Drug Safety Alerts

Febuxostat: Increase Risk of Death!

Febuxostat is indicated for Gout, FDA has added a boxed warning for Febuxostat indicating an increased risk of death compared to its alternative allopurinol. This conclusion was based on an 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 advised that the use of febuxostat should be reserved for patients who have failed or do not tolerate allopurinol. Patients should be informed about cardiovascular risks with febuxostat and should be advised to seek immediate medical attention if they experience symptoms such as; chest pain, shortness of breath, rapid or irregular heartbeat, numbness or weakness on one side of the body, dizziness, trouble talking, and sudden severe headache.

All Healthcare Professionals are advised to monitor patients taking Febuxostat, and caution should be observed in Patients already suffering from Cardiovascular diseases. In case such event is observed, please report to PDCU through; mss.punjab.gov.pk/


Drug Safety Alerts,

Provincial Drug Control Unit,

Primary & Secondary Healthcare Department,

Govt. of the Punjab