Renal Injury Prompts Label Changes for Osteoporosis Drug

The drug label for the zoledronic acid product marketed as Reclast has been updated after the osteoporosis medication was linked to 16 deaths from acute renal failure, the FDA said in a Sept. 1 safety announcement. The agency also reported nine cases of renal injury requiring dialysis after Reclast infusions.

The FDA said rare cases of renal failure have been reported in patients taking Reclast who had a history of or risk factors for renal impairment, including concomitant use of nephrotoxic or diuretic medications or severe dehydration occurring before or after Reclast was given.

The risk of developing renal failure in patients with underlying renal impairment also increases with age, the FDA said.

The agency said no labeling changes are being required for the zoledronic acid product marketed as Zometa, which is approved for treatment of cancer-related indications and which already provides dose-reduction information for patients with renal impairment and addresses renal toxicity in the warnings and precautions section of its label.

Reclast is given as an intravenous infusion in a single dose once every one to two years to treat or prevent osteoporosis in women after menopause, increase bone mass in men with osteoporosis, treat or prevent osteoporosis in men or women who take corticosteroid medications for at least one year, or treat men and women who have Paget's disease of bone.

The FDA issued the following information for physicians: