US Food & Drug Administration (FDA) has concluded there is an increased risk of death with Febuxostat compared to another gout medicine, Allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Febuxostat.
FDA recommends that Febuxostat should be reserved for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Febuxostat and advise them to seek medical attention immediately if they experience any of the following symptoms:
- Chest pain
- Shortness of breath
- Rapid or irregular heartbeat
- Numbness or weakness on one side of your body
- Dizziness
- Trouble talking
- Sudden severe headache
Febuxostat monograph in EMDEX has been updated to reflect this important safety information. See Febuxostat (under Pharmacovigilance).