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Osteoporosis Drug Reclast Increases Risk for Kidney Failure

The FDA has issued a warning that the osteoporosis drug Reclast (zoledronic acid) raises the risk of kidney failure.

The warning is targeted at patients who already suffer from kidney impairment. It's also aimed at those who are taking potentially kidney-damaging (nephrotoxic) medications or diuretics at the same time as Reclast.

According to the new warning, Reclast-induced kidney failure can also occur among severely dehydrated patients. Older patients with kidney impairment, such as those in nursing homes, are at heightened risk of kidney failure.

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.

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.

Reclast is prescribed to treat or prevent osteoporosis among postmenopausal women. In those women the drug reduces the risk of hip and spinal fractures.

Reclast is used in infusions every one to two years. It may be used to bolster bone mass in men with osteoporosis. The drug is prescribed for men and women who take corticosteroid drugs for at least one year to prevent osteoporosis. It is also prescribed for people with a bone-weakening condition known as Paget's disease of bone.

The revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring.

The new warning tells healthcare professionals the following:

• Do not prescribe Reclast to patients with creatinine clearance less than 35 mL/min or to those with evidence of acute kidney impairment
• Continue to screen patients prior to each administration 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. Reclast 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, etc. The risk of developing renal failure in patients with renal impairment also increases with age.
• 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.

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.

The updated warning tells patients the following:

• Kidney failure is a rare, but serious, side effect associated with the use of Reclast.
• Your healthcare professional will order a serum creatinine level (a blood test) before and after each dose of Reclast to assess how well your kidneys are functioning.
• If you have kidney disease, discuss the necessity of Reclast treatment with your healthcare professional. There may be other treatment choices available to you.
• Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location where it is easily retrieved.

For more on medical safety issues, see the library of articles by Daytona Beach nursing home injury attorney.




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