That was Dr Mandrola's quote... should have separated my words from his. I wish I were as smart as Dr John!

petey

Petey - I'm sold! It's back to Pradaxa for me. I used to blame Pradaxa for my shortness of breath, but after my ablation I eliminated all my rate and rhythm control medications and took only aspirin and still had shortness of breath. I read on one of these AFIB forums that someone taking Pradaxa for a year blamed it for their acid reflux. Said they never had acid reflux before taking Pradaxa. Only problem was, they also just had an RF ablation, which will give you heartburn in a heartbeat. My shortness of breath and acid reflux are gradually receding post ablation, so I guess I have no excuse for not taking Pradaxa for stroke prevention. My heart monitor has not shown any AFIB episodes since the ablation, but I guess I could have silent AFIB and not know it. Petey, thanks again for accumulating all this information.

PS: Did you ever think about going into sales? You would be great at it.

Jim

Sales?

That's how I stay married.

BTW, I have had no stomach problems with Pradaxa. But my EP had this really wild idea... she said, buy some Prevacid and take it as directed... what an idea! Take Pradaxa and Prevacid if needed: No stroke, no brain bleed, eat all your greens, don't worry about INR... stop watching lawyer ads... crazy! ...almost like being normal! :-) petey

I have an appointment with my cardiologist in August. it's been almost a year since I've seen him. I'm on Warfarin experiencing no problems. I am contacted by his nurse practitioner re; my monthly INR readings, She's been very helpful in answering other concerns I might have.
My INR readings have been consistent in the 2 years I've been on Warfarin. Going for monthly testing is not a problem. The lab is walking distance away. The dietary restriction is also no problem. I eat salads daily and other Vit K foods. My dosage is based taking that into consideration.
I have no objection to switching to Pradaxa if recommended by my cardiologist. Being over 75 is a consideration+ the increased cost.
Paying attention to my triggers I can live with AF. Since stopping BP pills I no longer feel lightheadedness just fatigue until I self convert to NSR. In AF my HR is under 90. My normal heart rate is low. I have been advised a pacemaker may be in my future but not as long as I'm asymptomatic in that regard.

Well, I would say the following three articles (one is from Reuters, one from CBS News, and the other in the Seattle Times-- although-- for disclosure-- it was clearly written from a news release from the legal industry) is a good enough reason not to go on Pradaxa.

My prediction is that Pradaxa will eventually be removed from the market. Did you know Pradaxa leads the FDA MedWatch in more reported fatalities than any other drug last year?

Study: Higher heart attack risk from pradaxa

Patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin.

The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients.

"The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo," Uchino and Hernandez conclude.

More here:
http://www.cbsnews.com/8301-500368_162-57356568/study-higher-heart-attack-risk-from-pradaxa/



Insight: Top heart doctors fret over new blood thinners

(Reuters) - For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

"The good news is you now have an alternative to warfarin," said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. "The bad news is you can kill a patient as easily with the new drug as you could with the old drug" if it is not handled properly.

More here:
http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614

FDA Warns Pradaxa May Lead to Severe Internal Bleeding or Heart Failure


The Safety Communication in the U.S. Food and Drug Administration (FDA) issued a warning on December 7, 2011 that the anti-clotting drug Pradaxa can lead to severe, if not fatal, internal bleeding. According to the FDA's warning, Pradaxa may be likely to cause serious internal bleeding or heart failure that in some cases lead to death.

We have noted on multiple occasions patients who have been bleeding out from Pradaxa and our hands are tied, says Dr. Bryan Cotton of the Center for Translational Injury Research in Houston, Texas. Theyre bleeding out all over and theres absolutely nothing we can do about it. Im helpless when it comes into my emergency room.

With more than 2.6 million Americans diagnosed with Atrial fibrillation, the anti-coagulant drug Pradaxa was prescribed to a great number of Americans to reduce the risk of stroke. The FDA, however, found that the drug may do more damage than good in the December 2011 Safety Communication on Pradaxa. The document reported that of the estimated 371,000 Pradaxa users, 1583 reported gastrointestinal hemorrhage and 466 reported vascular hemorrhage. Fortunately for individuals who have been prescribed Pradaxa, the Pradaxa Lawsuit Center website provides essential information to help gauge their options.

