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Pete Flowers
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FDA Undertakes Safety Review of Pradaxa…What This Means To You

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Dabigatran (Pradaxa) is a blood thinner known as a direct thrombin inhibitor that was approved to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. Since its approval in October 2010, through August 2011, approximately 1.1 million prescriptions for Pradaxa have been dispensed to some 371,000 patients in the United States.

With that many patients and that many prescriptions, the FDA's announcement will have a troubling impact on many families. On December 7, 2011, the agency announced it was initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug.

In fact, Boehringer Ingelheim Pharmaceuticals is acknowledging 260 deaths associated with the use of Pradaxa. Unfortunately, given sheer number of patients currently taking Pradaxa, the number of deaths or serious side effects is likely to climb as investigations into the drug continue.

If you or a loved one taking Pradaxa has experienced side effects such as:

Severe bleeding or you bleeding that cannot be controlled

Blood in urine or stools

Bruises that occur easily or appear without a cause

Coughing up or vomiting blood

If so, contact your doctor immediately to discuss your medical options. You may also have a claim against the makers of Pradaxa, Boehringer Ingelheim Pharmaceuticals, and we would be happy to discuss it with you at no charge.

Text of FDA Safety Communication:

FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)

Safety Announcement

[12-7-2011] The U.S. Food and Drug Administration (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.