Brilinta Approved for Acute Coronary Syndromes2011-Jul-21
By -- Scott Roberts
THURSDAY, July 21 (HealthDay News) -- Brilinta (ticagrelor) has been approved by the U.S. Food and Drug Administration to help reduce the risk of heart attack and cardiovascular death among people with acute coronary syndromes (ACS).
ACS is an umbrella term for any condition caused by reduced blood flow to the heart, such as unstable angina or heart attack. Blood-thinning Brilinta helps prevent clots that could impede cardiovascular blood flow, the FDA said in a news release.
The drug was studied in tandem with aspirin use. However, Brilinta's label will warn that its effectiveness will be impaired if people take aspirin in doses higher than 100 mg. per day, the FDA said.
The boxed label warning also specifies that Brilinta could lead to significant, possibly fatal, bleeding, a common label warning for blood-thinning drugs, the agency said.
As a condition of approval, drug maker AstraZeneca must take steps to alert doctors of the risk of using higher doses of aspirin.
The FDA has more about this approval.
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