FDA Drug Safety Communication

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. These stents are small, medicine-coated tubes inserted into narrowed 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.

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on November 16, 2014. 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.

The DAPT trial is a public-private collaboration to study the optimal duration of antiplatelet therapy after stent placement. The trial examined the effects of dual antiplatelet therapy for 12 months compared to 30 months in approximately 10,000 patients with an implanted drug-eluting coronary stent. The risks of stent thrombosis and heart attacks in the group receiving treatment for 30 months was reduced compared to 12 months; however, there was a higher rate of death in the 30-month treatment group. The higher rate of death was largely explained by an increase in deaths from non-cardiovascular causes, primarily cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not those given prasugrel. It should be noted that increases in non-cardiovascular death have not been reported in previous large trials examining clopidogrel for other cardiovascular diseases.

View the full FDA Drug Safety Communication on FDA.gov