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FDA Says No To Expansion Of Xarelto Use-For The Third Time

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The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal.

Xarelto is approved as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems.

Johnson & Johnson was hoping to expand the drug’s use to include patients who have had previous heart attacks or other complications due to acute coronary syndrome (ACS). An application by J & J for the expanded approval of Xarelto to reduce the risk of stent thrombosis, a rare condition in which a blood clot forms on a stent, was also rejected by the FDA.

Why Won’t the FDA Expand its Approval of Xarelto?xarelto 4 xarelto 5

Johnson & Johnson first tried to obtain expanded approval of Xarelto for use in patients with ACS in 2011, and last February’s rejections marked the third time the company’s application has been rejected for expanded use in ACS patients, and the second rejection for those with stent thrombosis.

In February 2014, an FDA advisory panel said that a large amount of data was missing from one of the company’s late stage trials in patients with ACS, making the information flawed and unreliable. In August 2014, Johnson & Johnson and Bayer AG announced plans to launch more clinical trials against three new diseases.

Johnson & Johnson isn’t the first company to try to replace warfarin, another anti-clotting drug – Britol-Myers Squibb Co., Pfizer Inc., and Boehringer Ingelheim GmbH all have similar medications currently in development. But while the new blood thinners are generally easier to take than warfarin, there have been numerous concerns voiced that dangerous bleeding episodes linked to the use of those drugs, including Xarelto, may be harder to control.

Get Help

If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.

Consultations are free and without obligation.

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