Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) is urging physicians to monitor patients following injections of Reclast (zoledronic acid) following reports of acute renal failure associated with the use of Reclast, according to the Postmarket Reviews section of the Volume 2, Number 2 2, 2009 issue of its quarterly online newsletter, Drug Safety News (DSN).

Reclast is an FDA-approved bisphosphonate administered once-yearly by intravenous infusion for the treatment of osteoporosis in postmenopausal women and men, Paget’s disease of the bone, and prevention and treatment of glucocorticoid-induced osteoporosis in patients expected to be on glucocoticoids for at least one year.

From April 2007 through February 17, 2009, the FDA’s Adverse Event Reporting System (AERS) received 24 cases of renal impairment and some cases of acute renal failure associated with the use of Reclast. Reclast’s labeling indicates that the medication is not recommended for use in patients with severe renal impairment. While some cases reported to the FDA noted underlying medical conditions and/or concomitant medications, there were cases in which the FDA says it was possible to establish a reasonable association between Reclast and the adverse event.

According to the data, many patients improved following intravenous fluid administration or other supportive care. Three patients required hemodialysis during hospitalization. Seven deaths were reported. In the cases of death, four were reported as acute renal failure. These patients also reported underlying medical conditions, concomitant medications or lack of information making any association between Reclast use and death due to acute renal failure difficult to establish.

The FDA is urging physicians to monitor serum creatinine in patients with pre-existing renal compromise or other risk factors, including concomitant nephrotoxic medications or diuretic therapy, or severe hydration, before and after each infusion.

As a result of the postmarketing reports, Reclast manufacturer has updated Warnings and Precautions, Post-Marketing Experience, and Drug Interactions sections of the drug’s label to include information about acute renal failure.

Source: FDA

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