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A-Fib & Anticoagulants: Bleeding Risk If combined with OTC meds, Supplements
More than a third (33%) of people taking anticoagulants also take at least one nonprescription drug daily or most days of the week. This combination can cause dangerous side effects.
If you are taking an anticoagulant, such as Eliquis, Xarelto, Pradaxa or Savaysa, be aware that taking it along with some over-the-counter drugs and supplements can cause dangerous internal bleeding.
These over-the-counter drugs include painkillers such as aspirin, Advil (ibuprofen), and Tylenol (acetaminophen) and dietary supplements such as fish oil, turmeric, ginger and other herbs.
Internal Bleeding Risk: NOACs/DOACs Hard to Measure
The older anticoagulant, warfarin, required regular blood tests of INR (International Normalized Ratio) to measure how much warfarin was actually working in a patient’s blood to prevent a stroke.
But the newer anticoagulants (NOACs, DOACs), such as Eliquis, Xarelto, Pradaxa or Savaysa, aren’t normally measured by anticoagulation clinics or health care professionals using standardized tests such as INR. (The FDA, under pressure for new anticoagulants, approved the NOACs without there being any established or universally recognized method of determining their clot preventing effectiveness.)
Be aware that your doctor probably doesn’t test to see how much your NOAC is actually working in you. They hope it is, but doesn’t know for sure. Blood levels of your NOAC depends on factors such as how well or how poorly your kidneys are functioning.
Not all of your NOAC may actually be working for you. Pradaxa, for example, is 80% cleared by the kidneys. This means there may be lower anticoagulant levels in your blood stream, and a lot of your clot prevention is being flushed away by your kidneys. (Eliquis, Xarelto and Savaysa fare better with only 25%, 33% and 35% being cleared by the kidneys, respectively.)
Check With Your Doctor About Increased Internal Bleeding Risk
If you take an anticoagulant along with over-the counter drugs and supplements, ask your doctor which combinations to avoid. But be aware that many doctors are clueless about natural dietary supplements.
(Don’t ask them how effectively your NOAC is working in you. They probably don’t know and can’t easily test for that.)
Magnesium IV to Stop A-Fib
We have long advocated the benefits of Magnesium for A-Fib. (See Magnesium Long-Life Insights for A-Fib Patients.)
Intravenous Delivery: A recent randomized controlled double-blind study found that Magnesium delivered directly into the bloodstream (Intravenous, i.e., IV) can produce both rate and rhythm control when used for A-Fib patients in the emergency room (ER).
The Good News: This study from the University of Monastir, Tunisia, found Magnesium IV is the fastest way to improve Magnesium levels and is very effective in restoring A-Fib patients to normal sinus rhythm.
The Bad News: In U.S. emergency rooms, Magnesium IV is not a standard treatment for A-Fib patients (though it may be used prior to cardioversion). (Dr. Julian Whitaker in Newport Beach, CA performs this therapy (www.drwhitaker.com).)
One of our Advisory Board members wrote me about his large facility’s experience with Magnesium IVs, “A few years ago we tried and stopped because of futility.”
Bottom Line: So it’s an interesting research study, but don’t look for a Magnesium IV if you end up in the ER with an A-Fib episode.
Side Effects of Flecainide: An A-Fib Patient’s Perspective
Carol, from Salem, Oregon, wrote me to share how taking the antiarrhythmic drug, flecainide, affected her.
Flecainide, an antiarrhythmic medication, works by slowing electrical signals in the heart to stabilize the heart rhythm.
“When I initially started taking flecainide for my A-Fib, I experienced annoying visual disturbances, especially when there was a difference between a light and dark environment such as a stage or when going from a light to a dark room. I would see afterimages, many of them. For example, in a theater I’d see my hands clapping, but I’d see many of them as if in a time lapse still photo. Over time that effect got better.
But other side effects developed.
