Pradaxa Bleeding Risk Report Overlooks Lack of Antidote

A new report released last week found that the anti-stroke medication Pradaxa does not pose a higher risk of serious bleeding in patients than its predecessor drug warfarin.

But the report from the Food and Drug Administration (FDA) failed to address one critical fact about the two drugs: With Pradaxa, there is no antidote to stem a patient’s bleeding once complications arise, reports The New York Times. With warfarin, vitamin K or other substances can be used to reverse its effects although it too can be fatal.

Although the FDA’s report says Pradaxa is still safe when used as directed, some critics believe that given the lack of an antidote to reverse its potentially deadly effects, the drug’s use should be limited and there should be better disclosure of the risks, according to the Times.

More than 500 deaths associated with Pradaxa were reported to the FDA last year and so far around 100 Pradaxa lawsuits have been filed in federal court against its maker, Boehringer Ingelheim.

Pradaxa and warfarin are blood-thinning drugs used to prevent clots in patients with non-valvular atrial fibrillation or irregular heart rhythm. The FDA’s analysis found that bleeding rates associated with Pradaxa are not higher than those associated with warfarin. The findings of the FDA investigation are in line with the observations from the RE-LY trial that was the basis of the approval of Pradaxa.

The FDA says that the agency has not changed its recommendations regarding the drug. They only indicate that healthcare professionals need to be careful that Pradaxa is prescribed according to its dosing recommendations and that those on Pradaxa -- particularly patients with kidney impairment -- are regularly monitored. People who are prescribed Pradaxa by their doctors should not stop or discontinue the medication without consultation.

The FDA says it is continuing to evaluate multiple sources of data in the ongoing safety review of Pradaxa.

If you or a loved one has been harmed by a dangerous drug like Pradaxa, contact Sokolove Law today for a free legal consultation and to find out if a Pradaxa lawyer may be able to help you.

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