Brilinta (tricagrelor): New Blood-Thinning Drug Approved

New Drugs , News / September 21, 2016

The blood-thinning drug Brilinta (tricagrelor) was approved by the FDA for the reduction of cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).ACS includes a group of symptoms for any condition, including unstable angina or heart attack, that could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of additional cardiovascular events.

Brilinta has been studied in combination with aspirin. A boxed warning warns that aspirin doss above 100 mg/day decreases the effectiveness of Brilinta.

In clinical trials, Brilinta was found to be more effective than Plavix in preventing heart attacks and death, though that was only seen with aspirin maintenance doses of 75 to 100 mg once daily.

The boxed warning also states that, like other blood-thinning agents, Brilinta increases the rate of bleeding and can cause significant, sometimes even fata, bleeding. The most common adverse reactions reported by people taking Brilinta in clinical trials were bleeding and difficulty breathing (dyspnea).

Brilinta was approved with a Risk Evaluation and Mitigation Strategy, a plan to help ensure that the drug’s benefits outweigh its risks. As part of that plan, the manufacturer must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, Brilinta will be dispensed with a Medication Guide that informs patients of the most important information about the medication.

Brilinta is made by AstraZeneca of Wilmington, Del.

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