FDA Finds Increased Death Risk With Dual Antiplatelet Therapy

The FDA is taking a look at a trial that showed 30 months of dual antiplatelet blood-thinning therapy decreased the risk of heart attack and clot formation in stents, yet increased the overall risk of death compared with 12 months of the treatment.

The FDA is taking a look at a trial that showed 30 months of dual antiplatelet blood-thinning therapy decreased the risk of heart attack and clot formation in stents, yet increased the overall risk of death compared with 12 months of the treatment.

The study examined the use of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient) in patients who had undergone implantation of drug-eluting coronary stents, which were placed in narrowed arteries in the heart to keep the flow of blood to the heart strong.

According to the FDA, the benefits of Plavix and Effient therapy outweigh the negative risks when taken for their approved uses. However, the agency has not yet reached a definitive conclusion based on the trial findings, which were published in the New England Journal of Medicine on November 16, 2014.

The FDA recommends that health care professionals should not change how they prescribe the 2 drugs, and patients should not stop taking the drugs due to the risk of heart attacks, blood clots, strokes, and other cardiovascular problems.

Patients and health care professionals who see or experience adverse reactions related to the use of the drugs can report to the FDA’s MedWatch program at www.fda.gov/MedWatch/report.htm or call 1-800-332-1088 and request a form, which can be mailed in or submitted via fax to 1-800-FDA-0178.