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May 22nd, 2012 
FAKE NEWS for the Zionist agenda MONDAY, May 21 (HealthDay News) — The new blood thinner Xarelto
appears to lower the chances of potentially fatal blood clots in high-risk
heart patients, a U.S. Food and Drug Administration review has found.
The review came in briefing documents that were filed Monday in advance
of an FDA advisory panel meeting Wednesday, at which the panel is to vote
on whether to recommend approval of Xarelto for treating people with acute
coronary syndrome (a group of conditions brought on by sudden reduced
blood flow to the heart).
The FDA is not required to follow the advice of its expert panels, but
the agency typically does. A final decision is expected by the end of
June, according to the documents.
Xarelto (rivaroxaban) is one of a new class of blood thinners that have
been developed to overcome some of the problems that exist with the
standard treatment, warfarin (Coumadin), which requires constant dose
monitoring. Warfarin’s effectiveness also can be altered by certain foods
and other medications. Xarelto already is approved for use by those with
atrial fibrillation (irregular heartbeat) and by people who are having
hip- or knee-replacement surgery.
In the FDA briefing documents, an agency reviewer recommended approving
the drug for treatment of acute coronary syndrome, mostly because trial
data showed there was a reduction in cardiovascular death, even though
there was also an increased risk of potentially fatal bleeding.
“However, what is not reflected in the sponsor’s analysis are minor
bleeding events,” FDA reviewer Dr. Karen Hicks wrote in the briefing
documents. “While it is true that these bleeding events typically do not
lead to death or irreversible harm, these events may represent the biggest
problem for both patients and health care providers if rivaroxaban is
approved.”
“While reductions in [cardiovascular] death still trump these bleeding
events, if rivaroxaban is approved, we should expect a number of bleeding
events that will require medical attention,” Hicks wrote. “Carefully
selecting patients for rivaroxaban therapy will be necessary to mitigate
these bleeding risks.”
In research presented at the American Stroke Association’s
International Stroke Conference in New Orleans last February, Australian
doctors followed more than 14,000 people who took either Xarelto or
warfarin for a median of two years. Of those patients, 136 had bleeding in
the brain.
People who took Xarelto — and suffered from the most common type of
atrial fibrillation and didn’t have heart valve damage — were about
one-third less likely to experience bleeding in the brain than those who
took warfarin, the investigators found.
More information
The U.S. National Institute of Neurological Disorders and Stroke has
more about stroke.
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