The U.S Food and Drug Administration has denied Johnson & Johnson's and Bayer AG's joint proposal to expand the use of its blood thinner product Xarelto due to incomplete data.
Rivaroxaban, the generic name of Xarelto, is used to prevent blood clots formation due to irregular heartbeat or after a knee replacement surgery. Aside from that, it also used as a maintenance medicine to treat blood clots and prevent their formation. It works by blocking some proteins that makes the blood thicker. Some of the known side effects of the drug are easy bruising and minor bleeding especially if the patient used more than the prescribed intake. There were also a few reports of serious allergic reactions. As a result, it is highly advisable that patients report medical histories to the doctors especially if they had previous problems on their liver, kidney, stroke, surgeries, and other blood disorders.
J&J worked with Bayer AG in a study testing the benefits of Xarelto on heart attack and stroke prevention. They proposed that the drug will be beneficial to patients with acute coronary syndrome (ACS).
According to the American Heart Association, ACS is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. It causes sudden death on the heart tissues; however, it is not the same as heart attack. Some of the symptoms include chest pain or discomfort, pain in the arms, jaw, neck, back or stomach, shortness of breath, nausea, and sweating.
The FDA released an advisory in January that while Xarelto can be used effectively for blood clots and stroke prevention, it cannot be used as maintenance or secondary prevention drug, Reuters reports.
J&J and Bayer failed to provide strong evidence that the drug can effectively heart attacks and strokes from recurring. Another reason was because the data were missing back in 2011, the companies were able to recover the lost data but the proposal was still rejected.
