A new study has found that febuxostat, a gout drug that has been in use for nearly a decade, can increase the risk of death in certain patients.
The study, presented by the American College of Cardiology, showed a rising risk of fatal cardiovascular events in patients with pre-existing heart issues who had been taking the drug for two years or longer, calling into question the safety of its long-term use.
Febuxostat was approved by the FDA in 2009 as a replacement for an older treatment, allopurinol, which had been in use since the 1960s and was linked to kidney problems and severe allergic reactions.
The long-term study of febuxostat included 6,190 patients and found that the risk of death from cardiovascular disease was 34 percent higher than the risk with allopurinol. In general, the risk of death from any cause was 22 percent higher in patients taking febuxostat.
“The results are entirely unexpected and we don’t have a mechanistic explanation for them,” the study’s chief author, Dr. William White of the University of Connecticut School of Medicine, said.
The study’s authors said that they hope other ongoing trials in Europe will better determine the safety risks of febuxostat in patients with pre-existing cardiovascular issues versus those without cardiovascular disease.
About 8 million Americans suffer from gout, a form of arthritis that causes severe pain in the big toe and other joints.
Read the full report.