FDA Approves New Anticoagulant to Reduce Stroke Risk

Posted by The Evidence Blog on January 16, 2013

A third novel anticoagulant has just been approved by the Food and Drug Administration (FDA).

The FDA has approved the oral anti-clotting drug apixaban (Eliquis; Bristol-Myers Squibb) to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation is an irregular and rapid beating of the heart that allows the formation of blood clots. Blood clots in the heart can cause a disabling stroke if the clots travel to the brain; anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming. Eliquis is manufactured by Bristol-Myers Squibb and will likely be marketed as a successor to Plavix, which lost its patent protection in May 2012.

Eliquis joins dabigatran (Pradaxa) and rivaroxaban (Xarelto) as the third new-generation anticoagulant to be approved by the FDA. These drugs are of great interest because unlike Coumadin—the older and very commonly prescribed anticoagulant—they are absorbed much more quickly, have far fewer food and drug interactions, and obviate the need for patient monitoring.

Patients with prosthetic heart valves should not take apixaban; the same warning now also applies to Pradaxa. As with other FDA-approved anti-clotting drugs, life-threatening and fatal bleeding is the most serious risk with Eliquis. This is especially important because there is no agent that can reverse the anticoagulant effect of Eliquis.

As a condition of approval, the manufacturer is required to provide a Patient Medication Guide that provides instructions on its use and drug safety information. According to the manufacturer, Apixaban will cost approximately $250, which is comparable with the cost of dabigatran and rivaroxaban.

While some experts have argued that Eliquis offers the best balance between the drug’s benefits and risks, there have been no clinical trials comparing the three new drugs, making it difficult to assess which of these new agents is the preferred one.

Are you likely to prescribe one of these new anticoagulants? How do you choose among the three?
Click to view the Hayes News Service article.

Topics: Hayes Blog

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