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FDA Rejects a New Use for Xarelto

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FDA Rejects a New Use for Xarelto

Xarelto, an alternative to warfarin, the traditional treatment for atrial fibrillation, has suffered another rejection by the FDA. This is the second time that Johnson & Johnson has tried to get Xarelto approved to treat acute coronary syndrome, and the second time the FDA has refused to do so.

Acute coronary syndrome is a broad term that encompasses the range of symptoms that result from a sudden, reduced blood flow to the heart. Symptoms, such as chest pain, pain in the jaw or the upper arm, nausea, vomiting, and shortness of breath, are similar to those of a heart attack, and if ACS is not treated, it can result in a heart attack. ACS is responsible for over 1.2 million hospitalizations a year.

Many drugs are available to treat ACS, from aspirin to beta blockers, but as of now, Xarelto will not join their ranks. The FDA first rejected Johnson & Johnson’s application in June of 2012 due to missing data on trial participants who had pulled out of the trial, and inconsistent record keeping. Despite the fact that the company provided more data, it was not enough to offset the increased risk of bleeding that is a known side effect of Xarelto.

Xarelto has been plagued with problems and bad publicity because of its risks of bleeding. While Xarelto and Pradaxa were heralded as new Despite these facts, the FDA rejected Johnson & Johnson’s attempt to get Xarelto approved for the treatment of ACS. As of now, Xarelto is approved for the treatment of several indications:

    • To reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism, or lung blood clots (PE) after knee and hip replacement surgery
    • To reduce the risk of stroke in people who have non-valvular atrial fibrillation
    • To treat DVT and PE and to reduce the risk of recurrent DVT and PE

Just days after the FDA’s latest rejection, Johnson & Johnson and Bayer are trying their hand at getting Xarelto approved for wider use in another way: for patients with chronic heart failure and significant coronary artery disease. The pharmaceutical companies are determined to expand Xarelto’s approved uses in order to reach $2.5 billion in annual sales.

Do you think that this is a legitimate way for pharmaceutical companies to approach their products? While these drugs are invaluable for those who need them, it seems that Bayer and Johnson & Johnson are throwing everything they can think of at the wall, hoping that something will stick and drive up their sales numbers. With the risks of uncontrollable bleeding as high as they are with this new generation of anti-coagulants, more uses and more patients means more drug injuries.

If you or a loved one have been injured by Xarelto, Pradaxa, or any other drug, contact a dangerous drug attorney at Kirkendall Dwyer LLP. We have a great deal of experience in these cases, and can help you get the compensation you deserve. Contact us today for a free case review.

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