FDA Approves Blood Dilution Drug Brilinta for Acute Coronary Syndrome

On July 20, the US Food and Drug Administration (FDA) approved the blood dilution drug BRILINTA (Ticagre) to reduce cardiovascular death and heart attack in patients with acute coronary syndrome (ACS).

ACS includes a variety of diseases that cause a range of symptoms, such as unstable angina or heart attack, which can be caused by a decrease in blood flow to the heart. Brilinta helps to reduce the risk of additional cardiovascular events by preventing the formation of new blood clots, thereby keeping the blood flowing in the body.

A combination of Brilinta and aspirin has been studied. A black box warning for health care professionals and patients warns that aspirin doses higher than 100 mg/d can reduce the effectiveness of the drug.

Dr. Norman Stockbridge, director of Cardiovascular and Kidney Products Division, FDA Center for Drug Evaluation and Research, said that in clinical trials, BRILINTA is more effective than clopidogrel in the prevention of heart attacks and deaths, but this benefit is only sustained by aspirin. Dosage is 75-100mg/d only to see.

The black box warning also states that, like other blood thinners, Brilinta can increase the incidence of bleeding and can cause significant and sometimes fatal bleeding. The most common adverse reactions reported by patients taking BRILINTA in clinical trials were bleeding and dyspnea (wheeze).

When BRILINTA is approved, it requires a risk assessment and mitigation strategy, a plan that helps ensure that the benefits of drugs outweigh the risks. As part of the plan, the company must educate doctors to remind them of the risk of using higher doses of aspirin. In addition, Brilinta will also use drug guides to inform patients about the most important medication information. The guide will be distributed to each patient each time a prescription is issued.

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