FDA warns of increased risk of death associated with febuxostat

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

This warning follows a previous safety communication and is based on the results of a thorough review concluding that febuxostat is badociated with an increased risk of cardiovascular and all-cause mortality compared with allopurinol.

The FDA recommends that febuxostat be used only in certain patients with an inadequate response or intolerance to allopurinol, and that patients with chest pain, shortness of breath, febuxostat should do so. subject to a medical emergency.

The safety announcement also states that health care providers should discuss the cardiovascular risks of febuxostat with their patients and report any adverse events to the FDA's Medwatch program.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare, a member of the Springer Nature Group

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