Skip Navigation LinksHome > November 2011 - Volume 111 - Issue 11 > Safety Concerns Over an Osteoporosis Drug
AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000407287.40125.eb
Drug Watch

Safety Concerns Over an Osteoporosis Drug

Aschenbrenner, Diane S. MS, RN

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Author Information

Diane S. Aschenbrenner is the course coordinator for undergraduate pharmacology at Johns Hopkins University School of Nursing in Baltimore, MD. She also coordinates Drug Watch: dianea@son.jhmi.edu.

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Abstract

* The label for the osteoporosis drug Reclast has been revised to strengthen the warning concerning the risk of acute renal failure, a rare adverse effect.

* Prior to administering the drug, nurses should assess patients for risk factors for acute renal failure: decreased creatinine clearance, older age, and dehydration.

The Food and Drug Administration (FDA) has further revised the label of Reclast, a form of zoledronic acid used to treat or prevent osteoporosis, in an attempt to better inform prescribers of the risk of a rare complication, kidney failure. (Renal toxicity is already addressed in the warnings-and-precautions section of the label of another form of zoledronic acid, sold under the trade name of Zometa, which is used for cancer-related indications.) Reclast is given as an IV infusion once every one to two years. Although the FDA had revised the label of Reclast in March 2009 to warn of acute renal failure and recommend assessment of the serum creatinine level before each dose was administered, cases of acute renal failure continue to be reported.

The new label revisions emphasize the importance of assessing creatinine clearance before drug administration (the drug is contraindicated if the creatinine clearance is lower than 35 mL per minute or if there are indications of acute renal failure), as well as assessment after Reclast dosing in patients at high risk for acute renal failure. The following risk factors for acute renal failure are now noted on the label: underlying acute or chronic renal impairment, advanced age, and dehydration (secondary to conditions such as fever, sepsis, gastrointestinal losses, or diuretic therapy). Prior to administering Reclast, nurses should carefully assess patients for these risk factors and consult the prescriber (if someone else) if they're noted. Adverse events associated with Reclast use should be reported to the FDA's MedWatch program at http://1.usa.gov/lBeKg. To read the FDA Drug Safety Communication regarding Reclast, go to http://1.usa.gov/oODqLi.

© 2011 Lippincott Williams & Wilkins, Inc.

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