FDA Denies Approval for Expanded Use of Blood-Thinning Drug Xarelto®
According to Bloomberg, Johnson & Johnson and Bayer AG have failed to win approval for expanded use from the U.S. Food and Drug Administration (FDA) for its blood-thinning medication, Xarelto®. The FDA voted 10-0 against expanded use of Xarelto®. This denial by the FDA comes after recent reports on the drug’s adverse events, including serious and uncontrolled bleeding.
Johnson & Johnson sought expanded approval to prevent heart attacks and strokes 90 days after patients experience serious chest pain or cardiac illnesses, a condition referred to as acute coronary syndrome. The FDA determined that the effectiveness of the drug was not strong enough to outweigh the serious risk of bleeding, which increases the longer the patient ingests the drug. This is the manufacturers’ third attempt to garner FDA support and expanded approval of Xarelto®.
In July 2011, Xarelto® was approved to prevent blood clots in patients undergoing knee and hip surgeries. The drug was then extended to patients with irregular heartbeats and deadly leg and lung blood clots.
Last year, Johnson & Johnson alone brought in approximately $847 Million in Xarelto® sales. The current market for blood thinning medications, including Xarelto®, is estimated to be worth $10 Billion. The Germany-based pharmaceutical company, Bayer, is still selling Xarelto® in Europe. It is estimated that sales could reach around 3.5 Euros annually.
If you or a loved one has suffered serious injuries after using Xarelto®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
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