…Here it goes again. I plan to call the Cardiologist as soon as the office opens. I have the following symptoms:
• Irregular heartbeat
• stomach discomfort (bloating)
• rash and hives
• hair loss
• anxiety (my shoulders are practically making contact with my ears)
• sleep problems
• increased sweating
• annoying visual disturbances
These are all listed on the package insert as possible side effects.
However, I am not ready to say they were caused by flecainide as I have had lifelong problems with allergies and digestive issues. Except for the visual disturbances…
I was on flecainide for 12 years―and it mostly worked well―until it didn’t anymore.”
Carol Baumann,
Salem, Oregon
Editor’s Comments
One of the most frequently prescribed antiarrhythmic drugs is flecainide acetate (Tambocor). Flecainide has been around a long time (1985) and is only available as a generic drug.
Instead of a daily dose, fecainide can be used as a “Pill-In-The-Pocket” treatment i.e., taking an antiarrhythmic med at the time of an A-Fib attack.
Flecainide carries an FDA “Black Box Warning” which is the most serious the FDA issues. A Black Box Warning alerts doctors and patients that a drug has potentially dangerous effects.
As with almost all antiarrhythmic drugs, flecainide is known for bad side effects.
To read a detailed description of flecainide, its uses and side effects, see fecainide at MedlinePlus/Drugs, Herbs and Supplements (U.S. National Library of Medicine).
Don’t Want to Take Anticoagulants? Three Alternatives for A-Fib Patients
With Atrial Fibrillation, you are 4–5 times more likely to have an A-Fib (ischemic) stroke. Taking an anticoagulant helps prevent an A-Fib stroke and may give you peace of mind.
The negative side is that all anticoagulants are high-risk medications and inherently dangerous. You bruise easily, cuts take a long time to stop bleeding. You can’t participate in any contact sports. Bleeding events are common complications. There is an increased risk of developing a hemorrhagic stroke and gastrointestinal bleeding. See Risks of Life-Long Anticoagulation.
(Most EPs are well aware of the risks of life-long anticoagulation.)
Don’t want to take anticoagulants? What’s the alternative? Remove the reason you need an anticoagulant!
Three Alternatives to Taking Anticoagulants
Anticoagulants are used with high-risk Atrial Fibrillation patients for the prevention of clots and stroke.
The best way to deal with the increased risk of stroke and side effects of anticoagulants is to no longer need them. Here are three options:
RF Catheter ablation
#1 Alternative: Get rid of your A-Fib.
As electrophysiologist (EP) and prolific blogger Dr. John Mandrola wrote: “…if there is no A-Fib, there is no benefit from anticoagulation.”
Action: Request a catheter ablation procedure. Today, you can have an ablation immediately (called ‘first-line therapy’). You don’t have to waste a year on failed drug therapies. See Catheter Ablation Reduces Stroke Risk Even for Higher Risk Patients
Placing Watchman in LAA
#2 Alternative: Close off your Left Atrial Appendage (LAA).
The Left Atrial Appendage is where 90%-95% of A-Fib clots originate. Closing off the LAA provides similar protection against having an A-Fib (ischemic) stroke as being on an anticoagulant.
Action: Request a Watchman device. The Watchman device is inserted to close off your LAA and keep clots from entering your blood stream. See Watchman Better Than Lifetime on Warfarin
Natural blood thinners
#3 Alternative: Consider non-prescription blood thinners
Perhaps you can benefit from an increase in natural blood thinners such as turmeric, ginger and vitamin E or, especially, the supplement Nattokinase.
Action: Ask your doctor about your CHA2DS2-VASc score (a stroke risk assessor). If your score is a 1 or 2 (out of 10), ask if you could take a non-prescription approach to a blood thinner. See FAQ: “Are natural blood thinners as good as prescription blood thinners?”
Bottom Line
Whether or not to take anticoagulants (and which one) is one of the most difficult decisions you and your doctor must make. To stop taking an anticoagulant, talk to your doctor about alternatives:
• Catheter ablation
• LAA closure (Watchman device)
• Non-prescription blood thinners
These options may help you to no longer need an anticoagulant. As Dr. John Mandrola wrote: “…if there is no A-Fib, there is no benefit from anticoagulation.”
