TREATMENT FOR GOUT LINKED WITH AN INCREASED RISK OF DEATH
By David C. Harman, Burg Simpson Shareholder
The Federal Drug Administration (FDA) recently released a Safety Announcement to warn of an increased risk of death associated with the use of a gout medication called Uloric (febuxostat). Following an in-depth analysis of clinical trial data, the FDA found “[i]n patients treated with Uloric, 15 deaths from heart-related causes were observed for every 1,000 patients treated for a year compared to 11 deaths from heart-related causes per 1,000 patients treated with allopurinol for a year….there were 26 deaths from any cause per 1,000 patients treated for a year with Uloric compared to 22 deaths per 1,000 patients treated for a year with allopurinol.” In conclusion, the FDA found that the use of Uloric increased the risk of heart-related death and death from all causes when compared to allopurinol, another gout medication.
A Black Box Warning is being added to Uloric prescribing information to warn of the increased risk of heart-related death and death from all causes. In addition, the FDA is limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe adverse events with allopurinol.
If you or a loved one have suffered a heart-related injury or death while taking Uloric, contact one of the experienced defective drug attorneys at Burg Simpson today to discuss your legal rights. Call us at 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.