The comprehensive website, http://www.pradaxalawsuitcenter.com, provides answers about heart attack and internal bleeding risks, as well as answers to liability questions that apply to most Pradaxa claims. Additionally, the Pradaxa Lawsuit Center website offers free, no-obligation Pradaxa case reviews to interested parties. While visiting the website, patients have the opportunity to ask professionals any questions about their individual situation and receive an initial personal consultation at no cost. Attorneys representing Pradaxa victims across the country are standing by, available to chat live to answer any questions a patient may have.
These additional concerns deserve serious consideration in weighing the risks and benefits of [Pradaxa], said Archives of Internal Medicine editor Rita Redberg, MD.

For more information about Pradaxa risks and lawsuits, including how to contact a Pradaxa lawyer, please visit http://www.pradaxalawsuitcenter.com/.


Read more: http://interact.stltoday.com/pr/business/PR06291209529546#ixzz1zJmt1Eqg

Before everyone freaks out over the Pradaxa post. Let me briefly address all of this lawyer driven stuff on the web. CBS News, Reuters, Philadelphia enquirer... it is just rehashing some sensationalism that appeared in an article quite awhile ago. First of all, if you click on the link on the post, it also says this:

"Despite the apparent increase in heart attack risk, Uchino and Hernandez note that the benefits of Pradaxa -- particularly its ability to prevent stroke in patients with atrial fibrillation -- outweigh its risks."
"And they note that while the risk of heart attack or acute coronary syndrome is higher in patients on Pradaxa than in those on warfarin, the actual risk of these events is increased by only 0.25% per year."

In other words, heart attack is not a huge risk factor with atrial fibrillation and 33% of a tiny number turns out to be a statistically insignificant number (1/4 of 1%). Pradaxa is saving many more lives by its superiority in preventing strokes.

So forget the heart attack thing. If you actually go to the Cleveland Clinic website, you see none of this. They are not coming out against Pradaxa.

Now the FDA bleeding thing... what you have to realize is that the top 10 list is driven by attorney lawsuits. Lawyers are SOLICITING complaints. The FDA does not get into detail... it is just what is reported by patients (or their attornies). You need only read legitimate websites (medical websites and doctor websites like Dr Mandrola's to get the real deal). BTW, do you know what the drug that is second most reported is (and it is a 60 year old drug that has generics and there is no money in lawsuits suing over the generic? ).... IT's COUMADIN/WARFARIN!!!!!!


But all of this FDA data comes from MEDWATCH... it is not reliable and is driven by solicited lawsuits... read this from the MedWatch report:

"About QuarterWatch Data
Our findings should be interpreted in light of the known limitations of a voluntary reporting system. The FDAs Adverse Event Reporting System (AERS) data combine reports originated by drug manufacturers with cases submitted directly by consumers and health professionals through the agencys MedWatch program. The submission of an individual report does not in itself establish that the suspect drug caused the event describedonly that an observer suspected a relationship."

"A recent story in Forbes noted that last year, warfarin was the second most prevalent drug in FDA safety reports and has been high on the FDA list for many years. It was the subject of 1,106 serious adverse events, including 72 deaths."

Pradaxa Lawsuit Center? Puhleeze!!! That website isn't even worth commenting on.

Please read my posts again... not the Philadelphia or National Enquirer.

If you want to have a laugh, Google Tylenol Lawsuits... now the lawyers are on that bandwagon.

If drug companies are bad, there is nothing worse than attorneys. These scare posts do not help people make good decisions with their doctors. There is no conspiracy. There is no BigFoot, Crop Circle makers from another planet, or Ancient Aliens.

Anticoagulants prevent strokes by making people bleed. That means easier bruising or bleeding.

I tried Pradaxa and was already taking protnix and still got an upset stomach and heartburn. Maybe I just have an extra sensitive stomach.

Some people can't take Pradaxa. Some people can't take Coumadin. Some people can't take Coumadin or Pradaxa.

I have read where people had to take Pradaxa for a month before they adjusted. The reason for this is Pradaxa capsules induce a locally acidic environment (apparently the drug requires acid for absorption.)

Maybe Rivaroxiban will come out on top. But maybe it will have some side effect.

Each drug fits each person's need.

Back to my other post:
Again, I think that posting those weird websites and not digging in to get the real impact serves no-one on AFIB Daily Strength.

