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Acute stent thrombosis warning strengthened on US bivalirudin label
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The FDA recently approved changes to the labeling of bivalirudin, including the strengthening of safety information about acute stent thrombosis seen in patients with STEMI assigned the direct thrombin inhibitor during PCI.
In a letter from the FDA dated March 21 to The Medicines Company, manufacturer of bivalirudin (Angiomax), the agency wrote that the company’s supplemental new drug application, which revised several sections of bivalirudin’s label in the United States, was approved, including “an important update to the safety information regarding risk of acute stent thrombosis (AST) in patients with [STEMI] undergoing PCI.”
A passage from the warnings and precautions section of the new label, released to the public April 16, reads: “AST (< 4 hours) has been observed in a greater frequency in Angiomax-treated patients (1.2%, 36/2,889) compared to heparin-treated patients (0.2%, 6/2,911) with STEMI undergoing primary 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. These patients have been managed by target vessel revascularization. Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.”
In an additional measure, the dosage and administration section of the label was revised to indicate that in patients with STEMI, “continuation of the Angiomax infusion at a rate of 1.75 mg/kg/h following PCI/[angioplasty] for up to 4 hours postprocedure should be considered to mitigate risk of stent thrombosis.”
Also in the warnings and precautions section of the label, a passage was revised to indicate that because the drug affects INR, measurements of INR may not be accurate in patients assigned warfarin who were administered bivalirudin.
References:
FDA. Approval Letter, Supplement 036, NDA 020873. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020873Orig1s036ltr.pdf. Accessed April 19, 2016.
FDA. Highlights of Prescribing Information: Angiomax. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020873s036lbl.pdf. Accessed April 19, 2016.