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The Anticoagulant Wars

Boehringer Ingelheim, not willing to give up its leadership in anticoagulants, has managed to get approval from the Food and Drug Administration (FDA) to include deep vein thrombosis (DVT) and pulmonary embolism in the list of indications for its drug Pradaxa (dabigatran etexilate mesylate). The contender for the throne of Pradaxa is Xarelto (rivaroxaban), the hot newcomer in the field distributed in the US Johnson & Johnson (J&J) in partnership with manufacturer Bayer AG. J&J posted a 3.5% increase in its first quarter earnings for 2014 compared to the same period the previous year, and Xarelto sales contributed significantly to this revenue.

However, J&J and Bayer have had no such luck so far with expanding the use of Xarelto to manage acute coronary syndrome (ACS), embolic stroke, and peripheral artery disease. They have been turned down by the FDA three times for clinical trial design problems, the latest in March 2014, but the two companies are not giving up. They are currently in the throes of three new studies that will hopefully get the nod from the regulatory body. Xarelto is currently approved for ACS in 40 countries outside the US.

The biggest hurdle for Pradaxa in regaining its client base is the ongoing litigation that brings into question the safety of using the drug. It was approved in 2010 and the first lawsuit was filed in March 2012 at the height of its popularity and is currently in multidistrict litigation (MDL). However, Xarelto may be going down the same road. It was approved in July 2011, and the first lawsuit was filed in February 2014. According to the website of law firm Williams Kherkher, more cases are being filed for dangerous side effects. There has been speculation that an MDL may also be in the offing in the near future.

If you are currently on Xarelto and have sustained serious harm from its side effects, don’t be afraid to draw your own gun. Consult with a reputable Xarelto lawyer in your area and find out how you can get compensation for your injuries and losses.

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