The drug is for treatment of acute coronary syndromes, a group of cardiovascular symptoms that include unstable angina or heart attack from reduced blood flow to the heart.
"Talk to your doctor or pharmacist about Brilinta if you take blood thinners."
Brilinta, which is manufactured by AstraZeneca, prevents the formation of new blood clots, which help reduce the risk of heart events. It carries warnings that high doses of aspirin above 100 milligrams per day can reduce its effectiveness.
Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said the medication was most effective with daily aspirin doses between 75 and 100 milligrams in clinical trials.
A warning to be included on the box notes that similar to other blood thinning medications, the drug increases the rate of bleeding, which can be significant and sometimes fatal. Bleeding and difficulty breathing were the most commonly reported side effects in clinical trials.
Brilinta was approved with a Risk Evaluation and Mitigation Strategy to ensure that its benefits outweigh the risks. As part of that plan the drug manufacturer must conduct educational outreach with doctors about the risks of using high-dose aspirin with the drug. It also will be dispensed with a medication guide, which will also be handed out each time it is refilled.
Though approved in Europe last year, approval of Brilinta in the United States has been a rocky road. A year ago the drug received a favorable review from an FDA advisory committee, but in mid-December 2010, FDA officials declined to approve the drug, citing a need for additional analysis of the large-scale PLATO study funded by AstraZeneca.
The PLATO trial evaluated the safety and efficacy of Brilinta against market competitor clopidogrel (Plavix) in a study of more than 18,000 patients. However there were questions about interpreting study results because there was no benefit seen in the 1,400 Americans included in the study.
Last month at an American Heart Association presentation, Dr. Kenneth W. Mahaffey, author of the PLATO research and co-director of cardiovascular research at the Duke Clinical Research Institute, said that patients who took Brilinta combined with low-dose aspirin were 16 percent less likely to have a heart attack, stroke or die within one year than those taking Plavix. Addressing the lack of benefit for Americans in the PLATO study, he noted that high-dose aspirin is more frequently used in the United States.
"In the PLATO trial ticagrelor reduced the incidence of cardiovascular death," he said.