Xarelto (generic name Rivaroxaban) is manufactured by Bayer and is marketed by Johnson & Johnson.

On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved Xarelto, making it one of the newest blood thinners on the market, and specifically for reducing the risk of blood clots associated with deep vein thrombosis (DVT) and pulmonary embolism (PE) after hip or knee replacement surgery.

Thereafter, on Nov. 4, 2011, the FDA expanded Xarelto’s approval for the prevention of stroke in patients diagnosed with atrial fibrillation, the most common cardiac rhythm disturbance.

In the first quarter of 2012, more than 356 reports of serious, disabling, or fatal injury were received on Xarelto, which more than doubled from the previous quarter which reported approximately 128 cases. The primary reported events were pulmonary embolism, the very events Xarelto is intended to prevent.

Nonetheless, in 2012, Xarelto was also approved by the FDA in a ‘fast-track regulatory review’ for the treatment and prevention of the recurrence of DVT and PE in adults.

In September 2013, the a German newspaper Der Speigel, reported 968 adverse events and 72 deaths involving Xarelto that year, in addition to 750 adverse events and 58 deaths the year before, in 2012.

Since 2013, Xarelto has been increasingly connected to cases involving serious internal bleeds, with some resulting in death. Unlike Coumadin, which bleeding events can be treated with vitamin K to reverse, patients on Xarelto have no such antidote.

On Feb. 18, 2014, a complaint was filed against Bayer and Johnson & Johnson in the Philadelphia County Court of Common Pleas, alleging a near fatal bleed as a result of taking Xarelto. The plaintiff in that case stayed several days in the hospital as doctors fought to stop the internal and gastrointestinal bleeding based on ingestion of Xarelto.

As of December 17, 2014, a judicial panel decided that Xarelto lawsuits will be consolidated for multidistrict litigation in Louisiana federal court; other cases remain filed in state court. The judicial panel found that the plaintiffs raised common issues of fact, including concerns about Xarelto’s warning label and the alleged risk of severe bleeding.

According to Bloomberg (12/4/14), as many as 65 deaths have allegedly been linked to the use of Xarelto, and 21 lawsuits have been filed in 10 federal courts.

Lawsuits filed against the makers of Xarelto allege the company failed to warn about the risks and further allege that the drugs were marketed as superior to Coumadin when in fact they had no antidote. Plaintiffs have also alleged that Xarelto was not properly tested before it was approved for the market in 2011.

In 2011, its first year on the market, sales of Xarelto netted $362.3 million for Bayer and $239 million for Johnson & Johnson. In the first half of 2013 alone, the medication netted $420.7 million for Bayer and $347 million for Johnson & Johnson. Bloomberg notes that by 2013, Xarelto made more than $2 billion in sales.

In spite of the danger this medication poses to the consuming public, it is estimated that by 2018, Xarelto will yield in excess of $3.68 billion in sales.