FDA Warns Gout Drug May Increase Cardiovascular Death

The FDA recently issued a safety communication following the results of preliminary study that suggest patients with gout treated with febuxostat (Uloric) may be at an increased risk of heart-related mortality compared with allopurinol-treated patients, according to the statement.

When the drug was initially approved in 2009 to treat gout, the FDA required its manufacturer to conduct a safety clinical trial. When the final results are evaluated, the FDA plans to conduct a full review of the data and update the public, according to a press release.

Currently, febuxostat labeling includes a warning and precaution about cardiovascular events related to pre-approval clinical trials, which demonstrated an increased rate of heart problems in febuxostat-treated patients compared with those administered allopurinol.

Data from the original clinical trial suggested that febuxostat may increase the risk of heart attack, stroke, and cardiovascular-related mortality, which caused the FDA to require a post-approval safety study.

The safety study included more than 6000 patients with gout who were treated with febuxostat or allopurinol. The primary outcome was prevalence of cardiovascular-related death, non-fatal heart attack, non-fatal stroke, and restricted blood supply to the heart requiring surgery, according to the release.

Preliminary findings suggest that, febuxostat did not increase the risk of these combined events compared to allopurinol overall; however, when outcomes were evaluated separately, the investigators observed that febuxostat therapy increased the risk of cardiovascular-related death and all-cause mortality, according to the FDA.

The FDA requests that adverse events be reported and urges healthcare providers to consider these findings when prescribing gout treatment or continuing patients on febuxostat.