After learning of five deaths from acute kidney failure in 2009 and receiving reports of 11 additional deaths and nine cases of kidney failure which resulted in dialysis treatment, the FDA recently suggested that the manufacturers of the osteoporosis treatment drug, Reclast, strengthen its warning.

Reclast is a biphosphonate drug like Fosamax, Actonel and Boniva, designed to help increase bone density and strength. The difference between Reclast and its competitors is that it is administered intravenously only once a year. The FDA’s new warning suggests that Reclast should not be used in patients with significant renal impairment and that physicians should screen patients for kidney dysfunction before prescribing the drug. In addition to screening, physicians should also measure creatinine clearance between Reclast doses in at-risk patients.

Risk factors that should be considered prior to prescribing Reclast include advanced age, concurrent treatment with other kidney-damaging drugs, and dehydration secondary to fever, sepsis, gastrointestinal losses, or diuretic therapy. The generic form of Reclast, zoledronic acid, is also sold in a different formulation under the brand name Zometa. However, Zometa already carries warnings about renal toxicity in patients with impaired kidney function. If you need more information on this subject, contact Danielle Mason, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.

Source: FDA