Pharmaceutical

FDA to review increased risk of death with long-term antiplatelet therapy

blood cells FDA to review increased risk of death with long term antiplatelet therapyLong-term antiplatelet therapy with another blood thinning therapy has been shown to reduce the risk of heart attacks and the formation of blood clots in stents, but patients were at an increased risk of dying compared to patients on shorter therapy regimes, the Food and Drug Administration (FDA) announced in a Safety Advisory.

The announcement is based on data from a clinical trial that compared long-term antiplatelet therapy of 30 months to patients on 12 months of therapy with either Plavix (clopidogrel) or Effient (prasugrel) in patients following implantation of drug-eluting coronary stents. The patients were also given dual antiplatelet therapy consisting of aspirin. While the increased risk of overall death in patients under dual therapy for 30 months is concerning, the FDA says that the benefits continue to outweigh the potential risks.

Drug-eluting coronary stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. The FDA says clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes and other clot-related diseases.

The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine earlier this month. The FDA has not yet reviewed the trial results or reached any conclusions but issued the safety communication as it continues to evaluate the study’s results. The agency said it would communicate its final conclusions when its evaluation is complete.

In the meantime, health care professionals should not change the way they prescribe these drugs at this time because doing so could result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems.

Health care professionals or patients should report any side effects from these medications to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA