FDA Rejects New Use for Blood Thinner Xarelto
Vote Follows Panel Recommendation From Last Month
Missing Data Cited by Panel continued...
The FDA is scheduled to rule on whether or not to approve the third new blood thinner, Bristol-Myers Squibb's and Pfizer's Eliquis, by the end of the month.
While the new blood thinners are easier to take than warfarin, there have been concerns that dangerous bleeding episodes linked to the use of the drugs may also be harder to control.
In patients taking warfarin, which works by blocking vitamin K, doctors can reverse the blood thinning effects if they need to in a few hours by administering the vitamin or by giving patients blood clotting agents.
It is not clear if blood clotting drugs work as well to reverse the blood thinning action of the new medications.
Early laboratory studies suggest that some of the strategies used to reverse the blood thinning action of warfarin may also work with the new drugs.
But Elmhurst, Ill., cardiologist and American Heart Association spokesman Vincent Bufalino, MD, tells WebMD that these trials are preliminary and there is, as yet, no consensus on how to best reverse the actions of the new drugs in emergency situations.