Pharmacy Services Alerts
Limbrel May Cause Drug-Induced Liver Injury and Hypersensitivity Pneumonitis
Dec 4, 2017 8:27 AM
Febuxostat was associated with an increased risk of cardiovascular and all-cause mortality, according to preliminary results from a safety clinical trial. In the safety trial, over 6,000 patients over the age of 50 with gout and a history of either cardiovascular or cerebrovascular disease were randomized to feboxustat or allopurinol once daily. The trial examined a composite primary endpoint consisting of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring urgent coronary revascularization. There was no significant difference between febuxostat and allopurinol for the composite endpoint, but further analysis revealed that cardiovascular and all-cause mortality were significantly increased in patients taking febuxostat.
Febuxostat is manufactured by Takeda Pharmaceuticals and is FDA-approved to treat gout. Febuxostat labeling already has a Warning and Precaution about cardiovascular events. In the clinical trials that led to FDA-approval, febuxostat demonstrated an increased risk of cardiovascular events when compared to allopurinol. For this reason, the FDA requested that Takeda Pharmaceuticals conduct the aforementioned safety clinical trial to look at cardiovascular events more closely. The FDA is currently awaiting final results from the safety study so they can perform a thorough review of the findings. Any new updates from the FDA will be communicated to the public. In the meantime, clinicians are urged to consider this safety information when prescribing febuxostat. Patients should discuss any concerns with a health care professional.
More information is available at the following links:
- FDA Medwatch Alert – November 15, 2017
- FDA Safety Alert – November 15, 2017