July 20, 2011 -- The FDA has approved AstraZeneca's Brilinta blood thinner for patients with acute coronary syndrome -- conditions, such as heart attack and angina, that reduce blood flow to the heart.
Brilinta wears off faster than Plavix and Effient, which are approved for treating the same conditions.
"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," says Norman Stockbridge, MD, PhD, the FDA's director of the cardiovascular and renal products.
The downside of Brilinta is that the drug is less effective if patients take more than 100 milligrams a day of aspirin. A so-called "baby aspirin" contains 81 milligrams of aspirin.
The FDA's approval of Brilinta requires AstraZeneca to institute a Risk Evaluation and Mitigation Strategy (REMS) that will alert doctors to the risk of using higher doses of aspirin along with the drug. This risk will be highlighted in a "black box" warning on the product label. A "black box" warning is the FDA's strongest warning.
The warning will also note that, like Plavix and other blood thinners, Brilinta increases the rate of bleeding and can sometimes cause fatal bleeds. In addition to bleeding, the most common adverse effect of Brilinta was difficulty breathing.
The company will also have to give patients a medication guide every time they refill their Brilinta prescription.
The FDA's approval reverses its December 2010 refusal to approve the drug, despite a 7-1 vote of an expert advisory committee in favor of approval.