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An investigative report suggests that there may be rampant misuse of the blood thinner Coumadin in nursing homes throughout the U.S., leading to injuries and deaths among residents.
The independent, non-profit investigative journalism group ProPublica, in association with the Washington Post, published a report on nursing home blood thinner problems this week, detailing how staff members are failing to properly monitor patients taking Coumadin (warfarin).
A review of government inspection reports revealed that at least 165 nursing home blood thinner injuries resulted in hospitalization or death from 2011 to 2014, due to medication mistakes involving the drug.
Coumadin, known generically as warfarin, has been the go-to anticoagulant for decades to prevent strokes among patients with atrial fibrillation. However, to work properly the levels of warfarin in the body must be carefully controlled and monitored.
It is that control and monitoring that appears to be lacking in many nursing homes, where staff members are either improperly trained, not well informed on the use of the drug, or just outright apathetic and negligent. In many cases, the nursing homes have been subjected to fines, penalties, and nursing home neglect lawsuits from family members.
The ProPublica report cites a 2007 study from the American Journal of Medicine, which found 34,000 adverse events ranging from serious to fatal were associated with nursing home use of Coumadin or warfarin every year. However, the study found that while government regulators regularly cite individual homes for misuse of the drug resulting in injury or death, the U.S. Centers for Medicare and Medicaid Services (CMS) appears to have no overall plan for dealing with the problem.
The report contains details of a number of stories of nursing home residents given Coumadin whose blood was not properly monitored, who were given too much or too little, or where nursing home employees failed to recognize the signs of bleeding problems.
The report comes as Coumadin faces a number of new competitors, known as novel oral anticoagulants, which include Pradaxa, Xarelto, and Eliquis.
Pradaxa (dabigatran) was the first member of this new generation of anticoagulants to hit the market, designed to replace Coumadin (warfarin) as the “go-to” medication for prevention of strokes due to atrial fibrillation. Other members of this new class introduced after Pradaxa include Xarelto and Eliquis.
All of the medications have been promoted as superior alternatives to warfarin, because they are supposedly easier to use and do not require frequent doctor visits for blood monitoring to adjust treatment doses. However, with warfarin doctors are able to give a dose a vitamin K and fresh frozen plasma to users who experience bleeding problems, quickly reversing the older drug’s blood thinning effects. No such reversal agents are currently available for Pradaxa, Xarelto or Eliquis.
Within a year after Pradaxa hit the market, it quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.
Boehringer Ingelheim faced over 4,000 Pradaxa lawsuits that allege inadequate warnings were provided about the lack of an available reversal agent for their medication. Following several years of litigation, the drug maker agreed to pay $650 million in Pradaxa settlements last year, with an average of about $150,000 awarded to former users who experienced injuries associated with uncontrollable bleeds.
Xarelto (rivaroxaban) was the second member of this new class of anticoagulants to be approved by the FDA, hitting the market about a year after Pradaxa. However, as Boehringer Ingelheim faced mounting lawsuits and publicity over severe bleeding events associated with Pradaxa, Xarelto has overtaken the top spot among the new medications, with sales exceeding those of Pradaxa in 2013.
A growing number of Xarelto bleeding lawsuits are now being pursued on behalf of former users, raising similar allegations that inadequate warnings were provided about the lack of an approved reversal agent and claiming that the drug makers should have never introduced the medication without an antidote to allow doctors to reverse bleeding events.