The Food and Drug Administration (FDA) has announced that preliminary results of a clinical safety trial show an increased risk of heart-related deaths in patients using febuxostat (Uloric), a drug approved in 2009 to treat gout, compared with those using allopurinol (Aloprim, Zyloprim), the standard gout treatment. Febuxostat lowers the blood level of uric acid, which, when elevated, causes the inflammation and pain of a gout attack. The FDA required the manufacturer of febuxostat to conduct a clinical safety trial after the drug's 2009 approval.

Clinical trials during drug development had previously indicated an increased risk of heart-related problems in patients receiving febuxostat compared with those receiving allopurinol. As a result, febuxostat's label carries a warning and a precaution regarding cardiovascular events. In the current safety trial, over 6,000 patients were treated with either febuxostat or allopurinol. The FDA reports that the primary outcome of the study was "a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery."

The preliminary findings indicate no increased risk of this combined outcome with febuxostat. However, when the outcomes were evaluated separately, febuxostat appeared to increase the risk of heart-related deaths and deaths from all causes compared with allopurinol.

Once the final study data are submitted to the FDA and evaluated, the agency may issue new warnings or take further action. At this time, NPs who work with patients prescribed febuxostat should consider each patient's risk-to-benefit ratio when determining if the patient should remain on febuxostat. Nurses and NPs should report any notable adverse effects of febuxostat to the FDA MedWatch program at http://www.fda.gov/medwatch/report.htm.

To read the FDA Drug Safety Communication regarding febuxostat, go to http://www.fda.gov/downloads/Drugs/DrugSafety/UCM584803.pdf.