Reclast Gets FDA Kidney Failure Warning
By John Gever, Senior Editor, MedPage Today
Published: September 01, 2011
The osteoporosis drug zoledronic acid (Reclast) should not be used in patients with significant renal impairment, and physicians should screen patients for kidney dysfunction before starting them on the drug, the FDA said.
The agency ordered the new label warning for the drug after receiving 20 reports of acute kidney failure resulting in death or requiring dialysis.
The new warning indicates that patients with creatinine clearance of less than 35 mL/min or evidence of acute renal impairment should not be given zoledronic acid for osteoporosis.
It also identifies risk factors that physicians should take into consideration when prescribing the product. These include advanced age, concurrent treatment with other nephrotoxic drugs, and dehydration secondary to fever, sepsis, gastrointestinal losses, or diuretic therapy.
Zoledronic acid is also sold in a different formulation for cancer-related bone loss, under the name Zometa. The label for that product already includes warnings about renal toxicity and the risks in patients with impaired kidney function.
Previously, the Reclast label recommended serum creatinine measurement before each dose, normally given once a year, and noted that kidney failure is a risk.
That language was added in 2009 after the FDA learned of five deaths from acute kidney failure among patients taking the drug.
Since then, the agency said, it has received reports of 11 additional deaths and nine cases of kidney failure requiring dialysis, suggesting that the label warning needed to be strengthened.
The updated information also suggests that physicians measure creatinine clearance between Reclast doses in at-risk patients. The FDA recommends using a patient's actual body weight and the Cockcroft-Gault formula for calculating creatinine clearance.
By John Gever, Senior Editor, MedPage Today
Published: September 01, 2011
The osteoporosis drug zoledronic acid (Reclast) should not be used in patients with significant renal impairment, and physicians should screen patients for kidney dysfunction before starting them on the drug, the FDA said.
The agency ordered the new label warning for the drug after receiving 20 reports of acute kidney failure resulting in death or requiring dialysis.
The new warning indicates that patients with creatinine clearance of less than 35 mL/min or evidence of acute renal impairment should not be given zoledronic acid for osteoporosis.
It also identifies risk factors that physicians should take into consideration when prescribing the product. These include advanced age, concurrent treatment with other nephrotoxic drugs, and dehydration secondary to fever, sepsis, gastrointestinal losses, or diuretic therapy.
Zoledronic acid is also sold in a different formulation for cancer-related bone loss, under the name Zometa. The label for that product already includes warnings about renal toxicity and the risks in patients with impaired kidney function.
Previously, the Reclast label recommended serum creatinine measurement before each dose, normally given once a year, and noted that kidney failure is a risk.
That language was added in 2009 after the FDA learned of five deaths from acute kidney failure among patients taking the drug.
Since then, the agency said, it has received reports of 11 additional deaths and nine cases of kidney failure requiring dialysis, suggesting that the label warning needed to be strengthened.
The updated information also suggests that physicians measure creatinine clearance between Reclast doses in at-risk patients. The FDA recommends using a patient's actual body weight and the Cockcroft-Gault formula for calculating creatinine clearance.