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22-02-2019 | Rheumatology | News | Article

Regulatory update

FDA warns of increased death risk with febuxostat

medwireNews: The US FDA will update the prescribing information for the gout treatment febuxostat to include a boxed warning for death risk.

This warning follows an earlier safety communication, and is based on the results of an in-depth review concluding that febuxostat is associated with an increased risk for cardiovascular and all-cause mortality compared with allopurinol.

The FDA recommends that febuxostat should only be used to treat certain patients with an inadequate response or intolerance to allopurinol, and that patients who experience chest pain, shortness of breath, dizziness, altered heartbeat, numbness or weakness on one side of the body, speech problems, or sudden severe headache during febuxostat treatment should seek urgent medical attention.

The safety announcement also specifies that healthcare providers should discuss the cardiovascular risks of febuxostat with their patients and report any side effects to the FDA MedWatch program.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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