Another blood thinner is vying for a top spot to compete against the anticoagulant Warfarin, according to latest news reports. And, the US Food & Drug Administration’s Clinical Reviewer has given her initial approval, leading to a firestorm debate as to whether or not the drug is safe and should be indicated to prevent heart attacks and strokes in patients with Acute Coronary Syndrome (ACS).
The drug is Xarelto and was already approved by the FDA in November to prevent stroke in patients with atrial fibrillation, an irregular heartbeat. The medicine has been on the market since July to prevent blood clots in patients undergoing knee and hip surgeries. According to a U.S. regulatory report it should have a new indication, to prevent heart attacks and strokes in patients with acute coronary syndrome, which would considerably broaden Xarelto’s U.S. market. ACS occurs when a blood clot blocks blood supply to the heart.
Xarelto is one of the medicines attempting to replace warfarin, which requires constant monitoring and dose adjustments to keep blood from getting too thin and putting patients at risk of severe bleeding.
“The benefit risk ratio for Xarelto appears to be favorable, predominantly because there is a reduction in” cardiovascular death “despite an increased risk of major and fatal bleeding,” reviewer Karen Hicks said in the FDA report.
Xarelto given at 2.5 milligrams reduced heart attacks and strokes 15 percent compared with placebo while resulting in a two-fold increase in fatal bleeding and three-fold increases in major bleeding, intracranial hemorrhage, hemorrhagic stroke and minor bleeding that indicated a hemorrhage, according to the report.