FDA Rejects Expanded Xarelto Use for ACS patients

Earlier this year, the Food and Drug Administration said no to two requests made from Johnson & Johnson regarding the use of Xarelto for patients with acute coronary syndromes (ACS). The FDA has rejected general Xarelto use on ACS patients, as well as the use of Xarelto to treat stent thrombosis.

Xarelto was initially praised in tests and it was thought that it would be the first anticoagulant approved for use on ACS patients. Later, the FDA’s Cardiovascular and Renal Drugs Advisory Committee later voted against this indication for the drugs amid concerns by FDA reviewers. Europe’s equivalent agency approved general use of Xarelto for ACS patients in May.

According to a September article from Reuters, the German magazine Der Spiegel has reported increased reports of side effects in European patients. Germany’s Federal Institute for Drugs and Medical Devices stated that there had been 968 cases of undesirable side effects from the drug in the first 8 months of 2013, including 72 deaths. In the entire year of 2012, there had been 750 cases of side effects and 58 deaths.

A joint effort from Johnson & Johnson and Bayer, Xarelto was first approved as a blood thinner intended to reduce strokes and blood clots in people with atrial fibrillation in late 2011. Xarelto inhibits the effects of thrombin, which is responsible for clotting. It is one of Bayer’s most important new drugs, Reuters reported, expected to bring in annual revenues of more than $2.5 billion. The Levensten Law Firm is examining the legal rights of those who had unexpected and undesirable side effects while taking Xarelto. If you have experienced a serious bleeding event and you believe it was caused by this drug, contact us today.