Warnings and Precautions Updated for Brilinta

The label update is based on post-marketing reports of bradyarrhythmias
The label update is based on post-marketing reports of bradyarrhythmias

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Brilinta (ticagrelor; AstraZeneca) for an addition to the label under the Warnings and Precautions concerning bradyarrhythmias, based on post-marketing reports.

Specifically, the label addition states:

Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the post-marketing setting. Patients with a history of sick sinus syndrome, 2nd or 3rd degree AV block or bradycardia-related syncope not protected by a pacemaker were excluded from PLATO and PEGASUS and may be at increased risk of developing bradyarrhythmias with ticagrelor.

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Brilinta, a P2Y12 platelet inhibitor, is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or history of MI. It is also indicated to reduce the rate of stent thrombosis in patients who have been stented for ACS.

For more information visit FDA.gov.

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