Pradaxa and FDA

FDA approved Pradaxa for prevention of strokes in patients of artrial fibrillation on October 19th 2010. The prescription drug is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. Artrial fibrillation is health condition in which there are very fast and uncoordinated contractions of the heart upper heart chambers. It is one of the most common heart ailments. Patients of with artrial fibrillation have a higher risk of developing blood clots, thus Pradaxa is useful for them.

Pradaxa is an anticoagulant drug. It contains Dabigatran as its main active ingredient. It belongs to an anticoagulant group of drugs called direct thrombin inhibitor. It prevents clotting in the blood. It is used as blood thinner in patients who have clot problems or risk of blood clotting.

It is prescribed to patients of heart disorder for prevention of blood clots and hence reducing the risk of stroke. Sometimes these clots break free from their point of origin and circulated with the blood and can even move to a blood vessel of the brain, and block blood flow to the brain. Due to this strokes are caused. Blood clots could travel to heart or lungs and could cause serious complications. Thus by preventing blood clots or thinning blood this drug reduces risk of some serious health complications. It is prescribed to patients of non-valvular artrial fibrillation.

The safety and efficacy of Pradaxa were found higher than another anticoagulant Warfarin, when tested in a clinical trial. Patients who used Pradaxa suffered less strokes compared to patients taking Warfarin.

Later Pradaxa was linked to excessive and unstoppable bleeding. FDA issued a safety information regarding use of Pradaxa. This safety alert was issued in July 2011 and information was given to public about ongoing FDA evaluation of cases related to serious bleeding due to use of Pradaxa or dabigatran etexilate mesylate.

In December 2011 another announcement came from FDA. It stated that FDA was evaluating reports submitted to the agency’s Adverse Events Reporting System (AERS) regarding bleeding due to Pradaxa. It stated that reports suggest that there is higher occurrence of bleeding cases due to Pradaxa than was expected. It is a newer medicine, thus there is no antidote for it to reverse its side effect and stop bleeding.

FDA maintained at that time that benefits of Pradaxa could not be overlooked. It has proved that, it prevents strokes in patients of artrial fibrillation. Thus it advised patients to use the drug as directed and recommends by the doctor. Doctors should also be aware of approved uses of drug and prescribe it accordingly. Patients of Artrial Fibrillation should use Pradaxa only on prescription of a certified medical practitioner. They should not stop its use without consulting the doctor. It asked both patients and doctors to report any adverse event related to use of Pradaxa to FDA’s Med Watch Safety Information and Adverse Event Reporting Program. It assured that it would communicate any new information related to Pradaxa, as it is confirmed. FDA is evaluating and investigating bleeding due to use of Pradaxa.
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