Reactions 1680, p2 - 2 Dec 2017 Higher risk of deaths with febuxostat vs allopurinol Preliminary clinical trial results show that the gout medicine febuxostat (Uloric) is linked with a greater risk of heart-related deaths and all-cause deaths versus allopurinol, says the US FDA. In a safety announcement from the FDA, it was noted that the manufacturer of Uloric (Takeda Pharmaceuticals) was asked in 2009 to conduct an additional safety clinical trial of this product. The febuxostat drug labels already carry warnings about cardiovascular (CV) events after preregistration clinical trials showed an increased rate of such heart- related problems (e.g. heart attacks, stroke, and heart- related deaths) in patients treated with febuxostat, compared with allopurinol (i.e. another gout medicine). The additional safety clinical trial of febuxostat requested by the FDA was conducted in >6000 patients with gout, and "the primary outcome was a combination of heart-related death, non-deadly heart attack, non- deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery", stated the FDA. Preliminary results from this trial showed that while febuxostat did not increase the overall risk of these combined CV-related events versus allopurinol, febuxostat was associated with an increased risk of heart-related deaths and all-cause deaths. The FDA will continue to evaluate this safety issue and plans to conduct a comprehensive review once the agency receives the final trial data from the manufacturer. The FDA will advise the public once it has more information. In the meantime, healthcare professionals are advised to consider this safety information when they consider prescribing febuxostat to their patients. In addition, patients taking febuxostat should ask their doctor if they have any concerns, but they should not stop taking the drug without first consulting their doctor. US Food and Drug Administration. FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric). Internet Document : 15 Nov 2017. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm584702.htm 803285960 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680
Reactions Weekly – Springer Journals
Published: Dec 2, 2017
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