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Letter to the Editor

"Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid": Not So Safe

The Joseph Michaeli Department of Hematology, Barzilai Medical Center, Ashkelon, Israel

Correspondence: Gilles Lugassy, M.D., The Joseph Michaeli Department of Hematology, Barzilai Medical Center, Ashkelon, Israel. Telephone: 97286745794; Fax: 97286745490; e-mail: brzgil{at}barzi.health.gov.il

In their paper, "Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid," Berenson and Hirschberg [1] do, in fact, review the beneficial effects of long-term palliative therapy with bisphosphonates to reduce the skeletal morbidity associated with malignant bone disease. The authors emphasize the safety of chronic i.v. administration of the newer bisphosphonates, pamidronate (Aredia^®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, http://www.pharma.us.novartis.com) and zoledronic acid (Zometa^®; Novartis Pharmaceuticals Corporation), and justify the title of their article with a short paragraph on the convenience of a 15-minute versus a 2-hour infusion. Nevertheless, a whole chapter is missing in the review, which concerns the serious and worrisome complications recently described during bisphosphonate therapy. Chang et al. [2], from the U.S. Food and Drug Administration, reported no fewer than 72 patients who developed renal failure associated with zoledronic acid, of whom 27 required dialysis and 18 died. Acute tubular necrosis has also been described in association with zoledronic acid therapy [3]. None of these very serious events are described in the Berenson and Hirschberg [1] review.

Also in 2003, Marx [4] reported a "growing epidemic" of pamidronate- and zoledronate-induced avascular necrosis of the jaws. Thirty-six cases were described—24 of these had been treated with pamidronate, six had been treated with zoledronate, and six had received both therapies successively. More cases have been reported since then by Migliorati [5] and Schwartz [6].

We recently reported the first three cases of osteomyelitis of the jaw among myeloma patients chronically treated with both pamidronate and zoledronate [7]. In Israel alone, 12 more patients with osteomyelitis of the jaw related to bisphosphonate therapy have been reported to us since publication of these first cases.

We are convinced that a comprehensive review on the safety of chronic bisphosphonate therapy should have included all these complications in order to prevent their related potential morbidity and mortality.

	DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST

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The author indicated no potential conflicts of interest.

	REFERENCES

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1. Berenson J, Hirschberg R. Safety and convenience of a 15-minute infusion of zoledronic acid. The Oncologist 2004;9:319–329.[Abstract/Free Full Text]
2. Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid. N Engl J Med 2003;349:1676–1679.[Free Full Text]
3. Markowitz GS, Fine PL, Stack JI et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 2003;64:281–289.[CrossRef][Medline]
4. Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg 2003;61:1115–1117.[CrossRef][Medline]
5. Migliorati CA. Bisphosphonates and oral cavity avascular bone necrosis. J Clin Oncol 2003;21:4253–4254.[Free Full Text]
6. Schwartz HC. Osteonecrosis and bisphosphonates: correlation versus causation. J Oral Maxillofac Surg 2004;62:763–764.
7. Lugassy G, Shaham R, Nemets A et al. Severe osteomyelitis of the jaw in long-term survivors of multiple myeloma: a new clinical entity. Am J Med 2004;117:440–441.[CrossRef][Medline]

This article has been cited by other articles:

				T. Van den Wyngaert, M. T. Huizing, and J. B. Vermorken Bisphosphonates and osteonecrosis of the jaw: cause and effect or a post hoc fallacy? Ann. Onc., August 1, 2006; 17(8): 1197 - 1204. [Abstract] [Full Text] [PDF]

				B. A. Chabner Late Toxicities of Drugs: Bisphosphonates Oncologist, May 1, 2005; 10(5): 301 - 303. [Full Text] [PDF]

				J. Berenson Response to Letters to the Editor from Lugassy and Balla Regarding "Safety and Convenience of a 15-Minute Infusion of Zoledronic Acid" Oncologist, May 1, 2005; 10(5): 311 - 312. [Full Text] [PDF]

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