FDA Advisory Panel Recommends Xarelto for Stroke Prevention

An FDA advisory panel has decided to recommend Xarelto (rivaroxaban) for approval in preventing strokes and blood clots in patients who are suffering from atrial fibrillation.

Xarelto was deemed as safe as an older medication, Warfarin, by the panel in a vote of nine to two, with one member abstaining. This vote didn’t come without its minor controversy since it pits the panel against the FDA’s reviewers who have voted against the drug’s approval. While the FDA doesn’t have to follow the recommendations of the panel, it generally does.

Panel member Philip Sager M.D. tried to explain the panel’s decision to approve Xarelto by saying, “Having treated thousands of patients with atrial fibrillation and dealt with the tremendous problems of using warfarin and patients having issues with warfarin, I think there’s a tremendous unmet medical need for new therapies.” Sager is right with that assessment as many of the current drug treatments for atrial fibrillation have proven to be just as dangerous as the a-fib.

Treatments for atrial fibrillation, a condition that causes patients to suffer from abnormal heart rhythms, include the controversial drug Multaq. Studies of Multaq have linked the drug to liver failure. While Multaq has been approved to treat temporary atrial fibrillation, a recent PALLAS study had to be halted when patients started dying. The PALLAS study was conducted to see if Mutlaq could be approved to treat permanent atrial fibrillation. The maker of the drug, Sanofi-Aventis, has started to formally inform doctors of this and the FDA is reviewing Multaq for its possible links to heart complications.

If you or a family member have developed liver failure or heart complications after taking Multaq for atrial fibrillation, contact attorney Greg Jones for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.

Tags:
Share this article

You May Also Like

All Rights Reserved 2016