Black box warning for bleeding risks added to antiplatelet Brilinta

blood cells Black box warning for bleeding risks added to antiplatelet BrilintaThe safety label for the oral antiplatelet drug Brilinta (ticagrelor) has been updated to include a new boxed warning for serious bleeding risks and a lessening of effectiveness when taken with maintenance doses of aspirin above 100 mg.

Brilinta, made by AstraZeneca, is used with low-dose aspirin to help prevent heart attacks and stokes in people with heart problems such as unstable angina or previous heart attack, as well as in patients with acute coronary syndrome (ACS). It is also used to reduce the risk of stent thrombosis in patients who have been stented for the treatment of ACS.

Like other blood thinners and antiplatelets, Brilinta can increase the risk of dangerous and even fatal bleeding in some people. The new black box warning advises against the use of Brilinta in patients who have an existing bleeding problem or a history of brain hemorrhage, liver problems, stomach ulcers, intestinal polyps, or other conditions that increase internal bleeding.

The warning also advises, if possible, to manage bleeding associated with the drug without discontinuing the medication, as stopping Brilinta increases the risk of subsequent cardiovascular events.

Brilinta also carries a new black box warning about the use of aspirin with Brilinta. While aspirin is often combined with the antiplatelet, taking too much aspirin (more than 100 mg a day) may reduce Brilinta’s effectiveness.

Black boxed warnings, or boxed warnings, are the strongest Food and Drug Administration (FDA) warnings and involve products where there is a reasonable probability that use of the drug may cause serious health consequences or death.

Source: FDA