FDA Strengthens Kidney Risk Warning for Reclast

Disclosures

September 01, 2011

September 1, 2011 — Zoledronic acid (Reclast, Novartis Pharmaceuticals), an injectable bisphosphonate used to prevent and treat osteoporosis, is now contraindicated for patients with creatinine clearance below 35 mL/min or evidence of acute renal impairment, according to a label change announced today by the US Food and Drug Administration (FDA).

The revision, which also includes an updated warning on kidney impairment, comes in the wake of continued cases of fatal acute renal failure associated with the drug.

Novartis Pharmaceuticals also sells zoledronic acid under the brand name Zometa as a treatment of cancer-related indications, but the labeling changes unveiled today apply only to Reclast. The label for Zometa already contains a warning about renal toxicity.

Patients who take zoledronic acid and have underlying moderate to severe renal impairment are at risk for renal failure — a rare adverse event — and this risk increases with age, according to the agency. Other risk factors for renal failure are severe hydration occurring before or after infusion with zoledronic acid and concurrent use of kidney-damaging or diuretic medications.

In 2009, an FDA postmarket safety review identified 5 patients who died of acute renal failure after being treated with zoledronic acid. The FDA revised the drug’s label that year to include reports of renal impairment from clinical studies, and a recommendation to monitor serum creatinine before each infusion of the drug.

Another agency review earlier this year identified 11 more fatal cases of acute renal failure after zoledronic-acid infusion, as well as 9 cases of renal injury that required dialysis.

The FDA is advising clinicians to continue to screen patients prior to each dose of zoledronic acid to spot those with underlying acute or chronic renal impairment, or dehydration, and to pay attention to their age.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to zoledronic acid, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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