In a highly anticipated approval, the U.S. Food and Drug Administration has approved pharma giant AstraZeneca’s Brilinta (ticagrelor) which thins the blood with the intention to help patients with acute coronary syndromes, to help lower their odds for heart attack and death.
Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research stated:
“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.”
This means Brilinta has to be taken twice instead of once a day which is a disadvantage in respect of compliance, but its effects are more quickly reversible which can be useful before surgery or if side effects occur. The agency’s move comes after a number of studies found that Brilinta performed well against the standard blood thinner now in use, Plavix (clopidogrel) which is produced by Bristol Meyers Squibb in partnership with Sanofi Aventis.
However, heart patients who took Brilinta with low-dose aspirin (less than 300 milligrams) had fewer cardiovascular complications than those taking Plavix plus low-dose aspirin. This has lead to a FDA “boxed warning” meaning that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The U.S. Food and Drug Administration can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.
However, this warning does not pose fatal circumstances. It only states that the benefit of Brilinta vanished when higher doses of aspirin were used. Taking the drug along with daily aspirin doses above 100 milligrams could decrease its effectiveness. The FDA is also mandating that AstraZeneca “conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin.”
The FDA does note that Brilinta may raise the odds for bleeding. According to the agency the most common side effects seen with Brilinta were bleeding and/or shortness of breath.
Dr. Jeffrey S. Berger, an assistant professor of medicine and director of cardiovascular thrombosis at NYU Langone Medical Center in New York City, said at an American Heart Association press conference:
“The study highlights that if one chooses to use ticagrelor in subjects with acute coronary syndromes, it would be logical to use aspirin 81 milligrams per day (and not 325 mg daily). There is little reason to ever use aspirin 325 mg except in the acute setting of a heart attack or stroke. A higher aspirin dose (325 mg versus 81 mg) increases the risk of bleeding without increasing the efficacy of the drug.”
Written by Sy Kraft