I predict all 3 drugs will be around for a long time and that eventually they will find antidoted or modify the drugs.

petey

Petey, we've been down this road before. While I appreciate all the research you do for this forum, you do tend to only present one side of this issue.

That is why I feel it necessary to present the other side. We're talking about the lives of people. They need to make informed decisions based on ALL sides of the story.

Big pharma is big business. It's no wonder why they're promoting a higher priced medication that costs so much more than the old generic. Look at Vioxx, for example. Testimony shows that the drugmaker KNEW about Vioxx's hazards as far back as 1999, yet they hid it from the public.

From the Wall Street Journal

"But internal Merck e-mails and marketing materials as well as interviews with outside scientists show that the company fought forcefully for years to keep safety concerns from destroying the drug's commercial prospects."

You say the legal community is soliciting complaints about Pradaxa. True, but, so what? This is our system of checks and balances. Remember. they solicited complaints about Vioxx before it was pulled from the market.

So back to Pradaxa. Now you have another high priced drug on the market that has already shown to have some potential serious side effects.

Regarding potential heart attacks.. and the quote " And they note that while the risk of heart attack or acute coronary syndrome is higher in patients on Pradaxa than in those on warfarin, the actual risk of these events is increased by only 0.25% per year.

Kirk Garratt, MD, clinical director of interventional cardiology research at New York's Lenox Hill Hospital notes that while the absolute risk might not be bad, when added for patients who already have risk factors for heart disease, "If I have a patient on this drug for 10 years, I'd expect a 5% increased lifetime risk of heart attack," Garratt tells WebMD. "The most important aspect of this study is that it allows us to see a consistent risk across studies and types of patients. That speaks to the conclusion that this study is well done and that the risk is real."

http://www.webmd.com/heart-disease/atrial-fibrillation/news/20120110/pradaxa-heart-attack-risk

Petey, you claim the media is "sensationalizing" the potential deadly side effects of this drug... don't you think that if they were providing false information or exaggerated information they would be sued by the pharmaceutical companies?

What you may not know about the media, is when they do stories of any highly lobbied industry, they run them through a team of lawyers first to check that all their i's are dotted and t's are crossed.

But the BIG deal breaker, in my opinion with Pradaxa, is there is no known remedy. None. You start a big bleed, and you're toast.

I end this post with this from Forbes:

"But the news about dabigatran is not entirely upbeat. According to new data compiled by QuarterWatch (PDF), in 2011 the FDA received more safety reports about dabigatran than any other drug. The data are not entirely unexpected, since the bleeding complications of dabigatran are well known and physicians are more likely to report adverse events associated with new drugs. The drug that dabigatran was designed to replace, warfarin (Coumadin), was the second most reported drug, and has been high on the FDA list for many years.

Dabigatran was the subject of 3,781 serious adverse events reported to the FDA in 2011. This included 542 patient deaths and 2,367 hemorrhages. Warfarin was the subject of 1,106 serious adverse events, including 72 deaths.

QuarterWatch noted that the difference between the two anticoagulants could be at least partly explained by differences in the reporting rate for an older generic drug with many manufacturers, and a newly launched brand name drug being promoted by a large sales force. But, according to QuarterWatch:

What is clear, however, is that the FDAs system is receiving a strong signal about this safety issue. A large share of dabigatran reports (79%) come from health professionals, suggesting that despite this well-known drug risk the bleeding was unexpected or unusually severe.

http://www.forbes.com/sites/larryhusten/2012/06/07/dashboard-store-posts-all-posts-add-new-categories-tags-copy-a-post-media-links-pages-comments-feedbacks-polls-ratings-appearance-users-tools-settings-collapse-menu-help-screen-options-ed/

All drugs have risk. I had just got 90 Vioxx whenever they were recalled.I got a letter from my mail in pharmacy wanting them back explaining the risk. I told them they were not getting them back I was willing to take the risk. If they were available today I would gladly give the lotab back to the pharmacy.

