Warning says daily aspirin doses above 100 milligrams decrease effectiveness.

FDA approved AstraZeneca’s blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). It works by preventing the formation of new blood clots, thus maintaining blood flow in the body.

Brilinta has been studied in combination with aspirin. A boxed warning to healthcare 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,” points out 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 notes 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 the drug in clinical trials were bleeding and difficulty breathing. 

Brilinta was approved with a Risk Evaluation and Mitigation Strategy, under which 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 treatment.

Brilinta is now sanctioned in 39 countries including the U.S., Brazil, Australia, Canada, and in the EU (where it is called Brilique) reimbursed in seven countries. AstraZeneca says that the therapy is currently under regulatory review in an additional 45 countries including Russia, India, and China.

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