In this post, “PRADAXA Promising Drug, Empty Promises with Higher Risks“, from November 2012, we examined the rise in PRADAXA (DABIGATRAN) side effect lawsuits over claims the anti-coagulant had lead to hundreds of internationally reported deaths. Lawsuits were filed and centralized in an MDL. After months of contentious litigation, including nearly $1M in discovery sanctions being awarded against the manufacturer, the case was settled in May 2014 for $650M as reported by the NYTimes in “$650 Million to Settle Blood Thinner Lawsuits“. Our office represented several families that lost loved ones while taking PRADAXA. Lawyers from across the country represented other families on no recovery, no fee basis to seek justice and compensation for victims or their loved ones. These individuals literally bled to death. In the wake of these lawsuits a new anticoagulant has emerged as the Blockbuster Heir Apparent – XARELTO (RIVAROXABAN).
XARELTO(RIVAROXABAN), like PRADAXA (DABIGATRAN), is a one of three new anti-coagulants that have been heralded as being a worthy replacement to WARFARIN or COUMADIN. The third is ELIQUIS (APIXABAN). WARFARIN and COUMADIN are known agents in the medical field. Use of the anti-coagulant comes with decades of science and “how to” literature and a list of “don’ts“. The restrictions on using WARFARIN or COUMADIN are what make these new anti-coagulants appealing. The old guard requires dietary restrictions and routine monitoring to determine effectiveness. This monitoring can be a deterrent to some as it poses an inconvenience. The marketing messaging for the new anti-coagulants has made this a prominent part of their messaging. “Convenient oral dosing with no routine coagulation monitoring” is part of the appeal to prescriber and consumer alike. XARELTO(RIVAROXABAN) is FDA approved for six (6) indications as illustrated below and marketed to physicians with these FDA approved uses in mind.
In sum, all the new generation anti-coagulants have put the lack of restrictions at the forefront of their marketing to appeal to prescribers and users. After all, both the patient and prescriber become involved in ongoing monitoring and therein lies motivation for everyone involved in the decision making process. However, if the underlying data and safety profile turn out to be other than that initially shown to the FDA for approval, there is arguably reason for concern. Knowingly accepting risks or side effects requires full disclosure of risks and the manufacturer is in the best position to bear this burden as they develop and bring their drugs to market.
XARELTO(RIVAROXABAN) has no publicly available or known antidote. As a result, any patient undergoing treatment may bleed out if cut, or internally bleed if they suffer a traumatic event. Elderly patients are at high risk for falling events and the use of such anti-coagulants sets them up for a potentially fatal event. Patients undergoing hip replacements, knee replacements or already at risk for blood clots are vulnerable to begin with even before taking XARELTO(RIVAROXABAN). Adding the no antidote anticoagulant adds more risk and uncertainty and we need only look back to PRADAXA (DABIGATRAN) side effect lawsuits to understand this history. In fact, in the United States, it was such a fatal fall being reported in medical journals that brought the risks, and frustration of treaters, to the forefront along with hundreds of deaths worldwide. That fall would not have otherwise been fatal, it was the no antidote nature of PRADAXA (DABIGATRAN) that contributed to the outcome.
XARELTO(RIVAROXABAN) is manufactured by BAYER and promoted by JANSSEN in the United States. As news emerged of hundreds of deaths being linked to patients using PRADAXA, and the manufacturer becoming embroiled in complex nationwide litigation in the United States, these companies were able to grow their market share of XARELTO(RIVAROXABAN). In other words, as demand declined for PRADAXA – XARELTO filled a void previously occupied by either WARFARIN, COUMADIN or PRADAXA. ELIQUIS is simply too new to the market based upon a later FDA approval than these predecessors.This phehomena translated into the drug, XARELTO(RIVAROXABAN), gaining Blockbuster status, marked by $1B or more in sales, with analysts predicting sales could reach $3.7B by 2018. Bayer’s CEO has been repeatedly quoted as predicting that the company would achieve $2.5B in annual sales with the novel drug. Astronomical sales and continued projections of growth, as well six FDA indications for use, have not proven enough for the manufacturers and promoters. In fact, they have tried three (3) times to expand the indication of XARELTO in the United States and been denied this request by the U.S. Food & Drug Administration (FDA).
