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For many physicians, choosing between warfarin and the NOACs is all about the bleeding. While newer drugs have a lower incidence of bleeding in clinical trials, concerns have been raised because of widely reported issues with hemorrhaging and the lack of a specific agent to reverse the drug’s effects in an emergency.
In a recent Perspective article in The New England Journal of Medicine, FDA researchers presented results of a Mini-Sentinel analysis of bleeding associated with dabigatran, the first approved and most widely used of the NOACs.
Post-marketing “reports of bleeding were anticipated, but the rate of reported incidents was unusually high and was greater than the concurrent rate of reported bleeding incidents with warfarin,” wrote the authors. They concluded, however, that the “large number of reported cases of bleeding associated with dabigatran provides a salient example of stimulated reporting,” and that the bleeding rate associated with dabigatran was not greater than that of warfarin.2
None of the newer anticoagulants has a clear reversal agent.
“Let’s be clear. There is no real effectiveness data for a bypassing agent,” said Bauer. “If one really needs to deal with a life-threatening bleed, it’s dealer’s choice which to use. The important thing is to get something into the patient quickly. You can use factor VIIA, drugs approved for hemophilia or other inhibitors and bypass agents. Usually, hospitals that treat hemophiliacs carry these medications, as would very large hospitals. We don’t usually carry these at our VA but can access them quickly.”
“It’s important to keep in mind that patients on these drugs aren’t bleeding in the streets or wandering in every night,” noted Jacobson. “If a physicians says, ‘I want to use warfarin because it’s reversible,’ I’d argue the point. For every patient on one of the new anticoagulants that comes in with a bleed in the brain that I can’t reverse, two don’t come in because they do not develop a bleed.”
Further, “most hospitals in the U.S. cannot reverse warfarin fast enough to make a difference in an emergency. If you have an emergent-surgery situation, you can’t wait for the drugs to wear off. You’re going in, regardless. In those situations, warfarin has no fewer postsurgical bleeds than the others,” noted Jacobson.
1 Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. NEJM. 2011;365:2002-2012.
2 Southworth MR, Reichman ME, Unger EF. Dabigatran and post-marketing reports of bleeding. NEJM. 2013;368:1272-1274.
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