WebMD Medical News
Laura J. Martin, MD
Sept. 1, 2011 -- The FDA warns 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 are at heightened risk of kidney failure.
The FDA warning says that kidney failure is a rare but serious complication for at-risk patients taking Reclast. The drug was approved in April 2007.
Two dozen cases of kidney impairment or failure, including five deaths, were reported in a safety review published in January 2009. That led the FDA to recommend monitoring serum creatinine -- a measure of kidney health -- before each dose of the injected medication.
By April 2011, there were 11 more Reclast-related deaths due to kidney failure. Nine cases of kidney injury were also reported. Each required dialysis.
Reclast is manufactured by Novartis. It 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 administered 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 new warning tells doctors and patients the following:
The warning also offers the following advice to patients:
Zoledronic acid is also marketed under the name Zometa for the treatment of cancer-related bone damage. Zometa's label already contains warnings regarding kidney toxicity.
SOURCES:FDA web site: "FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)."National Library of Medicine: "Zoledronic Acid Injection."FDA web site: "Postmarket Reviews - Volume 2, Number 2, 2009."
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