As an A-Fib patient, don’t settle for a lifetime on anticoagulants or blood thinners. Remember: You must be your own best patient advocate.
Unsafe Interaction Between Pradaxa and Common Calcium Channel Blockers
An observational study published in 2020 found that people with A-Fib taking two common rate control calcium channel blockers along with the anticoagulant Pradaxa had higher bleeding rates (GI bleeding, minor bleeding, and minor GI bleeding).
The study was an analysis of the potential drug-drug interaction between verapamil or diltiazem and DOACs.
The term DOAC has replaced use of NOAC.
The study was conducted using US population-based data (2010-2015) analyzed between January 1 and July 15, 2019. Data were obtained on 48,442 patients with nonvalvular atrial fibrillation who had received an index prescription of dabigatran, rivaroxaban, or apixaban.
Analysis was restricted to individuals with no history of kidney disease who were receiving standard doses of the DOACs.
Drug-Drug Interactions Found When Co-Administered
Researchers found that taking the drugs Verapamil and Diltiazem (rate control calcium channel blockers) along with the anticoagulant Pradaxa had higher bleeding rates.
Other anticoagulants such as Xarelto and Eliquis didn’t cause more bleeding. (Apixaban [Eliquis] had consistently lower bleeding event rates among all DOACs.)
(For you technical types, Dabigatran functions as a P-glycoprotein inhibitor (P-gp), an important protein that pumps many foreign substances, such as toxins and drugs, out of cells. Verapamil and diltiazem are also P-gp inhibitors.)
Pradaxa Data Compiled and Compared to Four Calcium Channel Blockers
The investigators compiled data from IBM Watson MarketScan Databases.
Comparisons were made between 1,764 Pradaxa (dabigatran etexilate) users taking verapamil or diltiazem versus 3,105 Pradaxa users taking amlodipine (a calcium channel blocker used primarily to lower blood pressure which isn’t a P-gp inhibitor). The overall bleeding rate was 52% higher compared to amlodipine.
In addition, comparisons were made between 1,793 Pradaxa users taking verapamil or diltiazem versus 3,224 Pradaxa users on metoprolol (a beta-blocker which isn’t a P-gp inhibitor). The overall bleeding rate was 43% higher compared to metoprolol.
Avoid Mixing Pradaxa with Verapamil & Diltiazem
The message of this study is clear. “Clinicians and patients may need to consider alternative DOAC therapy other than dabigatran” when using P-gp inhibitors such as verapamil and diltiazem. (Amiodarone is another P-gp inhibitor.) “It is not safe to combine dabigatran (Pradaxa) with P-glycoprotein (P-gp) inhibitors in people with atrial fibrillation (Afib)” regardless of kidney function.
What This Means to Patients
If you are taking the anticoagulant Pradaxa, along with Verapamil and Diltiazem (rate control calcium channel blockers), talk to your doctor about changing to another DOAC (and take a copy of this article with you).
Happily, there are several DOACs, so there’s seldom an overwhelming need to continue on Pradaxa (dabigatran). Eliquis (apixaban), for example, tested the best and is the safest of the DOACs.
Post Surgery―Develops A-Fib, Drug Therapy & Supplements Restore Sinus Rhythm
My name is Richard, male, and born in 1945. I am 5′ 9’’, weigh 167 lbs., and am a non-smoker. My exercise is walking about 1.5 miles a day, and I have a healthy diet.
Complications from an Appendectomy Surgery―Develops A-Fib
In April 2018 I was in the hospital for three weeks. I had two surgeries, first an appendectomy and 10 days later correction of a problem caused by the first surgery.
After the second surgery I developed A-Fib, with no prior history of it.
The only drug to bring me back to sinus rhythm was Amiodarone. I left the hospital with prescriptions for Amiodarone 100 mg a day and Metoprolol Tartrate 25 mg twice a day.
