The Food and Drug Administration (FDA) will decide by March 17, 2013, whether to approve the Bristol Myers Squibb’s blood thinner Eliquis (apixaban) for the prevention of strokes in patients with atrial fibrillation. The new drug application for Eliquis has been delayed twice over the past year because the agency requested additional information on data management and verification from a clinical trial. The blood thinner won approval for the same indication last week from European drug regulators.

If approved by the FDA, Eliquis will be the third anticoagulant approved since 2010 for stroke prevention in atrial fibrillation patients – following Pradaxa (dabigatran) in 2010 and Xalerto (rivaroxaban) in 2011. The new class of blood thinners are the first to replace warfarin, which has been on the market for more than 50 years.

Warfarin has numerous interactions and patients who are given warfarin must be monitored on a regular basis to help prevent serious bleeding events. Thus, researchers have long been in search of safer alternatives.

They thought they had found the answer with Pradaxa, but a review of adverse event reports in the FDA’s MedWatch database showed that the drug for the year 2011 had been associated with more deaths than any other monitored medication. Because Xarelto was approved in late 2011, there is not yet enough data to accurately track bleeding events or deaths associated with Xarelto.

A recent article in the Journal of the American Medical Association suggested that the FDA’s urgency to approve new drugs for serious medical conditions has allowed some medications to be cleared with inadequate testing. One of the drugs singled out in this report was Pradaxa, which the report says, “may be more difficult to treat than warfarin-related bleeding.”

This is based on the knowledge that there is no antidote to reverse the clotting effects of Pradaxa, leaving doctors with few options to stop bleeding events when they occur. There are reversal agents to counter the effects of warfarin.

Sources:
Forbes
Righting Injustice

Related posts:

1. Kidney disease increases risk of stroke in atrial fibrillation patients
2. Non-surgical procedure an alternative to blood thinners for atrial fibrillation patients
3. FDA rejects blood thinner Eliquis
4. Pradaxa safety issues cause delay in new blood thinner approval
5. Researchers working on antidote for yet-to-be approved blood thinner