Our firm is investigating potential lawsuits over antiplatelet medications, such as Plavix and Effient. These blood thinning medications already carry a risk of bleeding, but now federal regulators are reviewing the long-term death risk associated with dual antiplatelet therapies in patients with a coronary stent. If you or someone you know is taking dual antiplatelet therapy, contact our firm today for a free, no-obligation consultation.
Study Finds Higher Death Risk with Long-Term use of Dual Antiplatelet Therapy
Antiplatelet medications are used to prevent the formation of blood clots. Platelets are remnants of cells in the blood; they are necessary to form blood clots and prevent excessive bleeding. When the body suffers an injury, such as a laceration, platelets aggregate together and are then bound by the protein fibrin in order to form a clot and stop the bleeding. Blood clots can be dangerous when they occur within an artery, as is often the case with cardiovascular disease; a heart attack occurs when a blood clot forms within a blood vessel, preventing blood flow to the heart. However, research shows that antiplatelet drugs carry their own risks as well.
Dual antiplatelet therapy is often prescribed to patients who have undergone surgery to implant a coronary stent, which is a tube meant to keep a narrowed blood vessel open. Evidence from the Dual Antiplatelet Therapy (DAPT) Study suggests that using dual antiplatelet therapy long-term in patients with stents is associated with an increased risk of death. The study was conducted by the Harvard Clinical Research Institute and published in the New England Journal of Medicine (NEJM).
The researchers assessed coronary stent patients undergoing dual antiplatelet therapy with aspirin plus either clopidogrel (sold under the brand name Plavix) or prasugrel (Effient) for 12 months compared to 30 months. Although there was a lower risk of heart attack and blood clots at 30 months, the study also found an increased overall risk of death.
Regulators Assess Safety of Antiplatelet Drugs
The findings prompted regulators to review the safety of antiplatelet drugs. On November 16, 2014 the U.S. Food and Drug Administration (FDA) issued a Safety Alert announcing that the agency was reviewing the preliminary data. “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…We will communicate our final conclusions and recommendations when our evaluation is complete.” the agency stated on it’s website.
Health Canada issued a similar announcement on November 18, 2014, stating “Health Canada will continue to evaluate the available information from this trial along with other information, and is aware of the recent communication issued by the U.S. Food and Drug Administration. Health Canada will take appropriate action based on the results of the review once it is complete, including communicating new safety information to health professionals and Canadians as necessary.” The country’s regulatory safety agency advised patients to speak with their doctors about any questions or concerns they have about dual antiplatelet therapy.
Dual Antiplatelet Therapy Patients Who Have Questions
If you or someone you know is taking dual antiplatelet therapy, you may have valuable legal rights. We urge you to contact our Personal Injury attorneys by filling out our online form, or calling 1-800-YOURLAWYER (1-800-968-7529).