In December 2017, Janssen Research & Development, LLC announced its submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new Xarelto uses.
sNDA Application for New Xarelto Uses
The first use would be reducing the risk of cardiovascular (CV) death, heart attack or stroke in patients with chronic coronary artery disease (CAD), and/or peripheral artery disease (PAD). The second proposed use would be the reduction of acute limb ischemia (severe arterial blockage) risk in patients with PAD.
The COMPASS study results were the catalyst for this application submission, as they showed that a twice-daily dose of XARELTO® at 2.5 mg, plus aspirin 100 mg once daily, significantly reduced the risk of major CV events. It was the only randomized trial to explore a Factor Xa (natural blood enzyme) inhibitor for preventing major cardiovascular events in that test group.
Xarelto Bleeding Side Effects
Xarelto, known generically as rivaroxaban, is the most prescribed blood-thinner in its class. Xarelto was developed to prevent serious blood clots like deep vein thrombosis and stroke. Its side effects, however, include fatal bleeding. There are no antidotes to date.
In December 2017, a Philadelphia jury award $28 million to an Indiana woman who developed gastrointestinal bleeding while taking Xarelto. Former FDA Commissioner David Kessler said, “[J & J] did not adequately notify physicians that some patients are at higher risk than others. […] I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be on the label.”
If extensive blood loss wasn’t bad enough, Xarelto’s other adverse effects include abnormal liver function, back pain, or bowel dysfunction. Reversal strategies can range from blood transfusion to surgery.
Xarelto is also among the most heavily promoted drugs with serious side effects that come to light after they’ve entered the market. There are over 21 million Xarelto prescriptions filled in the U.S. alone, and that number will climb along with the number of people adversely affected while Bayer and Janssen Pharmaceuticals benefit.