FDA Approves New Anticoagulation Reversal Agent and Boehringer Ingelheim Updates Pradaxa Label

Pradaxa Bleeding Risk Pharmaceutical LitigationThe U.S. Food and Drug Administration (FDA) recently approved a reversal agent to be used in patients experiencing serious and uncontrollable bleeding. The anticoagulation reversal agent is called Kcentra, a product developed and manufactured by CSL Behring.

The new treatment counteracts the effects of vitamin K antagonist (VKA) anticoagulation, which could be triggered by the use of an anticoagulant medicine such as Pradaxa or warfarin. The advantage of Kcentra is healthcare providers do not have to thaw the reversal agent, as they commonly do with plasma treatments, nor do they have to match blood type. Removing these two steps from the treatment process leaves more time to quickly treat a major bleeding event.

However, the new reversal agent does come with problematic side effects, including a risk of blood clots and stroke. In the Kcentra news release, the FDA states that in clinical trials and post marketing observations, reports have been submitted about blood clots, stroke, and fatalities in patients who were treated with Kcentra.

It was not made clear in the news release if Kcentra is appropriate in treating patients who use Pradaxa.

As the FDA announced its approval of Kcentra, Boehringer Ingelheim, the German pharmaceutical company behind the anticoagulant medicine Pradaxa, released a statement on April 30 announcing changes to the Pradaxa label.

The update includes a new boxed warning about the heightened stroke risk if Pradaxa use is suddenly stopped. Furthermore, the Pradaxa label will include post marketing observations about the risk of thrombocytopenia, a complication wherein a patient has an unusually low blood platelet count.

The Boehringer Ingelheim release also discusses the addition to the Pradaxa label of RE-LY clinical trial information.

Carey Danis & Lowe Pradaxa lawyers are hopeful that the anticoagulation reversal agent will be able to save the lives of individuals suffering from major bleeding events caused by anticoagulation medications like Pradaxa and warfarin.

Our law firm recognizes the serious health risk posed by Pradaxa, and is encouraging individuals who have been seriously injured through Pradaxa use to contact Carey Danis & Lowe today. Our Pradaxa lawyers are offering free legal evaluations of Pradaxa cases, and can assist in filing Pradaxa lawsuits.

Contact a Carey Danis & Lowe Pradaxa lawyer today by calling 800.721.2519 or by submitting a legal claim form.

References: Pharmaceutical litigation, Pradaxa
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