Is Xarelto the Next Pradaxa?

Xarelto (rivaroxoaban), jointly marketed by Bayer and Johnson & Johnson, is almost chemically identical to another blood thinner and rival product, Pradaxa. In May Boehringer Ingelheim, maker of Pradaxa, paid $650 million to settle approximately 4,000 lawsuits filed by patients who claimed that Boehringer failed to warn them about the drug’s ability to cause serious, irreversible, and sometimes fatal bleeding.

Both Xarelto and Pradaxa are FDA-approved to reduce the risk of strokes and blood clots in at-risk patients. They have been marketed as more convenient alternatives to warfarin, an older treatment, which required the close monitoring of patients’ blood thinning levels. The newer drugs don’t require such monitoring, but they also don’t have an effective antidote to stop a bleeding event—something that warfarin did have (vitamin K).

In 2012, more than 2,000 serious adverse event reports, including 151 fatal events, were sent to the FDA. According to The Wall Street Journal, in early 2013, the number of serious adverse events for Xarelto overtook those for Pradaxa.

This begs the question: will Bayer/J&J face a legal fallout similar to the $650 million dollar settlement paid by Boehringer Ingelheim?

It’s still too early to tell, but attorneys nationwide—including the Denver personal injury lawyers at Andrus Wagstaff—are investigating potential lawsuits on behalf of patients harmed by Xarelto, and lawsuits have already been filed. At this stage, a Xarelto mass tort and Xarelto multidistrict litigation (MDL) appear probable, but it will take time for claimants to come forward and the drug’s science to be better understood.

Xarelto Lawsuits Filed
Reuters reported in June that the first Xarelto lawsuits have been filed. The report gives no details of the suits, but August court filings from a New York District Court give some idea of the types of charges Bayer/J&J will face.

According to the filings, the plaintiffs allege that the drugmakers concealed their knowledge of the drug’s defects, and that this negligent misrepresentation caused the death of their father, who allegedly used Xarelto from May 2013 to August 2013 and died from internal bleeding on December 6.

Drug Companies Press for New Xarelto Uses
Seemingly undeterred by preliminary legal action, Bayer and Johnson & Johnson recently announced plans to hold clinical trials of Xarelto for the treatment of three new diseases: acute coronary syndrome, stroke caused by a clot of unknown origin, and peripheral artery disease. The companies have launched 8 similar studies since 2013, which combined could lead to a doubling of Xarelto’s approved indications.

Xarelto is expected to bring in more than $1 billion in sales this year.

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