The FDA announced that preliminary data from a safety trial demonstrate that, compared with allopurinol, febuxostat is linked to an increased risk for heart-related death. The FDA will examine the final results of the study once they are available, according to a press release.
The febuxostat label currently contains a warning and precaution regarding cardiovascular events.
Before FDA approval in 2009, data from clinical trials of febuxostat (Uloric, Takeda Pharmaceuticals) demonstrated a higher rate of myocardial infarction, stroke and heart-related death associated with the drug. Based on these findings, the FDA required an additional safety trial be conducted after approval and marketing.
The study, which ended recently, included more than 6,000 patients with gout who were treated with febuxostat or allopurinol. The main outcome was a combination of heart-related death, nondeadly MI, nondeadly stroke and a condition that causes inadequate blood supply to the heart requiring urgent surgery, according to the release.
Preliminary results demonstrated that febuxostat was associated with an increased risk for heart-related deaths and all-cause mortality when each outcome was evaluated separately. However, the drug did not increase the risk for combined events compared with allopurinol.
The FDA recommends health care professionals consider this information when prescribing or continuing patients on febuxostat. Adverse events should be reported using MedWatch, the FDA’s safety information and adverse events reporting program, at www.fda.gov/MedWatch/report.