In our inbox yesterday morning was a media alert from Adverse Events, Inc., regarding the anticoagulant Eliquis (apixaban) and some new cases of colon cancer and liver injury. There is nothing in the official prescribing information regarding such possible complications.
This healthcare informatics company monitors FDA’s Adverse Event Reporting System (FAERS) looking for signals of drug problems. The researchers also obtain insider data from the FDA through the Freedom of Information Act (FOIA). This is just the latest alert regarding Eliquis, a medication prescribed to prevent blood clots in patients with an irregular heart rhythm called atrial fibrillation. 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).
Admittedly, the number of cases of colon cancer or liver damage is very small, but this will require careful follow-up to make sure there isn’t a trend developing. Adverse Events, Inc., (AdverseEvents.com) has noted other complications associated with Eliquis that have not made it into the official label. These include heart failure, kidney problems and difficulty swallowing (dysphagia).
Please keep in mind that such adverse drug reports may be coincidental and not related to Eliquis, but they deserve serious attention until we know for sure.
Established Eliquis (Apixaban) Side Effects
What we know with reasonable certainty is that this anticoagulant has some pretty serious adverse effects that are established. They include:
- Serious bleeding in the gastrointestinal tract
- Serious bleeding in the brain (hemorrhagic stroke)
- Serious bleeding within the eye
Blood clots if the drug is stopped suddenly. No one should EVER discontinue Eliquis suddenly without careful medical supervision. This “rebound” clotting effect could trigger life-threatening events.
Spinal procedures such as epidural anesthesia can be very dangerous for people taking Eliquis.
Serious allergic reactions (skin rash, anaphylaxis)
Other, Less Common Side Effects:
- Low blood pressure
- Breathing problems
- Nose bleeds and bleeding gums
- Bleeding at the site of surgery
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.
- SEVERE breathlessness.
- Hypotension (low blood pressure)
- Blurred vision.
- 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. Warfarin has an antidote, Vitamin K, whereas the others don’t…they have nothing to reverse the bleeding if it gets bad!
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…”
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.”
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. Unlike warfarin, neither dabigatran nor rivaroxaban have antidotes to rapidly reverse the anticoagulant effects of treatment. 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.”
Share your own experience with the anticoagulants both positive or negative. Insert your story about Coumadin, Eliquis, Pradaxa or Xarelto in the “What Do You Think” section below.