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    AstraZeneca Issues Warning for BRILINTA's Risk of Increased Bleeding

    August 10, 2011

    AstraZeneca has issued a drug warning letter informing physicians of important safety information for BRILINTA (ticagrelor), a P2Y12 platelet inhibitor recently approved by the FDA.

    The safety concerns center on:

    • Risk of increased bleeding
      • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding.
      • Do not use BRILINTA in patients with active bleeding or history of intracranial hemorrhage.
      • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.

     

    • Decreased efficacy with BRILINTA (ticagrelor) in combination with aspirin doses exceeding 100 mg ´╗┐
      • BRILINTA has been studied in combination with aspirin. Use with aspirin maintenance dose of 75-100 mg once daily.
      • Higher aspirin doses (above 100 mg) appear to decrease the efficacy of BRILINTA.

    Read the Letter Issued by AstraZeneca