The FDA approved Johnson & Johnson and Bayer's anti-clotting drug Xarelto for the treatment of atrial fibrillation, according to a CBS News report.
The makers of Xarelto wanted the FDA to approve a claim that Xarelto was more effective than Coumadin — a blood thinner used for more than 50 years — at preventing blood clots and stroke. The agency declined. Xarelto will carry a safety warning stating that patients should not stop taking the drug without notifying their physicians, as discontinuing the drug can increase the risk of stroke.
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The makers of Xarelto wanted the FDA to approve a claim that Xarelto was more effective than Coumadin — a blood thinner used for more than 50 years — at preventing blood clots and stroke. The agency declined. Xarelto will carry a safety warning stating that patients should not stop taking the drug without notifying their physicians, as discontinuing the drug can increase the risk of stroke.
Related Articles on FDA Approvals:
FDA Reports Increase in New Drug Approvals in FY 2011
FDA Approval for Edwards' Sapien Device is a First for U.S. Market
FDA: Medtronic Catheter Effective, But Doesn't Meet Safety Goals