Europe Medicines Committee takes a different view than US FDA committee and give go ahead for Xarelto in acute coronary syndrome

Unfortunately, the US is lagging behind our European counterparts in some aspects of cardiology.  For example, we are still using outdated high blood pressure and cholesterol guidelines when NICE changed the recommendations a while ago. Yesterday, the European Medicines Agency Committee for Medicinal Products for Human Use (analogous to the expert committees that the US FDA uses) made the recommendation to (gave a positive recommendation for) approval of rivaroxaban (Xarelto) after Acute Coronary Syndrome (ACS).

ACS is a broad term that includes Unstable Angina-UA, NSTEMI-Non-ST Elevation Myocardial Infarction-a kind of mild heart attack and STEMI-ST Elevation Myocardial Infarction-or what we usually think of as a heart attack. Using the best medicines to help prevent clots is crucial in these situations as patients are at risk of a first or second heart attack or more severe heart attack after they have had UA or NSTEMI or STEMI.

Surprisingly, the positive recommendation of the European Medicines Agency Committee came weeks after the US FDA asked for more information on the ACS use and did NOT recommend ACS approval.

IF the European Commission accepts the European committee recommendation, rivaroxaban will be approved in a new lower strength of 2.5 mg to be given with aspirin OR aspirin plus clopidogrel (Plavix) or ticlodipine in adults after ACS who have increased biomarkers. This is complicated, but it means that combination therapy may soon be available for people in Europe who are at significant risk of a first or second heart attack, but this will NOT be available for US patients.

Many readers may remember the Essential Guide to Prescription Drugs, 12 Top Meds for 2012 and listing of the ATLAS ACS 2-TIMI 51 study that this author thought would lead to US approval of rivaroxaban in ACS. (Rybacki, JJ. The Essential Guide to Prescription Drugs, 12 Top Meds for 2012, Vol 1, #1: First Edition, the Medicine Information Institute, Easton).

While is certainly makes sense to be cautious with any new medicine, it appears that European committee members are seeing the research on rivaroxaban (Xarelto) in ACS differently than the US committee and FDA.

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