Xarelto Litigation Mounting As Drug Makers Push Expanded Uses

Despite a growing number of Xarelto lawsuits being filed nationwide over the potential bleeding risks, as well as three prior rejections by the FDA, Johnson & Johnson and Bayer plan to move forward with attempts to obtain additional approved uses for the controversial anticoagulant.

Xarelto (rivaroxaban) is a relatively new medication, which is part of a new generation of blood thinners, known as “direct thrombin inhibitors”, designed to reduce the risk of blood clots and strokes.

Although it was just introduced in late 2011, Xarelto is already nearing blockbuster status, with sales that may exceed $1 billion by the end of the year. However, serious concerns have emerged about the potential side effects of Xarelto, given the lack of an approved antidote that doctors can use to reverse the effects of the medication if bleeding occurs, resulting in a number of reports involving severe or fatal injuries after doctors were unable to stop hemorrhaging among users.

Amid concerns over the safety of Xarelto, Johnson & Johnson and Bayer, which jointly manufacture and sell the drug, indicated recently that they still plan to seek expanded FDA approvals that would allow them to market the blood thinner among a wider population of users, including patients with acute coronary syndrome (ACS).

Late last month the manufacturers announced three new clinical trials designed to prove Xarelto could be used to combat ACS and other problems. However, the FDA has rejected three previous attempts to expand Xarelto use in that direction, expressing concern over the risk of bleeding events linked to the drug and other medications like it.

Xarelto Bleeding Problems

Xarelto has been aggressively promoted as a superior alternative to Coumadin (warfarin), which has been the go-to anticoagulation therapy for years.

While the manufacturers have claimed that the drug is easier to use than warfarin, since patients do not require regular monitoring during treatment, a growing number of lawsuits filed nationwide allege that the Xarelto warnings fail to adequately disclose the risk of uncontrollable bleeding due to the lack of an approved antidote.

Unlike warfarin, which can be quickly reversed if bleeding occurs, Xarelto lacks a reversal agent to counteract the blood thinning effects of the medication, often leaving doctors unable to control bleeding that may develop among users.

As the popularity of Xarelto has increased over the past two years, a growing number of bleeding complications have been associated with this drug as well.

The recent attempts to expand approval for the medication seems to support some of the allegations contained in recently filed Xarelto bleeding lawsuits, which allege that the manufacturers placed their desire for profits before consumer safety by aggressively marketing the drug with inadequate warnings, while failing to fully explore all potential reversal agents that may make the medication safe.

Many plaintiffs also allege that the benefits provided by the medication do not justify the risks, indicating that the drug makers should issue a Xarelto recall until a reversal agent can be developed.

Last year, Bayer and Johnson & Johnson indicated that they were working with a company called Portola Pharmaceuticals to develop an Xarelto reversal agent, but it appears that they are continuing to aggressively promote expanded use of the medication, even without an approved antidote.