Product Liability

Osteoporosis drug gets severe kidney impairment warning

The Food and Drug Administration (FDA) is requiring that the safety label for the osteoporosis treatment Reclast (zoledronic acid injection) include an updated warning about a potentially deadly kidney impairment possibly associated with Reclast use. Reclast is in a class of medications known as bisphosphonates. The new warning was required after the FDA received reports of acute renal failure requiring dialysis or causing death following Reclast treatment.

The label was revised to include a contraindication for patients with creatinine clearance less than 35 mL/min or in patients with evidence of renal impairment. The label also requires that doctors screen patients prior to administering Reclast in order to identify at-risk patients.

Risk factors for developing renal failure include underlying moderate to severe renal impairment, and use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast. Underlying renal impairment also increases with age.

The label changes are being made to the Reclast label only, although the drug’s active ingredient, zoledronic acid, also sold under the brand name Zometa, is approved for the treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of  Zometa as well as on the Reclast labels. Dose reductions for Zometa are provided for patients with renal impairment.

This is not the first warning the FDA has issued on osteoporosis treatments. Last year, the FDA announced that it was looking into data that suggested that bisphosphonates, such as Fosamax, Actonel, Boniva and Reclast, put users at greater risk for bone fracture. Fosamax already carries a warning for osteonecrosis of the jaw, or ONJ, a bone decay in the jawbone, and has been linked to possible thigh fractures.

Any side effects with Reclast or any other drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA
Beasley Allen Fosamax