Amiodarone Damages Thyroid
Everything was under control for several months. Until I had blood work that revealed my Thyroid was not functioning. Amiodarone was removed, and… continue reading Richard’s personal A-Fib story.
Develops A-Fib After Appendectomy Surgery; Lifestyle Changes and Meds Restore Normal Sinus Rhythm
by Richard from Florida, April 2020/May 2021
My name is Richard, male, and born in 1945. I am 5′ 9’’, weigh 167 lbs., and am a non-smoker. My exercise is walking about 1.5 miles a day, and I have a healthy diet.
Complications from an Appendectomy Surgery―Develops A-Fib
In April 2018 I was in the hospital for three weeks. I had two surgeries, first an appendectomy and 10 days later correction of a problem caused by the first surgery.
After the second surgery I developed A-Fib, with no prior history of it.
Surgery is a form of trauma, and this shock depletes magnesium and can lead to heart arrhythmias.
The only drug to bring me back to sinus rhythm was Amiodarone. I left the hospital with prescriptions for Amiodarone 100 mg a day and Metoprolol Tartrate 25 mg twice a day.
Amiodarone Damages Thyroid
Everything was under control for several months until I had blood work that revealed my Thyroid was not functioning.
Amiodarone was removed, and Metoprolol Tartrate was increased to 50 mg twice a day.
Everything was fine for a while when I started having irregular heartbeats periodically. Metoprolol Tartrate was increased to 75 mg twice a day.
Life-Style Changes: Reduced stress with L-Theatine & Kava Tea
At that time, I made some life-style changes. I eliminated caffeine and added the supplement L-Theanine 200 mg three times a day.
The purpose of the supplement was to manage my anxiety, which I believe contributed to the problem. I also replaced coffee with Kava tea and Honey Lavender Stress Relief tea, having one of each a day.
I still had an irregular heartbeat periodically.
A-Flutter, Too! Considered an Ablation But…
I had an EKG, and Atrial Flutter was detected.
I was considering an Ablation but wanted to try a different drug that was not in the antiarrhythmic family.
We finally settled on Diltiazem 120 mg daily plus Metoprolol Tartrate 25 mg twice a day.
I was able to manage anxiety without use of antidepressants or other drugs.
Drug Therapy & Supplements Work: Normal Sinus Rhythm Restored
I have now been symptom free for over 7 months. I attribute my success to the Beta Blocker plus Channel Blocker combination and L-Theanine plus Kava tea to reduce anxiety.
A key point is that I was able to manage anxiety without use of antidepressants or other drugs.
Update: May 2021
Since my initial story I had some episodes of an irregular heartbeat. My prescription for Metoprolol Tartrate was increased from 25mg to 50mg twice a day.
Generally everything is fine now, with an occasional irregular heartbeat when under stress. This is usually short lived.
Lessons Learned
When dealing with a medical condition always consider alternative treatments before selecting invasive procedures (such as catheter ablation).
In this situation alternatives include life-style changes, supplements, and prescription drugs.
If the alternative fails you may always revert to the invasive procedure.
Sincerely,
Richard from Florida
Editor’s Comments
New Onset A-Fib After Surgery: Unfortunately, it’s not unusual to develop A-Fib after both cardiac and non-cardiac surgery. In particular, after bypass surgery new onset A-Fib is reported to occur in 12 to 40 percent of patients.
It’s much less common in cases of non-cardiothoracic surgery such as Richard’s appendectomy (2.5%). Something complicated must have happened to operate on Richard a second time. An appendectomy isn’t a walk in the park. The complication rate is about 18%.
Surgeons often give meds like beta blockers, amiodarone or sotalol to patients before cardiac surgery to prevent new onset A-Fib.
Amiodarone Very Toxic: In Richard’s case, he had life-threatening A-Fib in the hospital, and the use of Amiodarone was justified. But as happens in all too many patients, prolonged use of Amiodarone destroyed Richard’s thyroid. If at all possible, you should try not to take Amiodarone. For more, see Amiodarone Effective But Toxic. For more, see Amiodarone: Most Effective and Most Toxic.
