Pradaxa safety issues cause delay in new blood thinner approval
Safety issues following the October 2010 approval by the Food and Drug Administration (FDA) of the blood thinner Pradaxa are being blamed for the three-month delay in the decision on a new blood thinner.
Apixaban (Eliquis), made by Pfizer and Bristol-Myers Squibb, was set for FDA review in March but regulators opted to extend the deadline. The FDA had previously granted the application of a six-month priority review, which would have resulted in a decision by March 28. The new decision date is June 28.
Eliquis is an anticoagulant indicated for the prevention of stroke in patients with a type of irregular heartbeat known as atrial fibrillation. The drug would go head-to-head with Pradaxa (dabigatran), the first blood thinner to be approved by the FDA since warfarin (Coumadin) hit the market more than five decades ago.
Safer alternatives to warfarin have long been sought. Warfarin can increase the risk for internal bleeding, requiring patients who use the drug be monitored.
However, since its approval, Pradaxa has raised safety concerns of its own. At least 505 bleeding events have been linked to Pradaxa. And, the drug has been linked to 256 cases of serious, spontaneous bleeding episodes resulting in death.
The difference between bleeding events with warfarin and bleeding events with Pradaxa is that there is no antidote for Pradaxa, leaving doctors helpless when bleeding problems arise in patients using Pradaxa.
The experimental new blood thinner Eliquis was approved by the European Union for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. It is not yet approved in any country for the prevention of strokes in patients with atrial fibrillation, though several clinical trials are currently underway.
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