Pradaxa Bleeding Reversal May Be Possible

 

In a new study, researchers have identified possible ways to stop internal bleeding caused by a proposed blood thinner that belongs to the same class of drugs as Pradaxa. Pradaxa has been linked to hundreds of injuries and deaths as a result of internal bleeding caused by the anticoagulant.

In research published last week in the American Heart Association journal, Circulation, researchers have identified at least three ways to stop the blood thinning effects of Eliquis, a new anticoagulant in development by Bristol-Myer Squibb.

Eliquis has limited European approval, but has not been cleared by the FDA for use in the United States.  It is a member of the direct thrombin inhibitor class of blood thinners, which inhibit the enzyme that causes blood to clot.

Pradaxa (dabigatran) was the first drug in this class, approved for use in the United States in October 2012.  It was followed by Xarelto in November 2011.  Eliquis is Bristol-Myer Squibb’s addition to the class, but the FDA announced earlier this year that it would delay a decision on this blood thinner at least three months.

Each of these drugs has been marketed as a superior alternative to warfarin (Coumadin) because they are easier to dose and require less patient monitoring.  However, when a person develops a bleed after taking warfarin, it can be reversed with a  dose of Vitamin K. There is currently no such reversal agent for the new drugs.

In this new study, researchers state that they have found three reversal agents for Eliquis.  The best of these three methods will have to be determined through clinical trials.

Since its release, Pradaxa has been linked to more adverse event reports than any other drug on the market, as is stated in a recent report from the Institute for Safe Medication Practices.  In 2011, 3,781 Pradaxa problems were reported, including 542 patient deaths.  Boehringer Ingelheim, maker of Pradaxa, is also working on finding an effective reversal agent for internal bleeding.

The FDA announced last fall that they were launching a review into Pradaxa adverse event reports.  Some critics feel that a Pradaxa recall should be issued.

In May, regulators in Europe concluded a Pradaxa investigation, concluding that the benefits of the drug still outweigh the risks.  Still, the Europan Medicines Agency also recommended that stronger warnings be placed on Pradaxa labels.

Contact a Pradaxa Lawyer

If you or a loved one have suffered a Pradaxa bleeding event, you may be entitled to compensation in a pharmaceutical product liability lawsuit.  Contact a Pradaxa lawyer to learn  more in a free legal consultation.

 

July 2, 2012 | Tags: Dangerous Drugs, Pradaxa

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