Recently, a clinical trial conducted on the safety of febuxostat reported an increased risk of cardiovascular-related death with febuxostat as compared with allopurinol. The febuxostat drug label already includes a warning about the heart-related problems because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. Febuxostat is approved by FDA for the treatment of gout in adults. Gout leads to building up of uric acid in joints further causing sudden attacks of redness, swelling, and pain in one or more joints.
Febuxostat generally acts by lowering uric acid levels in the blood. At the time of FDA approval, the clinical trial conducted reported problems such as heart attacks, strokes, and other heart-related deaths. Thus, FDA required an additional safety clinical trial after the drug…
