FDA Approves Updated Safety Labeling Changes for Bivalirudin

April 15, 2016—The US Food and Drug Administration (FDA) issued safety labeling changes for bivalirudin (Angiomax, The Medicines Company) that were approved by the FDA Center for Drug Evaluation and Research (CDER). The updated label information includes new warning, precaution, and adverse reaction notices. Angiomax, bivalirudin lyophilized powder for injection/intravenous use, received initial FDA approval in 2000.

The updated label warns that acute stent thrombosis (AST, < 4 hours) has been observed at a greater frequency in Angiomax-treated patients (1.2%; 36/2889) compared to heparin-treated patients (0.2%; 6/2911) with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). Among patients who experienced an AST, one fatality (0.03%) occurred in an Angiomax-treated patient and one fatality (0.03%) in a heparin-treated patient.

The warning advises that Angiomax-treated patients managed by target vessel revascularization should remain in a facility capable of managing ischemic complications for at least 24 hours and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.

Additionally, the label warns about laboratory test interference. Angiomax affects International Normalized Ratio (INR). Therefore, INR measurements made in patients who have been treated with Angiomax may not be useful for determining the appropriate dose of warfarin.

Adverse reactions observed in postmarketing experience include pulmonary hemorrhage, cardiac tamponade, and increased INR, advised the updated FDA CDER-approved label for Angiomax.