were in stable condition while receiving pamidronate, before switching to zoledronic acid. Of the 72 patients, 27 required dialysis and 18 died. Underlying risk factors for renal deterioration, including advanced cancer, previous bisphosphonate exposure, and use of nonsteroidal antiinflammatory medications, may have contributed to the progression of renal failure.Renal failure developed after an average of 56 days of zoledronic acid use. Eighteen patients (25 percent) received only one dose of zoledronic acid and had renal failure after an average of 11 days. In six patients who had not previously taken a bisphosphonate, renal failure developed after an average of 20 days. The onset of renal failure and the recovery of serum creatinine levels after drug discontinuation suggest a temporal relation to the use of zoledronic acid.
Although underreporting is substantial with voluntary adverse-event reporting systems,4 the FDA has received reports of renal deterioration progressing to renal failure and dialysis with the use of zoledronic acid. Because of the serious nature of these events, health care professionals should monitor renal function before each dose of zoledronic acid is administered, provide adequate hydration, and discontinue treatment if renal function deteriorates.
4 ReferencesJennie T. Chang, Pharm.D.
Lanh Green, Pharm.D., M.P.H.
Julie Beitz, M.D.
Food and Drug Administration, Rockville, MD 20857
changj@cder.fda. gov 1
Zometa product label. East Hanover, N.J.: Novartis Pharmaceuticals, 2002. (Accessed October 3, 2003, at http://www.us.zometa.com/info/about/index.jsp.)
2
Ibrahim A ,Scher N ,Williams G , et al. Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. Clin Cancer Res 2003;9:2394-2399
Web of Science | Medline3
Markowitz GS ,Fine PL ,Stack JI , et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 2003;64:281-289
CrossRef | Web of Science | Medline4
Scott HD ,Rosenbaum SE ,Waters WJ , et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987;70:311-316
Medline
Author/Editor Response
The above letter was referred to Novartis Pharmaceuticals, the manufacturer of zoledronic acid, which offers the following reply:
To the Editor: We agree with the conclusion of Chang et al. that for the appropriate care of patients with cancer, it is essential to monitor renal function when using any intravenous bisphosphonate. However, their letter does not fully convey the clinical context and complexities of treating patients with metastatic cancer who have poor prognoses.
As the developer of two intravenous bisphosphonates, pamidronate and zoledronic acid, we have amassed considerable experience with this class of drugs. During the period monitored by Chang et al., more than 430,000 patients received zoledronic acid treatment. Spontaneous reports of renal deterioration received by the sponsor have been uncommon, and the relative incidence of such reports has decreased with increased use of the product. The rate of renal deterioration that Chang et al. cited in the letter for zoledronic acid (9 to 15 percent)1 should be considered in the context of the rate of renal deterioration among patients in the placebo groups of the same trials (6.7 to 11.5 percent). This confirms the increased base-line risk of renal deterioration, including renal failure, in patients with advanced or metastatic cancer.2 Because intravenous bisphosphonates have been associated with a risk of renal deterioration, specific guidelines for renal monitoring are included in the product labeling.
Renal deterioration in patients with cancer can be caused by multiple factors, including advancing or progressive cancer, chemotherapy, previous bisphosphonate therapy, administration of concomitant nephrotoxic medications, and coexisting conditions, such as severe dehydration, chronic renal failure, hypertension, or diabetes.2,3 For example, 45 of the 72 patients described in the letter had been treated with pamidronate previously, on a long-term basis (mean duration of treatment, 600 days). These risk factors are also reflected in the spontaneous reports of renal deterioration we receive.
Two unusual cases involving patients with “benign conditions” were included. The first patient (who had Paget's disease of bone) inappropriately received excessive bisphosphonate (monthly doses over a period of many months)4; the second patient, treated experimentally, was predisposed to renal failure because of excessive calcium ingestion.
In summary, zoledronic acid provides important clinical benefits for patients with bone metastases and has an established safety profile when used appropriately. We support the recommendation by Chang et al., as described in the prescribing information for patients with metastatic cancer: regular monitoring of renal function, adequate hydration, and discontinuation of treatment if renal function deteriorates.
4 ReferencesPeter Tarassoff, M.D., Ph.D.
Yong-Jiang Hei, M.D., Ph.D.
Dionigi Maladorno, M.D.
Novartis Pharmaceuticals, East Hanover, NJ 07936
peter.tarassoff@pharma. novartis. com 1
Ibrahim A ,Scher N ,Williams G , et al. Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases. Clin Cancer Res 2003;9:2394-2399
Web of Science | Medline2
Weinman EJ ,Patak RV . Acute renal failure in cancer patients. Oncology (Huntingt) 1992;6:47-52
Medline3
Kintzel PE . Anticancer drug-induced kidney disorders. Drug Saf 2001;24:19-38
CrossRef | Web of Science | Medline4
Markowitz GS ,Fine PL ,Stack JI , et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 2003;64:281-289
CrossRef | Web of Science | Medline
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