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(www.fda.gov). 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:
- Reclast is contraindicated in patients with creatinine clearance less than 35 mL/minute or in patients with evidence of acute renal impairment.
- Calculate creatinine clearance before each dose of Reclast. Interim monitoring of creatinine clearance should be performed after Reclast dosing in at-risk patients. Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula.
- Screen patients before each infusion of Reclast to identify those with underlying acute or chronic renal impairment, advanced age or dehydration. Patients with underlying renal impairment appear to be at highest risk for kidney failure, and the drug should be used with caution in this population.
- The risk of acute renal failure may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy or other causes. The risk of developing renal failure in patients with renal impairment also increases with age.
- Report adverse events associated with Reclast to the FDA's MedWatch(www.accessdata.fda.gov) program.