This was successfully posted to your pofile.
This box will close automatically in a few seconds. Close this window
We don't have an e-mail address on file for you. To use AAFP Connection, you must have an e-mail address in our records. Click Here
Renal Injury Prompts Label Changes for Osteoporosis Drug
Reclast Linked to Acute Renal Failure, Deaths in At-risk Patients
By News Staff
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 program.