Anxiety Relief: Kudos to Richard for discovering the natural way to reduce his anxiety.
L-theanine is an amino acid found in green and black tea and in certain mushrooms. It’s considered to affect the levels of certain chemicals in the brain such as serotonin and dopamine that influence mood, sleep, and emotion.
Kava Tea (Kava Kava) is a member of the nightshade family of plants, Kava has relaxing and stress-reducing properties and reduces anxiety.
Caution: Kava it has been linked to health concerns. There is some research which indicates that Kava may injure the liver. See LiverTox: Clinical and Research Information on Drug-Induced Liver Injury.
A-Fib Free with Beta Blockers and Calcium Blockers: Beta blockers and calcium channel blockers like Metoprolol and Diltiazem are designed and intended to be rate control meds to keep the heart from beating too fast while remaining in A-Fib.
For Richard they worked to keep him A-Fib free. Maybe they can work for others as well.
We are grateful to Richard for sharing his experience.
Comparing the Effectiveness and Safety of the Direct Oral Anticoagulants (DOACs) in Patients With A-Fib
Anticoagulants are used with high-risk Atrial Fibrillation patients for the prevention of clots and stroke. FDA approved in 2010, Direct Oral Anticoagulant (DOACs) quickly became attractive alternatives to warfarin, the long‐standing standard of care in anticoagulation.
DOACs include dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis). (Edoxaban [Savaysa] approval came later.)
The use of the term “Direct Oral Anticoagulants” (DOACs) has replaced the term NOACs (Novel Oral Anticoagulants), but it means the same.
When the FDA approved DOACs (Direct Oral Anticoagulants), they relied on 3 different clinical trials. But these trials only compared a DOAC, like Eliquis, to warfarin, not to the other DOACs.
Someone like myself had to dig deep into the research to find evidence of which DOAC actually tested better/safer of the three. (I found that Eliquis tested better and was safer.)
For more about the DOACs, see my articles: Warfarin and the New Anticoagulants, and my report from the AF Symposium: The New Anticoagulants.
DOACs: Finally a Head-to-Head Comparison
Today there is clinical data comparing the DOACs against each other. (And support my original reports.)
A comprehensive review of 36 randomized control trials and observational studies included over 1 ¼ million patients. The DOACs compared were apixaban, dabigatran, rivaroxaban, and edoxaban. The reviewers found:
▪ For major bleeding: Eliquis (apixaban) “tended to be safer” than Xarelto (rivaroxaban) and Pradaxa (dabigatran) based on both direct and indirect comparisons;
▪ For best treatment: Eliquis had a higher probability of being the best treatment of decreased risk of stroke/systemic embolism;
▪ Highest benefit: Eliquis had the highest net clinical benefit and smallest NNTnet (Number Needed to Treat for net effect, i.e., how many people were helped by it, how many were harmed.)
Reviewers Conclusions
The researchers wrote: “Apixaban (Eliquis) appeared to have a favorable effectiveness-safety profile compared with the other DOACs (NOACs) in AF for stroke prevention, based on evidence from both direct and indirect comparisons.” (Translation: Eliquis was found to be more effective and safer than the other DOACs).
Editor’s Comments:
In the world of scientific statistics and cautious conclusions, this is about as big an endorsement as you will find: Eliquis is superior to the other anticoagulants.
If you’re on a different DOAC, talk to your doctor about switching to Eliquis.
Know the Risks of Taking Anticoagulants (Blood Thinners): Taking almost any prescription medication has trade-offs. In the case of anticoagulants, on one hand you get protection from having an A-Fib stroke (which often leads to death or severe disability), but on the other hand you have an increased risk of bleeding and other problems. Bleeding events are common complications of anticoogulants.
Is an Anticoagulant Necessary for Me? Be certain you should be on an anticoagulant in the first place. Doctors assess an A-Fib patient’s risk of stroke using a rating scale (called CHA2DS2-VASc). Ask your doctor what’s your risk-of-stroke score. If your score is a 1 or 2 (out of 10), ask if you could take a non-prescription approach to a blood thinner.
