The FDA has initiated an additional warning for Reclast® on September 1, 2011 for renal failure and kidney impairment; and warns that patients with kidney dysfunction should not use this drug.
Reclast's (zoledronic acid) label was originally changed in 2009, recommending creatinine clearance testing prior to administration, with a result of no less than 35 mL/min to screen out those with kidney impairment. This 2009 Reclast labeling change came as a result of five reports of kidney failure resulting in death. Reclast is used to treat both postmenopausal osteoporosis and for patients with cancer-related bone loss. The form of zoledronic acid, given to cancer patients is Zometa®, a stronger dose of this drug.
Today's change, by the FDA, came as a result of an additional 20 reports due to acute kidney failure or patients requiring dialysis from Reclast administration. Of these 20 reports, 11 resulted in death and 9 patients where put on dialysis, due to kidney failure. Due to these additional deaths from Reclast, the FDA decided to include a stronger warning on the drugs label to alert physicians of this dramatic side effect so their patients would be alerted to this outcome from administration in those with histories of kidney problems.
According to the FDA, "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. 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. (MedPage Today, September 1, 2011)"
This drug is also included in an upcoming FDA Drug Safety and Risk Management Advisory Committee on September 9, 2011 in Silver Springs Maryland from 8:00 a.m. to 4:30 p.m., the phone contact is: 301-796-9001. This committee meeting will be focusing on all bisphosphonates, including Reclast.
Now the doctors and infusion centers need to follow through and notify their patients of these important warnings, before they receive Reclast.
For more information on today's updated label warning see the FDA's press release on Reclast and Kidney Impairment.
- Reclast Gets FDA Kidney Failure Warning, By: John Gever, Senior Editor, MedPage Today Published: September 01, 2011 http://www.medpagetoday.com/ProductAlert/Prescriptions/28320
- FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid) http://www.fda.gov/Drugs/DrugSafety/ucm270199.htm