FDA Issues Safety Announcement regarding Risks of Long-Term Antiplatelet Therapy
The FDA has issued a Safety Announcement regarding the safety information and preliminary data from the Dual Antiplatelet Therapy (DAPT) trial, which was published in the New England Journal of Medicine on November 16, 2014.
The FDA stated that it 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 FDA added: “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. These stents are small, medicine-coated tubes inserted into narrow arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases.”
At this time, the FDA believes that the benefits of Plavix and Effient, when used for approved uses, outweigh their potential risks. However, the FDA is continuing to evaluate the results from this trial and other data available at this time, and will communicate its final conclusions and recommendations after its full evaluation.
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