In September 2013, reports emerged in Germany that XARELTO had been linked to 968 side effect reports, which included 58 deaths, with German drug regulators. The German Newspaper, Der Speigel was credited with highlighting the story and potential identification of a “safety signal” or what most people would call a “red flag”. In “Bayer’s Xarelto Faces Stepped-Up Reports of Side Effects, Deaths“, Tracy Staton, explored parallels between XARELTO(RIVAROXABAN) and PRADAXA, as well as the reports from overseas. Staton’s story again cites Bayer’s CEO Marijn Dekkers as having been repeatedly noted as having articulated expectations that the drug can sell over $2B in annual sales. The perceived financial promise of XARELTO(RIVAROXABAN) should raise more red flags and safety signals.
On October 17, 2013, the Institute for Safe Medication Practices, (ISMP) released an QuarterWatch, Monitoring FDA MedWatch Reports, Executive Summary, Data from 2012 Quarter 4 and Annual Report. This summary examined reports to the FDA for 2012. At that time, and for the second straight year PRADAXA and WARFARIN were the main suspect in direct reports to the FDA. XARELTO(RIVAROXABAN) was gaining similar notoreity and ranked tenth. ELIQUIS did not register any reports and this is likely given to the fact it was not FDA approved until December 2012.
Considering PRADAXA, XARELTO(RIVAROXABAN) and COUMADIN, these three anticoagulants combined for 6,234 cases of serious injury and 789 patient deaths. That is based upon volunteered information and self reports because not all side effects are reported to the FDA.
In prior reports QuarterWatch had deemed anticoagulants one of the most dangerous outpatient drug treatments available and linked them to tens of thousands of emergency room visits or hospitalizations. In conclusion, QuarterWatch interpreted data from 2012 as supporting the need for prioritization in drug safety to reduce the number of serious and fatal hemorrhages from anticoagulants, particularly in the older population with atrial fibrillation. This is the very demographic that new, no antidote, anticoagulants are targeting and reaching.
Most recently, the ISMP released QuarterWatch, Monitoring FDA MedWatch Reports, Data from 2013 Quarter 1. Their analysis included a finding that approximately 15% of patients that use anticoagulants for a one year period suffer from some bleeding. Their data also confirmed that reports of problems with XARELTO were out numbering similar reports for PRADAXA. Total dispensed outpatient prescriptions for XARELTO were nearly 1 Million per quarter and by the end of 2013 these prescriptions out numbered PRADAXA 2 to 1.
Regrettably, history has repeated itself as new anticoagulants have gained market share and acceptance. Safety signals originally detected with PRADAXA were first noticed overseas. In the cae of XARELTO(RIVAROXABAN), German drug regulators reporteldy knew, per Der Spiegel, of the potential for safety concerns. Yet again, in the United States, where reports of adverse events are voluntarily submitted, if at all, by the medical community, the industry has been left to police itself. The FDA relies upon the adverse event reporting system (FAERS) as the cornerstone of postmarket surveillance of approved drugs. However, it is only after growing reports and litigation that widespread institutional knowledge of problems is often brought to light.
There will be a marked rise in XARELTO(RIVAROXABAN) related litigation as a result of XARELTO(RIVAROXABAN) side effects leading to fatalities and bleeds. On June 14, 2014, REUTERS reporters Frank Siebeld and Jonathon Gould, reported in “Bayer Faces Lawsuits in United States over Xarelto: Paper” and cited German news source, Frankfuter Allgemeine Zeitung, in identifying at least ten (10) lawsuits against BAYER. This report also cites annual sales of $1.3 Billion in 2013. REUTERS reporting on pend
ng U.S. lawsuits and relying upon German news sources as authority sounds all to familiar given the history of safety signals and emerging reports originating overseas. Given the safety signals noted above, as well as the growth in prescriptions, it is likely that this litigation will grow as exponentially as the outpatient prescriptions. Whether consumers and the prescribing physicians were properly or adequately informed of risks, or the safety profile of this no antidote novel anticoagulant will be a central question to legal claims.
Our office is investigating XARELTO(RIVAROXABAN) side effect lawsuits involving fatalities or bleeding events. FREE CONFIDENTIAL CASE EVALUATIONS are available by calling (954) 524-2820 or submitting your request for contact.
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