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Pradaxa Bleed Alert

Pradaxa Alert

Pradaxa Alert (dabigatran) the now not so new blood thinner, was introduced by Boehringer Ingelheim in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation.

Warfarin (brand name Coumadin) was introduced to the marketplace in 1948 not as a medicine but as a rat poison.  It kills rats by causing them to "Bleed Out."

The ever watchful FDA approved warfarin as an anticoagulant, and it remained the choice of treatment for patients with a type of irregular heartbeat - atrial fibrillation -  for more than 50 years.

Medically speaking, warfarin is considered by most physicians as "a pain in the ass."  It interacts negatively with a bunch of other drugs, and because it works in part by interfering with vitamin K, patients have to avoid any foods high in that vitamin like leafy greens, liver, green tea and cauliflower. (or Collard Greens!)

Patients' blood must also be regularly monitored - usually once every three or four days at first, then once or twice a month.  Get your INR(International Normalized Ratio), checked to see how "thick" or "thin" your blood is.  Then you try to find the "Goldilocks Zone" not too thick, and you're at risk of clotting and not too thin, and you risk too much bleeding.

Yet because of its low cost and acceptable success rate (in spite of the complications), this highly annoying, inconvenient treatment has been the standard for the treatment of atrial fibrillation related blood clots.

In the mid-2000s, however, no fewer than eight pharmaceutical companies took a fresh look at this market - why - You guessed it  "MONEY" an estimated market worth $10 billion-$20 billion!

In 2010, Boehringer, a 120-year-old family-owned company, beat everyone to the U.S. market with Pradaxa.  According to the FDA, approximately 1.1 million prescriptions were dispensed between October 2010 and August 2011 and an estimated 371,000 patients filled their prescriptions from outpatient retail pharmacies during that period.

One advantage to these new drugs is that they're more convenient for "us" the patient's because they don't require the close monitoring that warfarin does.   The new anticoagulant drugs have a fixed dose that does not require ongoing monitoring or individual dosing adjustments.

The Problem

Among users of the older, more widely-used blood thinner Coumadin, good old warfarin, bleeding problems can be addressed by giving the patient a shot of good old Vitamin K.

Pradaxa on the other hand DOES NOT HAVE AN ANTIDOTE!!!  Taking Pradaxa? Then you are playing Russian Roulette with a potentially lethal drug?  A blood thinner should not require that you take your life into your hands and hope for the best..

Company representatives also say the risks were not hidden or minimized.  I am sure you have by now seen the "happy" commercials for Pradaxa all over your T.V.  I'll bet you don't remember them saying - if you bump your head and have a significant brain bleed - YOU ARE GOIN' TO DIE!!  I for one would have liked to have known this information before I made up my mind about Pradaxa.  The amazing thing is I took Pradaxa for almost a year and my Doctor NEVER told me of this annoying "side effect."

Pradaxa Case

The University of Utah’s Department of Neurosurgery report the case study of an 83 year-old man who died from a brain hemorrhage caused by Pradaxa. The man was given the blood thinner following a minor head injury sustained in a fall at his home.  Just six hours after Pradaxa was administered, a CT scan showed extensive brain hemorrhaging. The doctors determined there was nothing they could do to save his life due to the lack of a reversal agent for Pradaxa and he died shortly afterward.

The Result - So Far, Not So Good...

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of Pradaxa bleeds were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

A number of individuals throughout the United States are now considering a Pradaxa lawsuit against the drug maker for failing to adequately research the medication or warning about the risk of serious and potentially life-threatening health risks of Pradaxa.

Pradaxa (dabigatran) was only released in October 2010, but there have been more consumer complaints to the FDA’s MedWatch adverse event reporting system during the first three months the anti-clotting drug was available than 98.7% of the other drugs the organization monitors.

A recent study published by the Archives of Internal Medicine warned that the anticoagulant Pradaxa presents serious risks of heart attacks and excess bleeding.

Pradaxa specifically has been found to have many side effects including nausea, stomach pain, diarrhea, allergic reaction, joint pains, dark urine, bleeding and heartburn.  Recent studies have also illustrated that Pradaxa increases the risk of heart attack and excess bleeding.

