According to the Institute for Safe Medication Practices (ISMP), the U.S. Food and Drug Administration (FDA) received 15,043 reports of injury or death associated with the anticoagulant drug Xarelto in 2016.
This figure reflects a 41 percent increase in the number of adverse reports from the previous year. According to the ISMP, nearly 22,000 reports of serious injury were reported to the FDA during 2016, including 3,018 deaths. Virtually all the injuries linked to Xarelto use involved severe internal bleeding, and resulted in more emergency room visits than any other class of drugs.
More than 18,000 lawsuits are currently pending in multidistrict litigation in Louisiana as well as in state courts in Pennsylvania and Delaware. The cases claim that Johnson & Johnson, Janssen Pharmaceuticals, and Bayer Healthcare not only downplayed the risks of Xarelto, but also aggressively marketed the medication as a more convenient alternative to warfarin, the traditional anticoagulant prescribed for patients at risk for dangerous blood clots and stroke.
The lawsuits also allege that the makers of Xarelto failed to inform patients and medical professionals about the risks of Xarelto use. The drug makers insist that despite the complaints, the bleeding risks associated with Xarelto are fully described on the drug’s warning label and are well known by prescribing physicians.
Two Xarelto lawsuits have already gone to trial in the U.S. District Court, Eastern District of Louisiana, both resulting in verdicts for the defense. The third case is scheduled to go on trial on August 7 in the U.S. District Court, Southern District of Mississippi.
Xarelto, approved by the FDA in 2011, is Bayer Healthcare’s top selling drug, accounting for $3.24 billion in revenue last year, and Johnson & Johnson third-largest seller, generating $2.29 billion in 2016.