Reclast Linked To Kidney Failure

Reclast, a drug given intravenously to prevent or treat osteoporosis, has been reported to cause kidney failure requiring dialysis or resulting in death. The U.S. Food and Drug Administration (FDA) has approved an update to the drug label and medication guide to better inform healthcare professionals and patients of the risk of kidney (renal) failure.

These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment.

Reclast, marketed under the brand name Aclasta outside the United States, is used for several bone-related conditions, including to treat or prevent osteoporosis in women after menopause, reduce the chance of having a hip or spinal fracture, increase bone mass in men with osteoporosis, treat or prevent osteoporosis in those who take corticosteroid medications for at least one year, and treat Paget’s disease of the bone.

Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

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