New blood-thinning drug approved by FDA

Angioplasty, a procedure in which a stent is inserted into a blood vessel to open an artery that has been clogged due to atherosclerotic plaque, is widely used to save lives of heart attack victims and others suffering from coronary artery disease. However, it is not without serious complications, one of which is the potential formation of blood clots caused when platelets in the blood clump around the procedure site. This can lead to heart attack, stroke and even death.

Now, Eli Lilley and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd., has received approval by the FDA to market a new blood-thinning drug called Effient, which comes in tablet form, to reduce the risk of blood clots forming in patients who have undergone angioplasty. Prior to approval, Effient (also known by the generic name prasugrel) was the focus of a trial involving 13,608 patients to compare its success rate against Plavix, another commonly prescribed blood-thinning drug. All of the study participants had either had a heart attack threat or an actual heart attack and were about to undergo angioplasty.

In patients receiving Effient, the number who had subsequent non-fatal heart attacks was 7 percent, compared to 9.1 percent in patients receiving Plavix. However, patients with a history of stroke who were given Effient were more likely to have another stroke while taking the drug. And patients taking Effient also had a greater risk of significant and sometimes fatal bleeding. As a result, Effient will carry a boxed warning alerting doctors and patients to the risk of serious bleeding associated with the drug.

"Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure," says John Jenkins, director of the Office of New Drugs, in the FDA's Center for Drug Evaluation and Research. "Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug."

News Release: FDA approves Effient to reduce risk of heart attack in angioplasty patients www.news.xinhuanet.com July 11, 2009

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