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FDA Boosts Reclast Kidney Failure Warnings

Sep 2, 2011 | Parker Waichman LLP

The osteoporosis drug Reclast (zoledronic acid) raises the risk of kidney failure in patients with a history of or risk factors for renal impairment, according to a Drug Safety Communication issued by the Food & Drug Administration (FDA).    The agency said it had approved an update to the drug label for Reclast to better inform doctors and patients of this risk.

Reclast, which is administered via IV every one or two years, is part of a class of drugs called bisphosphonates.  It is approved to treat or prevent osteoporosis in women after menopause, and to increase bone mass in men who already have osteoporosis.  It is also approved to prevent osteoporosis in both men and women who take corticosteroid medications for at least one year.  Finally, Reclast is used to treat patients who have Paget's disease of the bone.

In March 2009, after five deaths from acute kidney failure were reported following Reclast infusion, the "Warnings and Precautions" section of the Reclast label was updated to include a recommendation to monitor serum creatinine before each dose of Reclast.  According to the FDA, reports of acute kidney failure continued to be made to the Adverse Event Reporting System (AERS) after the March 2009 label revision. A follow-up review in April 2011 showed an additional 11 cases of fatal acute kidney failure and nine cases of kidney injury requiring dialysis after Reclast infusion.

According to the FDA's Drug Safety Communication, the new Reclast label warns that the drug should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast, the agency said.

The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

These labeling changes are being made to the Reclast label only. Zoledronic acid is also sold as a treatment for cancer-related conditions under the brand name Zometa.  However, according to the FDA, kidney toxicity is already addressed in the Warnings and Precautions section of the Zometa label.

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