FDA Issues New Warning for Reclast (Zoledronic Acid)

Prescription DrugsIn September 2011, the US Food and Drug Administration (FDA) issued a new warning label for the osteoporosis drug zoledronic acid, which is marketed as Reclast.  The FDA indicates that the medication shouldn’t be used for patients who have significant renal impairment; they also state that before starting patients on Reclast, physicians should screen them for kidney dysfunction.

There have been cases of acute renal failure—necessitating dialysis or having a fatal outcome—that have been reported to the FDA.  That is why the FDA undertook this new warning label effort.  In patients with a history of (or with risk factors of) kidney impairment, kidney failure is a rare but serious condition associated with Reclast.

Physicians should be aware of the following risk factors for developing renal failure:

  • Underlying moderate to severe renal impairment
  • Use of nephrotoxic or diuretic medications (at the same time as Reclast)
  • Severe dehydration before or after Reclast is used

Additionally, it should be noted that in patients with underlying kidney impairment, the risk of developing renal failure increases with age.

On the new warning label for Reclast, there will be updated instructions for prescribing and patient monitoring.  The FDA says that the medications is contraindicated in patients with creatinine clearance less than 35 mL/min; it’s also contraindicated for patients with evidence of acute renal impairment.

The label also suggests that patients be screened before being given Reclast; this is to identify at-risk patients.  Finally, patients receiving Reclast should have their renal function monitored.

Updated on: 01/27/16
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