Everything I present is from medical websites... not lawyers. You were scaring people by saying things like I wouldn't touch Pradaxa with a 10 foot pole. I just balanced that statement. I never said I wouldn't touch Coumadin with a 10 foot pole... only that I wasn't worried about having bleeding from trauma as much as I am a stroke or brain bleed. Those lawyer websites are not fact. All the anticoagulants have good and bad points. I can take whatever drug I choose. Money is not an issue. I chose Pradaxa for me. Actually, my doctors did and told me why. On the other hand, my mother in law tried Pradaxa and had to switch to Rivaroxiban (Xarelto) because she is in her mid to late 70s and it bothered her stomach. My brother in law takes Coumadin/Warfarin. I still speak with him. My mother in law was on aspirin when she had a stroke... guess that didn't work very well. That's when she started on Pradaxa. I would consider Xarelto instead of Pradaxa if I thought that was the thing to do and/or my doctors did. BTW, I go to the most renowned centers and doctors who all said that Pradaxa is best for me and not to get concerned with the stuff on the web. I have re-asked the question because I am objective. I read websites like Dr Mandrola (EP) who has afib himself and he still isn't saying get off Pradaxa. Nothing I posted was outside the realm of fact based on data that came from reliable sources. Peace:

http://www.youtube.com/watch?v=rRbyZ3eD-9M


petey

No Petey, I'm not "scaring" them.. I'm giving the facts that you omitted.. so readers can weigh both sides and make their own decisions.

Somebody said you should be a "salesman" and I agree, because you certainly have really been talking up all the pros of Pradaxa and downplaying the very serious risks.

My last post contained three media articles. Only one of them looked to me like it had been written from a legal industry news release, and I disclosed my suspicions But I included it because it still had some very valid information. You say the lawyer websites aren't fact. Can you give me an example? And if they were printing false information, don't you think the drug company would sue them?

The fact that you go to"the most renowned doctors" does nothing to add to your argument. Famous doctors at one time were prescribing Vioxx too.

If you are comfortable taking Pradaxa and have made peace with the risks, terrific. But I think it's doing a disservice to not disclose the very real and very serious risks of Pradaxa. I personally still would not touch Pradaxa with a ten foot pole.

You quoted the article in Reuters but left off the most important paragraph in your exerpt:

"Dr. Robert Temple, a top official in the FDA's Center for Drug Evaluation and Research, said few doctors notify the agency about incidents from warfarin because its risks are already well known. So the lopsided number of Pradaxa reports compared with warfarin may not indicate an elevated risk, he said.
"We don't necessarily believe it is real," he said. "But we're watching it. We can't help but notice it."

This is the last time I am going to respond to you about this subject. I will continue to address anticoagulants however. If you think Coumadin/Warfarin is without safety issues, you are deluding yourself. Coumadin/Warfarin has a history of problems. It is the nature of blood thinners.

I'm done.

Well, I'm NOT done. :)

I never said Coumadin was without risks. Aspirin has risks. Everything has risks.

HOWEVER... Pradaxa has NO REMEDY. That's a biggie. You have a bleed, you could be toast.

It's going to be interesting what comes out once the law suits go to court. That's how we found out all the interesting things about Vioxx.

In my opinion, all blood thinners carry risk. It is for this reason, they are reserved for individuals whose risk of stroke outweighs the risk of bleeding. Regardless of antidote, my grandmother died because of a brain bleed on Coumadin. She was 74 years old. She was on Coumadin after carotid surgery and she also had a pacemaker. She got up in the middle of the night to use the bathroom and slipped when getting back in bed and bumped her head. She didnt realize she had seriously hurt herself until morning when she began to feel sick to her stomach and had a headache. She laid back down after breakfast and never woke up again as she was in a coma due to a subdural hematoma. Perhaps if she had gone to the hospital as soon as she bumped her head, she may not have lost her life. I do not share this story to scare anyone. I share it because no matter what blood thinner you are on, bleeding is a serious consideration and time is of the essence whether there is an antidote or not. Shortly after my grandmothers passing, I was diagnosed with a DVT and was put on Coumadin upon my release from the hospital for 6 months. I was very nervous about the medication, given my grandmother's fall/accident, but knew the risk (pulmonary embolism) was worth taking the medication for. After my 1st ablation, I was on Plavix and aspirin until my second ablation. After my second ablation, I was on Pradaxa for about 1 month. I am only on aspirin now and am still having episodes of AF nearly every day and sometimes I worry whether I am protected enough from stroke. It is those moments of worry that remind me how important it is to weight the risks with the benefits of being on blood thinner. My CHADS score simply doesnt warrant my being on anything more than aspirin, I am otherwise healthy and I have to trust that. However, if my doctor felt differently, I would not hesitate to take a blood thinner and would likely make my choice based on doctor recommendation first, then would consider price and go from there.