Product News and Recalls

FDA sets deadline for blood thinner approval

According to Reuters, the U.S. Food and Drug Administration has set March 17 as the deadline for deciding whether to approve blood thinner Eliquis for patients with atrial fibrillation.

The agency declined to approve the drug in June, requesting that manufacturers Bristol-Myers Squibb Co and Pfizer Inc. provide more information on a pivotal clinical trial of the medicine, which is designed to reduce the risk of stroke caused by blood clots in heart patients.

Eliquis, chemically known as apixaban, is Bristol-Myers Squibb Co and Pfizer Inc.’s entry in a high-stakes competition among pharmaceutical companies to produce a replacement for standard blood-clotting treatment warfarin. While effective, warfarin requires frequent testing and dietary restrictions.

But some of the ostensible replacements have generated even more serious problems.

Pradaxa, created by Boehringer Ingelheim, has been the subject of 3,781 adverse effect reports to the FDA last year, including 542 deaths. Pradaxa surpassed all other monitored drugs in that regard.

Compounding the problem is that fact that no antidote available for Pradaxa-related bleeding emergencies. The FDA is now conducting a safety review of Pradaxa.

According to Reuters, both Wall Street and the medical community widely expect approval of Eliquis, which proved to be more effective in clinical trials than warfarin.

Atrial fibrillation, a common form of dangerously irregular heartbeat, is widely regarded as the largest and most important use for the new blood clot preventers. An estimated 12 million people in the United States and Europe have the condition, which puts them at high risk of suffering a stroke.

A committee of experts for European regulators recommended its approval in all 27 European Union member states, as well as Iceland and Norway.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a lawyer if you have injuries connected with Pradaxa.