The U.S. Food and Drug Administration is evaluating reports of serious bleeding in patients taking PRADAXA.

PRADAXA (dabigatran etexilate mesylate), manufactured by Boehringer Ingelheim, is a blood thinning medication used to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, the most common type of heart rhythm abnormality.

From October 2010 through August 2011, about 1.1 million PRADAXA prescriptions were dispensed and about 371,000 U.S. patients received PRADAXA prescriptions

According to the drug website, PRADAXA can cause bleeding which can be serious and sometimes lead to death. The FDA states bleeding that may lead to serious or fatal outcomes is a well-recognized complication of all anticoagulant therapies.

In a clinical trial of 18,000 patients comparing PRADAXA to warfarin, major bleeding occurred at similar rates with both drugs.

The FDA is working to determine whether reports of bleeding in patients taking PRADAXA are occurring more commonly than expected and is working with the manufacturer to evaluate reports of bleeding.

The manufacturer's of PRADAXA recommend not taking the drug if you currently have abnormal bleeding or if you have ever had an allergic reaction to it. The drug company also reports the risk of bleeding may be higher if you are 75 years old or older; have kidney problems; have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer; take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners; or have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®).

Currently, the FDA believes PRADAXA provides an important health benefit when used as directed and when doctors follow the recommendations in the approved drug label.

The FDA recommends patients with atrial fibrillation should not stop taking PRADAXA without talking to their doctor since stopping the use of a blood thinning medication can increase the risk of stroke. Strokes can lead to permanent disability and death.

Patients should be aware that while taking PRADAXA you may bruise more easily and it may take longer for bleeding to stop.

Also, while taking PRADAXA, the FDA recommends calling your doctor if you develop unusual bleeding from the gums; frequent nose bleeds; heavier than normal menstrual or vaginal bleeding; bleeding that is severe or that cannot be controlled; pink or brown urine; red or black stool; bruises that happen without a known cause or that get larger; coughing up blood or blood clots; vomiting blood or vomit that looks like coffee grounds; unexpected pain, swelling, or joint pain; or headaches, feeling dizzy or weak.

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