Preliminary data from a clinical trial has prompted safety regulators to review the safety of using duel antiplatelet therapy long-term. On Sunday, the U.S. Food and Drug Administration (FDA) issued a safety announcement stating that it was evaluating this data.
The data stemmed from The Dual Antiplatelet Therapy (DAPT) trial; findings were published in the New England Journal of Medicine on November 16th. Although the study found a decreased risk of heart attacks and clot formation in stents with 30 months of dual antiplatelet therapy, there was an overall higher risk of death compared to 12 months of treatment. Researchers looked at patients who underwent dual treatment with the aspirin plus either clopidogrel (Plavix) or prasugrel (Effient) after undergoing stent implantation. Stents are often used in patients with narrowed arteries; they are essentially tubes that are intended to maintain blood flow and keep the vessels open.
“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 FDA stated.
Health Canada is taking similar action. On Tuesday, the regulatory agency posted on its website “Health Canada is aware of and will be reviewing new evidence on the safety of long-term use of the prescription blood-thinners clopidogrel (Plavix) and prasugrel (Effient)… 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.”