Remember Anticoagulants Are High Risk Drugs: Be aware that all anticoagulants are considered high risk drugs.
They aren’t like taking vitamins, though they are certainly better than having an A-Fib (ischemic) stroke. To learn more see: Anticoagulants Increase Risk of Hemorrhagic-Type Strokes.
Q&A: Can Catheter Ablation Be a First-Choice Option?
Q: “I was told that I can’t have a catheter ablation to fix my A-Fib until after at least a year of trying different medications. Is that right? I don’t want to live in A-Fib for a year. I’m very symptomatic. I hate being in A-Fib.”
A: Catheter Ablation Can Be a First-Choice Option. Current Guideline for the Management of Patients with Atrial Fibrillation say you don’t have to wait before getting a catheter ablation. You can have a catheter ablation right away as a first-choice option.
Here is the actual wording of the guidelines:
“The role of catheter ablation as first-line therapy, prior to a trial of a Class I or III antiarrhythmic agent, is an appropriate indication for catheter ablation of AF in patients with symptomatic paroxysmal or persistent AF.”
Guidelines Level of Confidence: Catheter Ablation has a Class IIa Level of Evidence (LOE) indication. This means the “weight of evidence” is in favor of this treatment as useful and effective. (To read more, see Catheter Ablation of AF as First-Line Therapy (p. e307.), in the 2017 HRS/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.)
Drugs First? Your doctor may talk about first trying antiarrhythmic meds. This can waste valuable time as most “antiarrhythmic” drug therapies are only effective about 40% of the time, can have bad side effects, and often become less effective day by day. And, you will most likely still have A-Fib.
Catheter Ablation as a First Choice? If you want to skip the drug therapies, ask your doctor about catheter ablation. If your electrophysiologist won’t talk to you about catheter ablation, seek a second opinion (or change doctors).
As an A-Fib patient, know your rights and be assertive.
2021 AF Symposium: New Technologies and Drugs―Flecainide Inhaler by InCarda
2021 AF Symposium
New Technologies and Drugs―Flecainide Inhaler by InCarda Therapeutics
Jeremy Ruskin, MD
Dr. Jeremy Ruskin of Massachusetts General Hospital gave a 5-minute Spotlight Session talk on InCarda Therapeutics’ flecainide inhaler. InCarda is a privately held biopharmaceutical company in Newark, CA.
Dr. Ruskin described the InCarda inhaler which uses flecainide, a well-established antiarrhythmic agent.
Flecainide Inhaler from Carda Therapeutics
When a patient with recent onset A-Fib self-administers the breath-activated inhaler, it produces a flecainide-containing aerosol when the patient inhales. This results in a rapid absorption of flecainide via the lungs into the heart. An A-Fib attack can be terminated in as little as 8 minutes.
By contrast, if flecainide is taken as a pill-in-the-pocket, it often takes much longer for the pill to work (20-30 minutes).
Aside from the problems associated with flecainide, this inhaler is generally safe and well tolerated.
According to Dr. Ruskin, “Inhaled Flecainide has the potential to be a practical, cost effective option for rapid conversion of AF to sinus rhythm.”
Editor’s Comments
The InCarda flecainide inhaler is already in FDA Phase II trials. But it will probably still be a couple of years before it’s generally available to doctors and patients.
InCarda Inhaler Better Than Pill-In-The-Pocket: The InCarda flecainide inhaler is or will be a welcome addition to Pill-In-The-Pocket therapy where patients only take a drug when it’s needed, not all the time. Today’s antiarrhythmic drugs can have bad side effects and be poorly tolerated if taken all the time. Think of how liberating it would be to just use an inhaler to quickly get out of an A-Fib attack.
One wonders if the InCarda inhaler can be developed for anticoagulants as well. Anticoagulants are high risk drugs especially for older patients.
f you find any errors on this page, email us. Y Last updated: Monday, April 19, 2021
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