Studies have shown that there is a 33% increased risk of suffering a heart attack for individuals taking Pradaxa rather than Warfarin (Coumadin) in treating their case of atrial fibrillation.  There is also a risk of excess bleeding when using Pradaxa. These risks are extremely important  - to me!

FDA To The Rescue?

The FDA launched an investigation in December of 2011 to determine whether Pradaxa in fact does create more of a risk of heart attack or excess bleeding than Warfarin.

Despite these risks, healthcare professionals continue to prescribe the drug for its benefits, not only to patients who suffer atrial fibrillation, but also to those who have had joint replacement surgeries.  Researchers and experts continue to warn physicians to be cautious in prescribing the drug due to the recent findings.

Unleash The Lawyers, Jean Casarez

Patients who have taken Pradaxa and have suffered from a heart attack or serious bleeding episode may qualify to file a lawsuit with a Pradaxa Lawyer against the manufacturer of the drug. Many deaths have been recorded and the drug has been shown to cause brain bleeds, intestinal bleeding or other excess bleeding complications.

Another Pradaxa Story

It was December 29, 2011, and Franklin's daughters say today that, had Franklin, 80, not been prescribed a blood thinner called Pradaxa, she'd have lived to see the new year and subsequently celebrate her 60th wedding anniversary.

Instead, they say, the fall caused a blow to her head, which caused an intracranial hemorrhage, which doctors at the hospital could not stop.  All the doctors could do, the daughters say, is make Franklin as comfortable as possible as her speech became slurred and the blood pooled in her skull.

Like hundreds of thousands of others with a heart condition called atrial fibrillation, which raises the risk of stroke, Franklin had been told of the benefits of the recently FDA-approved Pradaxa over its comparatively ancient counterpart, Coumadin.  What she hadn't been told about, according to her daughters, was Pradaxa's most significant drawback: There is no effective reversal agent for a traumatic bleeding event.

Less than 24 hours after Loraine Franklin fell on the kitchen floor of her Georgetown home, she was dead.

Had Franklin been taking Coumadin - as she had years before - she would have left the hospital with a headache and a slight concussion, her daughters say.  With Coumadin, doctors have a variety of ways to keep a patient from bleeding to death.  Instead, according to Franklin's daughters, Pradaxa turned a simple fall into a death sentence.

Which is why Franklin's daughters are suing Pradaxa's German manufacturer, Boehringer Ingelheim, in federal court.  They say the company did not adequately warn doctors and patients of the lack of an antidote. They're just two of dozens of clients represented by the Texas law firm Watts Guerra Craft, whose mass-tort team opened the floodgates by filing the first Pradaxa-related cases in November 2011.

Again - Company representatives also say the risks were not hidden or minimized.

Pradaxa has been a boon to Boehringer's bottom line.  But if Loraine Franklin's daughters get their way, the drug will be off the market - just not soon enough for their mother.

"What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding" from Pradaxa, said Kaul, who served on independent panels that advised the FDA on both new medications.  Kaul said he had written only one prescription for Pradaxa and none for Xarelto.

Ass-et Protection

Boehringer Ingelheim said it is working on an antidote, but declined to elaborate.  Johnson & Johnson said it is not developing an antidote, but is monitoring early efforts by other drugmakers to come up with one.  Bristol-Myers Squibb Co, which is developing a blood clot drug called Eliquis that is similar to Xarelto, declined to comment on the antidote issue.

The nonprofit Institute for Safe Medication Practices estimated last month that 542 reports of deaths associated with Pradaxa were reported to the FDA in 2011, topping all other medicines, including warfarin, with 72 deaths. Adverse event reports on Xarelto were not available.

Bottom Line

All anticoagulant medications present some risk - we all know that - but a drug that allows for uncontrollable bleeding with NO ANTIDOTE!!

I'll stick with Coumadin - or maybe Aspirin?

I you have been prescribed Pradaxa I bet your doctor never told you this.  Always remember the last word in any treatment alternative IS YOURS...


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