FDA approves Brilinta to reduce cardiovascular death and heart attack in ACS patients

Boxed warning says daily aspirin doses above 100 milligrams decrease effectiveness

The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).

ACS includes a group of symptoms for any condition, such as 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 another cardiovascular event.

Brilinta has been studied in combination with aspirin. A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication.  

"In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

The boxed warning also says that, like other blood-thinning agents, Brilinta increases the rate of bleeding and can cause significant, sometimes fatal, 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 company 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. The guide will be distributed each time a patient fills their prescription.