June 25, 2012 — The U.S. Food and Drug Administration (FDA) has rejected the expanded use of Xarelto (rivaroxaban) to treat patients with Acute Coronary Syndrome (ACS). FDA reviewers were concerned about flawed and questionable safety data in the ATLAS clinical trial, which was missing important data on patients who withdrew from the study, as well as several uncounted deaths.
Acute Coronary Syndrome (ACS) refers to any symptoms that occur due to sudden, decreased blood flow to the heart muscle. It may develop slowly over time due to the build-up of fatty plaques in the arteries leading to the heart. This increases the risk of heart attack, blood clots, and strokes.
Some people with ACS take a blood-thinning medication to reduce their risk of blood clots, heart attacks, and strokes. However, these medications carry a risk of bleeding. For the last 50 years, the standard treatment has been warfarin, a drug that has a high risk of bleeding but can easily be reversed with a dose of Vitamin K. Xarelto has no such reversal agent, which could potentially be a problem in the event of an accident or unexpected surgery. The anti-clotting effects of Xarelto could potentially cause severe bleeding.
Last month, an FDA advisory committee voted 6-4 against approval of Xarelto for patients with ACS, due to the risk of bleeding. The committee was also concerned about the lack of safety data from the ATLAS clinical trial, which was the foundational safety study conducted by the manufacturers.
The ATLAS study indicated that Xarelto plus conventional anti-clotting medications could reduce the risk of heart attack, stroke, and cardiovascular death. However, the ATLAS study failed to include information on 2,400 patients who withdrew from the trials. Follow-up on these patients was also incomplete. FDA staff who reviewed the application also were concerned that there were deaths in the study that had gone uncounted in the analysis.
The Janssen unit of Johnson & Johnson said in a statement, “We will continue to work with the FDA to fully address their questions as quickly as possible.”
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