FDA Safety Labeling Changes – Pradaxa Risk of Bleeding and Irreversibly, January 2012

In January of 2012 the U.S. Food and drug Administration, FDA, reported that it had approved safety labeling changes regarding the irreversibility of Pradaxa bleeding and Pradaxa use in patients with kidney damage to the WARNINGS AND PRECAUTIONS section of the Pradaxa (dabigatran etexilate mesylate) label. Changes to the DRUG INTERACTION section were also approved by the FDA

Following are highlights from the January 2012 Pradaxa labeling revisions:

WARNINGS AND PRECAUTIONS/Risk of Bleeding Section

The Pradaxa label now reads:

“A specific reversal agent for dabigatran [bleeding] is not available…Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of dabigatran…”

To the Pradaxa patient, this means that medicalcare professionals are warned that in the case of Pradaxa related bleeds, there is no specific agent that will reverse the ongoing bleed. Control of Pradaxa related bleeding will rely on the time it takes for the patient’s body to naturally eliminate Pradaxa via renal (kidney) elimination. In addition, the revised labeling warns that Vitamin K therapy, a known antidote for warfarin (another commonly used blood thinning medication) related bleeding will not be effective in controlling Pradaxa related bleeding.

The label also warns that Pradaxa’s anticoagulant (blood thinning) activity and half-life (the time it takes for the body to naturally eliminate or inactivate 1/2 of an administered medication) are increased in patients with kidney damage.

To view the complete set of January 2012 revisions to the Pradaxa label, please see Pradaxa Bleeding Risks/Labeling Changes. Always remember to discuss your health related questions with your doctor and do not discontinue a medication without talking to your doctor first and half-life are increase in patient with renal impairment.

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