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.