FDA Drug Safety Communication Issued In November 2014 About The Dual Antiplatelet Therapy (DAPT) Trial Which Was Published In The New England Journal of Medicine
(Posted by Tom Lamb at DrugInjuryWatch.com)
Plavix (clopidogrel) and Effient (prasugrel) are important antiplatelet blood-thinning medicines used to prevent heart attacks, strokes, and other clot-related diseases.
The Dual Antiplatelet Therapy (DAPT) trial was published by the New England Journal of Medicine (NEJM) on November 16, 2014 in this article, "Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents".
That same day came this related item, "FDA Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death", from which we get this information:
FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents....
FDA has not reviewed the trial results or reached any conclusions based on the findings from this clinical trial. We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete.
We will watch for the FDA's follow-up communication as regards this Plavix - Effient drug safety investigation and report significant developments here.