A few years ago we received alerts about an increasing number of serious bleeding episodes associated with the anticoagulant Eliquis (Apixaban). This medication is prescribed to prevent blood clots in patients with an irregular heart rhythm called atrial fibrillation (AFib). The drug is also used to prevent blood clots after knee replacement surgery and to reduce the risks of blood clots in the legs or lungs from deep vein thrombosis (DVT).
Eliquis is one of a new generation of anticoagulants that are being substituted for warfarin (Coumadin). So is Xarelto (rivaroxaban). Many physicians believe that the new drugs are safer and easier to take than warfarin. But in March, 2019 Johnson & Johnson and Bayer settled roughly 25,000 lawsuits involving Xarelto. Lawyers for the plaintiffs asserted that the drug companies did not adequately warn patients about the possibility of life-threatening hemorrhages. How much did the companies fork over? $775 million!
We don’t know about you, but whenever we see a long list of side effects our eyes glaze over. Reading real stories from visitors to this website makes such complications far more concrete. We received this message from Joe:
“Eliquis is the worst drug I’ve ever taken in my life. After only six days I developed all of the following side effects:
SEVERE exhaustion. Couldn’t even walk to the mailbox.
Hypotension (low blood pressure)
SEVERE cognitive failure. Felt like my head was stuffed with cotton.
Periods of rapid heart beat.
BPH (benign prostatic hyperplasia)
Ravenous appetite; absolutely craved carbs. Would have to get up in the middle of the night and eat.”
Many of Joe’s symptoms (insomnia, BPH, cognitive impairment and increased appetite) are not listed in the official prescribing information so it is hard to know if they were really brought on by Eliquis.
This story is from Margaret is far more worrisome:
“I live in Queensland, Australia. My cardiologist transferred me from warfarin to Eliquis 5 mg morning and night in October 2014. I am 78 years old with heart failure plus AF [atrial fibrillation]. Yesterday afternoon I suddenly had a very major nosebleed, 6 paper towels were soaked, 3 hand towels were soaked and one bath towel was wet.
“I rang one of my daughters and she rang the ambulance while she was on her way. The paramedics arrived and quickly brought the nosebleed under control. I was advised by the doctor at the 24 hour clinic to not take the Eliquis and to go see my normal doctor today. I have an appointment to see him at 2.30 pm this afternoon.
“I will be telling my doctor that I want to go back on the warfarin…Yes, it necessitates regular blood tests but it is far safer than Eliquis and the other two drugs that have been developed to replace warfarin.
“No way will I put myself at risk with these new anticoagulant drugs!”
Margaret isn’t the only one concerned about the new generation of oral anticoagulants. The Institute for Safe Medication Practices (ISMP) issues a publication called “Quarter Watch.” It too monitors the FDA’s Adverse Event Reporting System. In the January 9, 2013 issue it noted that:
“Strong signals continued for three anticoagulant drugs, warfarin (COUMADIN) and newcomers dabigatran (PRADAXA) and rivaroxaban (XARELTO). The three drugs accounted for 1,734 reports to the FDA in 2012 Q2, including 233 patient deaths, reinforcing the conclusion that anticoagulants rank among the highest risk of all outpatient drug treatments…”
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On October 17, 2013 the ISMP Quarter Watch reported that anticoagulant medications such as dabigatran (Pradaxa) and warfarin (Coumadin) contributed to the leading drug safety problems reported to the FDA in 2012. The conclusions:
“The 2012 adverse event report data show, in our judgment, that a major priority in drug safety should be to reduce the serious and fatal hemorrhages resulting from treatment with anticoagulant drugs, particularly in the older population with atrial fibrillation.”
Kathy shared this story about visual problems with Eliquis:
“I am having really bad eye issues. Has anybody else had negative eye problems? Sometimes in the night I literally have to use my hands to open my eyes.”
The Bottom Line:
Anticoagulants are important drugs. They reduce the risk of blood clots that can cause strokes and other serious health problems. But these medications must be treated with kid gloves. They require careful dosing and regular monitoring. Patients must be warned about the potential for serious bleeding complications and what to do if they happen. We agree with the experts at ISMP that:
“Numerous steps can be taken to enhance the safety of anticoagulants… More and better information for clinicians is needed about how to manage hemorrhages that occur either as a side effect or as a result of accident or trauma.”
There is now an antidote to to reverse bleeding from drugs like apixaban or rivaroxaban (Xarelto). It is called andexanet alfa (AndexXa). Dabigatran (Pradaxa) has an antidote called idarucizumab (Praxbind). Clinicians need to educate patients about the symptoms to watch out for so that they can recognize a potential bleeding episode early, before it gets out of hand. That way an antidote has a better chance of working.
Want to know more about Eliquis and Xarelto. Here is a link:
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” Read Joe's Full Bio.
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