The U.S. Food and Drug Administration (FDA) has approved the anti-platelet drug ticagrelor for patients with acute coronary syndromes (ACS).
A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication. It also notes that, like other anti-platelet agents, ticagrelor increases the rate of bleeding and can cause significant, sometimes fatal, bleeding.
Ticagrelor was approved with a Risk Evaluation and Mitigation Strategy, a plan to help ensure that the drug’s benefits outweigh its risks. As part of that plan, the company must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, the drug will be dispensed with a Medication Guide that informs patients of the most important information about the medication.
The FDA had postponed it's decision this past December and requested additional analysis of the PLATelet inhibition and patient Outcomes (PLATO) clinical trial before approving the new drug application. The PLATO study, which evaluated 18,624 patients, found that ticagrelor decreased incidences of cardiovascular death, MI and stroke when compared with clopidogrel. The European Commission approved the drug in early December 2010 for the prevention of atherothrombotic events in ACS patients.
The ACC and American Heart Association will be including ticagrelor in upcoming guidelines.