http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958lbl.pdf
Doctors performing heart surgery
Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries,has been approved by the FDA for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.
According to the CDC, percutaneous coronary intervention is performed on nearlya half million people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.
By preventing platelets from accumulating, Kengreal reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis).
“For patients undergoing PCI, blood clotting can cause serious problems,” statede Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug eva luation and Research. “The approval of Kengreal provides another treatment option for patients.”
As with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Kengreal.
In a clinical trial that compared Kengreal to Plavix (clopidogrel) in more than 10,000 participants, Kengreal significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis. The overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.
For more information, readers can call 800 Info-FDA http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4308
