WEDNESDAY, July 20 (HealthDay News) -- In a long-awaited move,
the U.S. Food and Drug Administration late Wednesday approved the
blood thinner Brilinta (ticagrelor) for use in patients with acute
coronary syndromes, to help lower their odds for heart attack and
Acute coronary syndromes include common conditions such as
unstable angina or heart attack linked to lowered blood flow to the
heart, the FDA noted in a statement. Brilinta, developed by
pharmaceutical giant AstraZeneca, works to prevent new blood clots
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).
"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," Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
In approving Brilinta, the FDA is mandating a "boxed warning" on
the drug's labeling, advising that 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 boxed warning will also note that, as can happen with blood
thinners generally, Brilinta may raise the odds for bleeding.
According to the FDA, the most common side effects seen with
Brilinta were bleeding and/or shortness of breath.
Late last month, a study presented at an American Heart
Association press conference found that 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. But, as the FDA noted in its approval, that benefit
vanished when higher doses of aspirin were used.
Speaking at the time, Dr. Jeffrey S. Berger, assistant professor
of medicine and director of cardiovascular thrombosis at NYU
Langone Medical Center in New York City, said that "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)."
He added that, "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."
Find out more about preventing heart attack at the
U.S. National Heart, Lung, and Blood