This label change came about because cases of acute renal failure (requiring dialysis or having a fatal outcome) have been reported to the FDA.
Kidney failure is a rare—but serious—condition associated with using Reclast in patients with a history of or with risk factors of kidney impairment. Physicians should take note of these risk factors for developing renal failure when on Reclast:
Severe dehydration before or after Reclast is used
Underlying moderate to severe kidney impairment
Use of nephrotoxic or diuretic medications at the same time as Reclast
Also, for patient with underlying renal impairment, the risk of developing renal failure increases with age.
The new warning label for Reclast includes updated instructions for prescribing, as well as for patient monitoring. Reclast is contraindicated in patients with creativine clearance less than 35 mL/min and in patient with evidence of acute renal impairment.
Before prescribing Reclast, physicians should screen the patient to identify if he/she is at risk of developing renal impairment. Additionally, the new label says that patient on Reclast should be monitored for renal function.